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1.  A quantitative approach to measure women’s sexual function using electromyography: A preliminary study of the Kegel exercise 
Background
Currently, the reference standard used to clinically assess sexual function among women is a qualitative questionnaire. Hence, a generalised and quantitative measurement tool needs to be available as an alternative. This study investigated whether an electromyography (EMG) measurement tecnique could be used to help quantify women’s sexual function.
Material/Methods
A preliminary intervention study was conducted on 12 female subjects, who were randomised into a control (n=6) and an intervention (n=6) group. Intervention involved a set regimen of pelvic floor muscle exercises (Kegel) and the control group did not have any treatment. All subjects were asked to answer a validated, self-rated Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ). EMG measurements of the pelvic floor muscles (PFM) and the abdominal muscles were taken from all women at recruitment and 8 weeks after study commencement.
Results
After 8 weeks, most of the subjects in the control group did not display any noted positive difference in either PISQ score (4/6) or in their muscle strength (4/6). However, a noted progressive difference were observed in subjects who were placed in the Kegel group; PISQ score (5/6) and muscles strength (4/6).
Conclusions
The noted difference in the Kegel group subjects was that if progress is observed in the sexual function, improvement is also observed in the strength of at least 2 types of muscles (either abdominal or PFM muscles). Thus, EMG measurement is a potential technique to quantify the changes in female sexual function. Further work will be conducted to validate this assumption.
doi:10.12659/MSM.889628
PMCID: PMC3867621  PMID: 24335927
women’s sexual function; electromyography (EMG) measurement; Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) questionnaires; Kegel exercise
2.  Promoting urinary continence in women after delivery: randomised controlled trial 
BMJ : British Medical Journal  2002;324(7348):1241.
Objectives
To test the effectiveness of a physiotherapist delivered intervention designed to prevent urinary incontinence among women three months after giving birth.
Design
Prospective randomised controlled trial with women randomised to receive the intervention (which entailed training in pelvic floor exercises and incorporated strategies to improve adherence) or usual postpartum care.
Setting
Postpartum wards of three tertiary teaching hospitals in the Hunter region, New South Wales, Australia.
Participants
Women who had forceps or ventouse deliveries or whose babies had a high birth weight (⩾4000 g), or both—676 (348 in the intervention group and 328 in the usual care group) provided endpoint data at three months.
Main outcome measures
Urinary incontinence at three months measured as a dichotomous variable. The severity of incontinence was also measured. Self report of the frequency of performance of pelvic floor exercises was recorded.
Results
At three months after delivery, the prevalence of incontinence in the intervention group was 31.0% (108 women) and in the usual care group 38.4% (125 women); difference 7.4% (95% confidence interval 0.2% to 14.6%, P=0.044). At follow up significantly fewer women with incontinence were classified as severe in the intervention group (10.1%) v (17.0%), difference 7.0%, 1.6% to 11.8%). The proportions of women reporting doing pelvic floor exercises at adequate levels was 84% (80% to 88%) for the intervention group and 58% (52% to 63%) for the usual care group (P=0.001).
Conclusions
The intervention promoting urinary continence reduced the prevalence of urinary incontinence after giving birth, particularly its severity, and promoted the performance of pelvic floor exercises at adequate levels; both continence and adherence to the programme were measured at three months after delivery in women who had forceps or ventouse deliveries or babies weighing 4000 g or more.
What is already known on this topicIntensive pelvic floor exercise programmes can reduce urinary incontinence in selected groups of female patientsThe effectiveness of interventions promoting continence in reducing urinary incontinence in the female population overall has not been investigatedPelvic floor exercises are widely held to be an important component of continence promotion programmesWhat this study addsContinence promotion programmes delivered to a selected population are able to prevent urinary incontinence in that populationFew studies have examined the efficacy of compliance aiding strategies in helping women adhere to prescribed pelvic floor exercise programmes
PMCID: PMC113274  PMID: 12028976
3.  Comparison effect of physiotherapy with surgery on sexual function in patients with pelvic floor disorder: A randomized clinical trial 
Background: Female sexual dysfunction is a common problem among general population, especially in urogynecological patient, and can lead to a decrease in quality of life and affect martial relationship.
Objective: This study was compared the effect of surgical methods versus physiotherapy on sexual function in pelvic floor disorder.
Materials and Methods: This randomized controlled trial was performed in Urogynecology clinic since August 2007 to December 2009 on 90 patients aged from 25-55 years with previous delivery, positive history of sexual dysfunction with stage <3 of pelvic organ prolapsed and divided in two groups. Group A (n=45) received standard rectocele repair and prineorrhaphy, group B (n=45) received physiotherapy for eight weeks twice a week (electrical stimulation, Kegel exercises). The female sexual function index (FSFI) used to evaluate the sexual function in cases before and after intervention. Frequency of variable scores (libido, orgasm, dysparunia) included without disorder, frequently good, sometimes good, very much and extreme were compared between two groups.
Results: Libido and arousal were improved in both groups (p=0.007, p=0.001 respectively). Orgasm and dyspareunia were improved in group B (p=0.001). Dysparunia was more painful in group A. There was significant difference between two groups (improvement of orgasm and dysparunia in group B) (p=0.001).
Conclusion: It seems that physiotherapy is an appropriate method for treatment of sexual disorder in pelvic floor disorder.
Registration ID in IRCT: IRCT2013031112790N1.
PMCID: PMC4009589  PMID: 24799856
Pelvic floor; FSFI; Sexual dysfunction; Physiotherapy; Physical Therapy; Pelvic surgery
4.  Comparison of pelvic floor muscle strength evaluations in nulliparous and primiparous women: a prospective study 
Clinics  2011;66(8):1389-1393.
OBJECTIVE:
This study aimed to compare the pelvic floor muscle strength of nulliparous and primiparous women.
METHODS:
A total of 100 women were prospectively distributed into two groups: Group 1 (G1) (n = 50) included healthy nulliparous women, and Group 2 (G2) (n = 50) included healthy primiparous women. Pelvic floor muscle strength was subjectively evaluated using transvaginal digital palpation. Pelvic floor muscle strength was objectively assessed using a portable perineometer. All of the parameters were evaluated simultaneously in G1 and were evaluated in G2 during the 20th and 36th weeks of pregnancy and 45 days after delivery.
RESULTS:
In G2, 14 women were excluded because they left the study before the follow-up evaluation. The median age was 23 years in G1 and 22 years in G2; there was no significant difference between the groups. The average body mass index was 21.7 kg/m2 in G1 and 25.0 kg/m2 in G2; there was a significant difference between the groups (p = 0.0004). In G2, transvaginal digital palpation evaluation showed significant impairments of pelvic floor muscle strength at the 36th week of pregnancy (p = 0.0006) and 45 days after vaginal delivery (p = 0.0001) compared to G1. Objective evaluations of pelvic floor muscle strength in G2 revealed a significant decrease 45 days after vaginal delivery compared to nulliparous patients.
CONCLUSION:
Pregnancy and vaginal delivery may cause weakness of the pelvic floor muscles.
doi:10.1590/S1807-59322011000800014
PMCID: PMC3161217  PMID: 21915489
Musculature Strength; Nulliparous; Pelvic Floor Muscle; Primiparous
5.  A pilot randomized trial of conventional versus advanced pelvic floor exercises to treat urinary incontinence after radical prostatectomy: a study protocol 
BMC Urology  2015;15:94.
Background
Radical prostatectomy is the most common and effective treatment for localized prostate cancer. Unfortunately, radical prostatectomy is associated with urinary incontinence and has a significant negative impact on quality of life. Pelvic floor exercises are the most common non-invasive management strategy for urinary incontinence following radical prostatectomy; however, studies provide inconsistent findings regarding their efficacy. One potential reason for sub-optimal efficacy of these interventions is the under-utilization of regional muscles that normally co-activate with the pelvic floor, such as the transverse abdominis, rectus abdominis, and the diaphragm. Two novel approaches to improve urinary continence recovery are ‘Pfilates’ and ‘Hypopressives’ that combine traditional pelvic floor exercises with the activation of additional supportive muscles. Our study will compare an advanced pelvic floor exercise training program that includes Pfilates and Hypopressives, to a conventional pelvic floor exercises regimen for the treatment of post-radical prostatectomy urinary incontinence.
Methods/Design
This is a pilot, randomized controlled trial of advanced pelvic floor muscle training versus conventional pelvic floor exercises for men with localized prostate cancer undergoing radical prostatectomy. Eighty-eight men who will be undergoing radical prostatectomy at hospitals in Toronto, Canada will be recruited. Eligible participants must not have undergone androgen deprivation therapy and/or radiation therapy. Participants will be randomized 1:1 to receive 26 weeks of the advanced or conventional pelvic floor exercise programs. Each program will be progressive and have comparable exercise volume. The primary outcomes are related to feasibility for a large, adequately powered randomized controlled trial to determine efficacy for the treatment of urinary incontinence. Feasibility will be assessed via recruitment success, participant retention, outcome capture, intervention adherence, and prevalence of adverse events. Secondary outcomes of intervention efficacy include measures of pelvic floor strength, urinary incontinence, erectile function, and quality of life. Secondary outcome measures will be collected prior to surgery (baseline), and at 2, 6, 12, 26-weeks post-operatively.
Discussion
Pfilates and Hypopressives are novel approaches to optimizing urinary function after radical prostatectomy. This trial will provide the foundation of data for future, large-scale trials to definitively describe the effect of these advanced pelvic floor exercise modalities compared to conventional pelvic floor exercise regimes for men with prostate cancer undergoing radical prostatectomy
Trial registration
Clinicalstrials.gov Identifier: NCT02233608.
doi:10.1186/s12894-015-0088-4
PMCID: PMC4574075  PMID: 26377550
6.  Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women 
BMJ : British Medical Journal  1999;318(7182):487-493.
Objective
To compare the effect of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment for genuine stress incontinence.
Design
Stratified, single blind, randomised controlled trial.
Setting
Multicentre.
Participants
107 women with clinically and urodynamically proved genuine stress incontinence. Mean (range) age was 49.5 (24-70) years, and mean (range) duration of symptoms 10.8 (1-45) years.
Interventions
Pelvic floor exercise (n=25) comprised 8-12 contractions 3 times a day and exercise in groups with skilled physical therapists once a week. The electrical stimulation group (n=25) used vaginal intermittent stimulation with the MS 106 Twin at 50 Hz 30 minutes a day. The vaginal cones group (n=27) used cones for 20 minutes a day. The untreated control group (n=30) was offered the use of a continence guard. Muscle strength was measured by vaginal squeeze pressure once a month.
Main outcome measures
Pad test with standardised bladder volume, and self report of severity.
Results
Improvement in muscle strength was significantly greater (P=0.03) after pelvic floor exercises (11.0 cm H2O (95% confidence interval 7.7 to 14.3) before v 19.2 cm H2O (15.3 to 23.1) after) than either electrical stimulation (14.8 cm H2O (10.9 to 18.7) v 18.6 cm H2O (13.3 to 23.9)) or vaginal cones (11.8 cm H2O (8.5 to 15.1) v 15.4 cm H2O (11.1 to 19.7)). Reduction in leakage on pad test was greater in the exercise group (−30.2 g; −43.3 to 16.9) than in the electrical stimulation group (−7.4 g; −20.9 to 6.1) and the vaginal cones group (−14.7 g; −27.6 to −1.8). On completion of the trial one participant in the control group, 14 in the pelvic floor exercise group, three in the electrical stimulation group, and two in the vaginal cones group no longer considered themselves as having a problem.
Conclusion
Training of the pelvic floor muscles is superior to electrical stimulation and vaginal cones in the treatment of genuine stress incontinence.
Key messagesTraining to increase the strength of pelvic floor muscles was superior to electrical stimulation and vaginal cones in treatment of genuine stress incontinenceAdverse effects were reported with use of electrical stimulation and vaginal cones but not with exercisesPatients’ tolerance for electrical stimulation and vaginal cones was lowPelvic floor exercise should be first choice of treatment for genuine stress incontinence
PMCID: PMC27740  PMID: 10024253
7.  Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse: randomised controlled trial in primary care 
Objective To compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse.
Design Randomised controlled trial.
Setting Dutch primary care.
Participants Women aged 55 years or over with symptomatic mild prolapse (leading edge above the hymen) were identified by screening. Exclusion criteria were current prolapse treatment or treatment in the previous year, malignancy of pelvic organs, current treatment for another gynaecological disorder, severe/terminal illness, impaired mobility, cognitive impairment, and insufficient command of the Dutch language.
Interventions Pelvic floor muscle training versus watchful waiting.
Main outcome measures The primary outcome was change in bladder, bowel, and pelvic floor symptoms measured with the Pelvic Floor Distress Inventory-20 (PFDI-20), three months after the start of treatment. Secondary outcomes were changes in condition specific and general quality of life, sexual function, degree of prolapse, pelvic floor muscle function, and patients’ perceived change in symptoms.
Results Of the 287 women who were randomised to pelvic floor muscle training (n=145) or watchful waiting (n=142), 250 (87%) completed follow-up. Participants in the intervention group improved by (on average) 9.1 (95% confidence interval 2.8 to 15.4) points more on the PFDI-20 than did participants in the watchful waiting group (P=0.005). Of women in the pelvic floor muscle training group, 57% (82/145) reported an improvement in overall symptoms from the start of the study compared with 13% (18/142) in the watchful waiting group (P<0.001). Other secondary outcomes showed no significant difference between the groups.
Conclusions Although pelvic floor muscle training led to a significantly greater improvement in PFDI-20 score, the difference between the groups was below the presumed level of clinical relevance (15 points). Nevertheless, 57% of the participants in the intervention group reported an improvement of overall symptoms. More studies are needed to identify factors related to success of pelvic floor muscle training and to investigate long term effects.
Trial registration Dutch Trial Register (www.trialregister.nl) identifier: NTR2047.
doi:10.1136/bmj.g7378
PMCID: PMC4273538  PMID: 25533442
8.  Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse: randomised controlled trial in primary care 
The BMJ  2014;349:g7378.
Objective To compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse.
Design Randomised controlled trial.
Setting Dutch primary care.
Participants Women aged 55 years or over with symptomatic mild prolapse (leading edge above the hymen) were identified by screening. Exclusion criteria were current prolapse treatment or treatment in the previous year, malignancy of pelvic organs, current treatment for another gynaecological disorder, severe/terminal illness, impaired mobility, cognitive impairment, and insufficient command of the Dutch language.
Interventions Pelvic floor muscle training versus watchful waiting.
Main outcome measures The primary outcome was change in bladder, bowel, and pelvic floor symptoms measured with the Pelvic Floor Distress Inventory-20 (PFDI-20), three months after the start of treatment. Secondary outcomes were changes in condition specific and general quality of life, sexual function, degree of prolapse, pelvic floor muscle function, and patients’ perceived change in symptoms.
Results Of the 287 women who were randomised to pelvic floor muscle training (n=145) or watchful waiting (n=142), 250 (87%) completed follow-up. Participants in the intervention group improved by (on average) 9.1 (95% confidence interval 2.8 to 15.4) points more on the PFDI-20 than did participants in the watchful waiting group (P=0.005). Of women in the pelvic floor muscle training group, 57% (82/145) reported an improvement in overall symptoms from the start of the study compared with 13% (18/142) in the watchful waiting group (P<0.001). Other secondary outcomes showed no significant difference between the groups.
Conclusions Although pelvic floor muscle training led to a significantly greater improvement in PFDI-20 score, the difference between the groups was below the presumed level of clinical relevance (15 points). Nevertheless, 57% of the participants in the intervention group reported an improvement of overall symptoms. More studies are needed to identify factors related to success of pelvic floor muscle training and to investigate long term effects.
Trial registration Dutch Trial Register (www.trialregister.nl) identifier: NTR2047.
doi:10.1136/bmj.g7378
PMCID: PMC4273538  PMID: 25533442
9.  Behavioral Intervention Program versus Vaginal Cones on Stress Urinary Incontinence and Related Quality of Life: A Randomized Clinical Trial 
Oman Medical Journal  2014;29(1):32-38.
Objective
To compare the efficacy of behavioral intervention program and vaginal cones on stress urinary incontinence.
Methods
In this randomized clinical trial, 60 women aged 25-65 years with stress urinary incontinence were randomly divided into two groups, those who participated in a behavioral intervention program (n=30) and those who used vaginal cones (n=30). The women in the behavioral intervention group were instructed on pelvic floor exercise and bladder control strategies. In the other group, pelvic floor exercises were performed using the vaginal cones. All participants were treated for 12 weeks and followed-up every 2 weeks. The subjective changes in severity of stress urinary incontinence were measured using a detection stress urinary incontinence severity questionnaire, leakage index, and a 3-day urinary diary. The objective changes were measured by pad test. For better evaluation of the effects, two questionnaires were used: Incontinence Quality of Life and King’s Health Questionnaire.
Results
Among the 51 women who completed the study, 25 subjects were in the vaginal cones group and 26 participated in the behavioral intervention program. The changes in leakage rate on pad test and leakage index in the behavioral intervention program group were significantly higher than in the vaginal cones group (p=0.001 and p=0.008, respectively), but the severity of stress urinary incontinence was not significantly different between the two groups (p=0.2). The changes in strength of the pelvic floor, Incontinence Quality of Life, and King’s Health Questionnaire scores showed no significant differences between the two groups after 12 weeks of intervention.
Conclusion
Vaginal cones and behavioral intervention programs are both effective methods of treatment for mild to moderate stress urinary incontinence, but the behavioral intervention program is superior to vaginal cones in terms of cost-effectiveness and side effects.
doi:10.5001/omj.2014.08
PMCID: PMC3910410  PMID: 24498480
Behavioral intervention program; Vaginal cones; Stress urinary incontinence
10.  The effect of water immersion delivery on the strength of pelvic floor muscle and pelvic floor disorders during postpartum period 
Medicine  2017;96(41):e8124.
Abstract
Background:
Water immersion delivery is a non-pharmacological approach to ease labor pain. This paper aims to investigate the effect of water immersion delivery on increasing strength of pelvic floor muscle (PFM) and relieving pelvic floor disorders (PFDs) during postpartum period.
Methods:
A total of 2749 vaginal-delivery primiparas in postpartum 6-8 weeks were selected as research objects. Based on the modes of delivery, 600 patients were assigned into water immersion delivery group, 2149 were assigned into conventional delivery group. The scales of PFM strength and pelvic organ prolapsed (POP) were determined by specially trained personnel using digital palpation, and the symptoms of stress urinary incontinence (SUI) were investigated by questionnaire survey. The weak PFM strength was improved by doing Kegel exercise at home for 6-8 weeks.
Results:
We found that ①The rate of episiotomy in water immersion delivery group was 77.50% (465/600), which was lower than that in conventional delivery group (84.69%, 1820/2149) (P < .01); The primiparas without having an episiotomy have higher PFM strength than those having an episiotomy for both groups (P < .01). ②There was a negative correlation between the scale of PFM strength and SUI or POP, wherein the r-values were −0.135 and −0.435, respectively (P < .01). ③The rate of SUI was 6.50% (39/600) in water immersion delivery group and 6.89% (148/2149) in the conventional delivery group, wherein the intergroup difference was not significant (P > .05); ④The rates of vaginal wall prolapsed and uterus prolapsed were 29.83% (179/600) and 2.83% (17/600) in water immersion delivery group and 30.95% (665/2149) and 4.37% (94/2149) in the conventional delivery group, wherein the intergroup difference was not significant (P > .05). ⑤After Kegel exercise, the strength of PFM was promoted (P < .01).
Conclusion:
Water immersion delivery has been proved to a beneficial alternative method for conventional delivery method. This delivery mode is associated with fewer episiotomy rate, and avoiding episiotomy is beneficial for maintaining PFM strength of women in postpartum 6-8 weeks. The strength of PFM during postpartum period can be improved by doing Kegel exercise at home.
doi:10.1097/MD.0000000000008124
PMCID: PMC5662303  PMID: 29019880
pelvic floor disorders; pelvic floor muscle; water immersion delivery
11.  Pelvic floor muscle strength in primiparous women according to the delivery type: cross-sectional study 1  
ABSTRACT
Objectives:
to compare the pelvic floor muscle strength in primiparous women after normal birth and cesarean section, related to the socio-demographic characteristics, nutritional status, dyspareunia, urinary incontinence, perineal exercise in pregnancy, perineal condition and weight of the newborn.
Methods:
this was a cross-sectional study conducted after 50 - 70 postpartum days, with 24 primiparous women who underwent cesarean delivery and 72 who had a normal birth. The 9301 PeritronTM was used for analysis of muscle strength. The mean muscle strength was compared between the groups by two-way analysis of variance.
Results:
the pelvic floor muscle strength was 24.0 cmH2O (±16.2) and 25.4 cmH2O (±14.7) in postpartum primiparous women after normal birth and cesarean section, respectively, with no significant difference. The muscular strength was greater in postpartum women with ≥ 12 years of study (42.0 ±26.3 versus 14.6 ±7.7 cmH2O; p= 0.036) and in those who performed perineal exercises (42.6±25.4 11.8±4.9 vs. cmH2O; p = 0.010), compared to caesarean. There was no difference in muscle strength according to delivery type regarding nutritional status, dyspareunia, urinary incontinence, perineal condition or newborn weight.
Conclusion:
pelvic floor muscle strength does not differ between primiparous women based on the type of delivery. Postpartum women with normal births, with higher education who performed perineal exercise during pregnancy showed greater muscle strength.
doi:10.1590/1518-8345.0926.2758
PMCID: PMC4996086  PMID: 27533267
Muscle Strength; Perineum; Postpartum Period; Obstetric Nursing
12.  Effects of Combined Spinal-Epidural Analgesia during Labor on Postpartum Electrophysiological Function of Maternal Pelvic Floor Muscle: A Randomized Controlled Trial 
PLoS ONE  2015;10(9):e0137267.
Objective
Combined spinal-epidural analgesia (CSEA) is sometimes used for difficult births, but whether it contributes to postpartum pelvic muscle disorder is unclear. This randomized controlled trial examined whether CSEA given during labor affects the electrophysiological index of postpartum pelvic floor muscle function.
Methods
A consecutive sample of primiparous women who delivered vaginally at term were randomly assigned to a CSEA group (n = 143) and control group (n = 142) between June 2013 and June 2014. All were assessed 6–8 weeks later for electrophysiological function of pelvic floor muscle.
Results
The two groups were similar in the degree of muscle strength, muscle fatigue, and pelvic dynamic pressure of pelvic floor muscle. The CSEA and control groups showed similar proportions of women with normal muscle strength (score ≥4) in type I pelvic fibers (23.1% vs. 14.1%, P = 0.051) and type II pelvic fibers (28.0% vs. 24.6%, P = 0.524). The groups also contained similar proportions of women who showed no fatigue in type I fibers (54.5% vs. 48.6%, P = 0.315) or type II fibers (88.8% vs. 87.3%, P = 0.699). Similarly low proportions of women in the CSEA group and control group showed normal pelvic dynamic pressure (11.2% vs. 7.7%, P = 0.321). However, women in the CSEA group spent significantly less time in labor than those in the control group (7.25 vs. 9.52 h, P <0.001).
Conclusions
CSEA did not affect the risk of postpartum pelvic muscle disorder in this cohort of primiparous women who gave birth vaginally. A significant shorter duration of labour was observed in the CSEA-group.
Trial Registration
ClinicalTrials.gov NCT02334150
doi:10.1371/journal.pone.0137267
PMCID: PMC4560435  PMID: 26340002
13.  Conservative management of persistent postnatal urinary and faecal incontinence: randomised controlled trial 
BMJ : British Medical Journal  2001;323(7313):593.
Objectives
To assess the effect of nurse assessment with reinforcement of pelvic floor muscle training exercises and bladder training compared with standard management among women with persistent incontinence three months postnatally.
Design
Randomised controlled trial with nine months' follow up.
Setting
Community intervention in three centres (Dunedin, New Zealand; Birmingham; Aberdeen).
Participants
747 women with urinary incontinence three months postnatally, allocated at random to intervention (371) or control (376) groups.
Intervention
Assessment by nurses of urinary incontinence with conservative advice on pelvic floor exercises at five, seven, and nine months after delivery supplemented with bladder training if appropriate at seven and nine months.
Main outcome measures
Primary: persistence and severity of urinary incontinence 12 months after delivery. Secondary: performance of pelvic floor exercises, change in coexisting faecal incontinence, wellbeing, anxiety, and depression.
Results
Women in the intervention group had significantly less urinary incontinence: 167/279 (59.9%) v 169/245 (69.0%), difference 9.1% (95% confidence interval 1.0% to 17.3%, P=0.037) for any incontinence and 55/279 (19.7%) v 78/245 (31.8%), difference 12.1% (4.7% to 19.6%, P=0.002) for severe incontinence. Faecal incontinence was also less common: 12/273 (4.4%) v 25/237 (10.5%), difference 6.1% (1.6% to 10.8%, P=0.012). At 12 months women in the intervention group were more likely to be performing pelvic floor exercises (218/278 (79%) v 118/244 (48%), P<0.001).
Conclusions
A third of women may have some urinary incontinence three months after childbirth. Conservative management provided by nurses seems to reduce the likelihood of urinary and coexisting faecal incontinence persisting 12 months postpartum. Further trials for faecal incontinence are needed.
What is already known on this topicVaginal delivery is a risk factor for urinary incontinenceThree months after childbirth 20-30% of women still experience urinary incontinenceMost women do not seek treatmentWhat this study addsWomen will use conservative treatments such as pelvic floor exercises or bladder trainingConservative management prevents persistent urinary incontinence in about one in 10 women who have postnatal incontinenceCoexisting persistent faecal incontinence is also improved
PMCID: PMC55571  PMID: 11557703
14.  A pilot randomized control trial to evaluate pelvic floor muscle training for urinary incontinence among gynecologic cancer survivors 
Gynecologic oncology  2013;132(1):154-158.
Objectives
We previously reported high rates of urinary incontinence among gynecologic cancer survivors and aimed to evaluate the effectiveness of a simple intervention for treatment of urinary incontinence in this population.
Methods
We recruited 40 gynecologic cancer survivors who reported urinary incontinence on a validated questionnaire. Women were randomized to either pelvic floor muscle training/behavioral therapy (treatment group) or usual care (control group). The primary outcome measure, assessed at 12 weeks post intervention, was a 40% difference in the validated Patient Global Impression of Improvement (PGI-I) score. Fisher’s exact test was used to identify differences between groups for frequency data; two sample t-test was conducted for continuous measurements.
Results
Mean age of this cohort was 57 (range: 37–79). The majority of the survivors had uterine cancer (60%), 18% had received radiation therapy, 95% had received surgical therapy, and 35% had received chemotherapy. At three months, 80% of the treatment and 40% of the control group reported that their urinary incontinence was “much better” or “very much better” as evaluated by the Patient Global Impression of Improvement scale (p = 0.02). Brink’s scores were significantly improved in the treatment group as compared to those of the controls (p < 0.0001). Treatment group adherence was high; the treatment group performed exercises with an average of 22 days/month.
Conclusions
Urinary incontinence negatively affects quality of life, and despite a high prevalence among gynecologic cancer survivors, it is often under-assessed and undertreated. We found a simple intervention that included pelvic floor muscle training and behavioral therapy, which significantly improved cancer survivor’s urinary incontinence.
doi:10.1016/j.ygyno.2013.10.024
PMCID: PMC5399541  PMID: 24183730
Cancer survivorship; Quality of life; Urinary incontinence
15.  Assessment of the effect of pelvic floor exercises on pelvic floor muscle strength using ultrasonography in patients with urinary incontinence: a prospective randomized controlled trial 
[Purpose] The aim of this study was to evaluate whether the effect of pelvic floor exercises on pelvic floor muscle strength could be detected via ultrasonography in patients with urinary incontinence. [Subjects and Methods] Of 282 incontinent patients, 116 participated in the study and were randomly divided into a pelvic floor muscle training (n=65) group or control group (n=51). The pelvic floor muscle training group was given pelvic floor exercise training for 12 weeks. Both groups were evaluated at the beginning of the study and after 12 weeks. Abdominal ultrasonography measurements in transverse and longitudinal planes, the PERFECT scheme, perineometric evaluation, the stop test, the stress test, and the pad test were used to assess pelvic floor muscle strength in all cases. [Results] After training, the PERFECT, perineometry and transabdominal ultrasonography measurements were found to be significantly improved, and the stop test and pad test results were significantly decreased in the pelvic floor muscle training group, whereas no difference was observed in the control group. There was a positive correlation between the PERFECT force measurement scale and ultrasonography force measurement scale before and after the intervention in the control and pelvic floor muscle training groups (r=0.632 and r=0.642, respectively). [Conclusion] Ultrasonography can be used as a noninvasive method to identify the change in pelvic floor muscle strength with exercise training.
doi:10.1589/jpts.28.360
PMCID: PMC4792974  PMID: 27065519
Pelvic floor muscle; Transabdominal ultrasonography; Urinary incontinence
16.  Involuntary reflexive pelvic floor muscle training in addition to standard training versus standard training alone for women with stress urinary incontinence: study protocol for a randomized controlled trial 
Trials  2015;16:524.
Background
Pelvic floor muscle training is effective and recommended as first-line therapy for female patients with stress urinary incontinence. However, standard pelvic floor physiotherapy concentrates on voluntary contractions even though the situations provoking stress urinary incontinence (for example, sneezing, coughing, running) require involuntary fast reflexive pelvic floor muscle contractions. Training procedures for involuntary reflexive muscle contractions are widely implemented in rehabilitation and sports but not yet in pelvic floor rehabilitation. Therefore, the research group developed a training protocol including standard physiotherapy and in addition focused on involuntary reflexive pelvic floor muscle contractions.
Methods/design
The aim of the planned study is to compare this newly developed physiotherapy program (experimental group) and the standard physiotherapy program (control group) regarding their effect on stress urinary incontinence. The working hypothesis is that the experimental group focusing on involuntary reflexive muscle contractions will have a higher improvement of continence measured by the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence (short form), and — regarding secondary and tertiary outcomes — higher pelvic floor muscle activity during stress urinary incontinence provoking activities, better pad-test results, higher quality of life scores (International Consultation on Incontinence Modular Questionnaire) and higher intravaginal muscle strength (digitally tested) from before to after the intervention phase. This study is designed as a prospective, triple-blinded (participant, investigator, outcome assessor), randomized controlled trial with two physiotherapy intervention groups with a 6-month follow-up including 48 stress urinary incontinent women per group. For both groups the intervention will last 16 weeks and will include 9 personal physiotherapy consultations and 78 short home training sessions (weeks 1–5 3x/week, 3x/day; weeks 6–16 3x/week, 1x/day). Thereafter both groups will continue with home training sessions (3x/week, 1x/day) until the 6-month follow-up.
To compare the primary outcome, International Consultation on Incontinence Modular Questionnaire (short form) between and within the two groups at ten time points (before intervention, physiotherapy sessions 2–9, after intervention) ANOVA models for longitudinal data will be applied.
Discussion
This study closes a gap, as involuntary reflexive pelvic floor muscle training has not yet been included in stress urinary incontinence physiotherapy, and if shown successful could be implemented in clinical practice immediately.
Trial registration
NCT02318251; 4 December 2014
First patient randomized: 11 March 2015
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-015-1051-0) contains supplementary material, which is available to authorized users.
doi:10.1186/s13063-015-1051-0
PMCID: PMC4647572  PMID: 26573847
Electromyography; Exercise; Muscle contraction; Pelvic floor; Reflex
17.  A comparison between stabilization exercises and pelvic floor muscle training in women with pelvic organ prolapse 
Objective:
This study aimed to compare the effectiveness of stabilization exercises and pelvic floor muscle training in women with stage 1 and 2 pelvic organ prolapse.
Materials and Methods:
In a total 38 women with pelvic organ prolapse whose average age was 45.60 years, pelvic floor muscles were evaluated with electromyography, and prolapse with pelvic organ prolapse quantification system, and the quality of life with prolapse quality of life questionnaire. Afterwards, the subjects were divided into two groups; stabilization exercise group (n=19) and pelvic floor muscle training group (n=19). Stabilization exercise group were given training for 8 weeks, 3 times a week. Pelvic floor muscle training group were given eight-week home exercises. Each group was assessed before training and after eight weeks.
Results:
An increase was found in the pelvic muscle activation response in the 2 groups (p≤0.05). There was no difference in EMG activity values between the groups (p>0.05). A difference was found in the values Aa, Ba and C in subjects of each group (p≤0.05), and the TVL, Ap, Bp and D values of subjects in pelvic floor muscle training group (p≤0.05) in the before and after pelvic organ prolapse quantification system assessment, however, no difference was found between the groups (p≤0.05). A positive difference was found in the effect of prolapse sub parameter in each of the two groups, and in general health perception sub parameter in subjects of stabilization exercise group (p<0.05) in the prolapse quality of life questionnaire.
Conclusions:
It was concluded that both training programs increased the pelvic floor muscle strength, provided a decline in prolapse stages. Stabilization exercise has increased general health perception unlike home training, thus, these exercises can be added to the treatment of women with prolapse.
doi:10.4274/tjod.74317
PMCID: PMC5558398  PMID: 28913034
Pelvic organ prolapse; pelvic floor; stabilization exercises; home training
18.  The Long-Term Effects of a Peer-Led Sex Education Programme (RIPPLE): A Cluster Randomised Trial in Schools in England 
PLoS Medicine  2008;5(11):e224.
Background
Peer-led sex education is widely believed to be an effective approach to reducing unsafe sex among young people, but reliable evidence from long-term studies is lacking. To assess the effectiveness of one form of school-based peer-led sex education in reducing unintended teenage pregnancy, we did a cluster (school) randomised trial with 7 y of follow-up.
Methods and Findings
Twenty-seven representative schools in England, with over 9,000 pupils aged 13–14 y at baseline, took part in the trial. Schools were randomised to either peer-led sex education (intervention) or to continue their usual teacher-led sex education (control). Peer educators, aged 16–17 y, were trained to deliver three 1-h classroom sessions of sex education to 13- to 14-y-old pupils from the same schools. The sessions used participatory learning methods designed to improve the younger pupils' skills in sexual communication and condom use and their knowledge about pregnancy, sexually transmitted infections (STIs), contraception, and local sexual health services. Main outcome measures were abortion and live births by age 20 y, determined by anonymised linkage of girls to routine (statutory) data. Assessment of these outcomes was blind to sex education allocation. The proportion of girls who had one or more abortions before age 20 y was the same in each arm (intervention, 5.0% [95% confidence interval (CI) 4.0%–6.3%]; control, 5.0% [95% CI 4.0%–6.4%]). The odds ratio (OR) adjusted for randomisation strata was 1.07 (95% CI 0.80–1.42, p = 0.64, intervention versus control). The proportion of girls with one or more live births by 20.5 y was 7.5% (95% CI 5.9%–9.6%) in the intervention arm and 10.6% (95% CI 6.8%–16.1%) in the control arm, adjusted OR 0.77 (0.51–1.15). Fewer girls in the peer-led arm self-reported a pregnancy by age 18 y (7.2% intervention versus 11.2% control, adjusted OR 0.62 [95% CI 0.42–0.91], weighted for non-response; response rate 61% intervention, 45% control). There were no significant differences for girls or boys in self-reported unprotected first sex, regretted or pressured sex, quality of current sexual relationship, diagnosed sexually transmitted diseases, or ability to identify local sexual health services.
Conclusion
Compared with conventional school sex education at age 13–14 y, this form of peer-led sex education was not associated with change in teenage abortions, but may have led to fewer teenage births and was popular with pupils. It merits consideration within broader teenage pregnancy prevention strategies.
Trial registration:
ISRCTN (ISRCTN94255362).
Judith Stephenson and colleagues report on a cluster randomized trial in London of school-based peer-led sex education and whether it reduced unintended teenage pregnancy.
Editors' Summary
Background.
Teenage pregnancies are fraught with problems. Children born to teenage mothers are often underweight, which can affect their long-term health; young mothers have a high risk of poor mental health after the birth; and teenage parents and their children are at increased risk of living in poverty. Little wonder, then, that faced with one of the highest teenage pregnancy rates in Western Europe, the Department of Health in England launched a national Teenage Pregnancy Strategy in 2000 to reduce teenage pregnancies. The main goal of the strategy is to halve the 1998 under-18 pregnancy rate—there were 46.6 pregnancies for every 1,000 young women in this age group in that year—by 2010. Approaches recommended in the strategy to achieve this goal include the provision of effective sexual health advice services for young people, active engagement of health, social, youth support, and other services in the reduction of teenage pregnancies, and the improvement of sex and relationships education (SRE).
Why Was This Study Done?
Although the annual under-18 pregnancy rate in England is falling, it is still very high, and it is extremely unlikely that the main goal of the Teenage Pregnancy Strategy will be achieved. Experts are, therefore, looking for better ways to reduce both teenage pregnancy rates and the high rates of sexual transmitted diseases among teenagers. Many believe that peer-led SRE—the teaching (sharing) of sexual health information, values, and behaviours by people of a similar age or status group—might be a good approach to try. Peers, they suggest, might convey information about sexual health and relationships better than teachers. However, little is known about the long-term effectiveness of peer-led SRE. In this randomized cluster trial, the researchers compare the effects of a peer-led SRE program and teacher-led sex education given to13- to 14-y-old pupils on abortion and live birth numbers among young women up to age 20 y. In a cluster randomized trial, participants are randomly assigned to the interventions being compared in “clusters”; in this trial, each “cluster” is a school.
What Did the Researchers Do and Find?
Twenty-seven schools in England (about 9,000 13- to 14-y-old pupils) participated in the RIPPLE (Randomized Intervention of PuPil-Led sex Education) trial. Each school was randomly assigned to peer-led SRE (the intervention arm) or to existing teacher-led SRE (the control arm). For peer-led SRE, trained 16- to 17-y-old peer educators gave three 1-h SRE sessions to the younger pupils in their schools. These sessions included practice with condoms, role play to improve sexual negotiating skills, and exercises to improve knowledge about sexual health. The researchers then used routine data on abortions and live births to find out how many female study participants had had an unintended pregnancy before the age of 20 y. One in 20 girls in both study arms had had one or more abortions. Slightly more girls in the control arm than in the intervention arm had had live births, but the difference was small and might have occurred by chance. However, significantly more girls in the intervention arm (11.2%) self-reported a pregnancy by age 18 than in the intervention arm (7.2%). There were no differences between the two arms for girls or boys in any other aspect of sexual health, including sexually transmitted diseases.
What Do These Findings Mean?
These findings indicate that the peer-led SRE program used in this trial had no effect on the number of teenage abortions but may have led to slightly fewer live births among the young women in the study. This particular peer-led SRE program was very short so a more extended program might have had a more marked effect on teenage pregnancy rates; this possibility needs to be tested, particularly since the pupils preferred peer-led SRE to teacher-led SRE. Even though peer-led SRE requires more resources than teacher-led SRE, this form of SRE should probably still be considered as part of a broad teenage prevention strategy, suggest the researchers. But, they warn, their findings should also “temper high expectations about the long-term impact of peer-led approaches” on young people's sexual health.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050224.
This study is further discussed in a PLoS Medicine Perspective by David Ross
Every Child Matters, a Web site produced by the UK government, includes information on teenage pregnancy, the Teenage Pregnancy Strategy, and teenage pregnancy statistics in England
Directgov, an official government Web site for UK citizens, provides advice for parents on talking to children about sex and teenage pregnancyand advice for young people on sexual health and preventing pregnancy
Teachernet, a UK source of online publications for schools, also provides information for parents about sex and relationships education and the UK government's current guidance on SRE in schools
Avert, an international AIDS charity, also provides a fact sheet on sex education
The Sex Education Forum in the UK is the national authority on Sex and Relationships Education
doi:10.1371/journal.pmed.0050224
PMCID: PMC2586352  PMID: 19067478
19.  Effect of pelvic floor muscle exercises on pulmonary function 
Journal of Physical Therapy Science  2015;27(10):3233-3235.
[Purpose] This study aimed to determine the correlation between pelvic floor muscle strength and pulmonary function. In particular, we examined whether pelvic floor muscle exercises can improve pulmonary function. [Subjects] Thirty female college students aged 19–21 with no history of nervous or musculoskeletal system injury were randomly divided into experimental and control groups. [Methods] For the pulmonary function test, spirometry items included forced vital capacity and maximal voluntary ventilation. Pelvic floor muscle exercises consisted of Kegel exercises performed three times daily for 4 weeks. [Results] Kegel exercises performed in the experimental group significantly improved forced vital capacity, forced expiratory volume in 1 second, PER, FEF 25–75%, IC, and maximum voluntary ventilation compared to no improvement in the control group. [Conclusion] Kegel exercises significantly improved pulmonary function. When abdominal pressure increased, pelvic floor muscles performed contraction at the same time. Therefore, we recommend that the use of pelvic floor muscle exercises be considered for improving pulmonary function.
doi:10.1589/jpts.27.3233
PMCID: PMC4668172  PMID: 26644681
Kegel exercise; Forced vital capacity; Maximal voluntary ventilation
20.  A Comparative Study of Whole Body Vibration Training and Pelvic Floor Muscle Training on Women's Stress Urinary Incontinence: Three- Month Follow- Up 
Objective: To determine whether Whole Body Vibration Training (WBVT) is effective at improving pelvic floor muscles strength in women with Stress Urinary Incontinence (SUI).
Materials and methods: The study was designed as a randomized clinical trial. 43 women with SUI were randomly assigned in two groups; WBVT and Pelvic Floor Muscle Training (PFMT) and received interventions for four weeks. Pelvic floor muscle (PFM) strength, quality of life and incontinence intensity were evaluated. All measurements were conducted pre and post intervention and also after 3 months in all participants. The ANOVA and the independent sample t test were applied respectively to determine the differences in each group and between the groups.
Results: This study showed the WBVT protocol in this study was effective in pelvic floor muscles strength similar to PFMT, and also in reducing the severity of incontinence and increasing I-QOL questionnaire score. We found significant differences in each group pre and post intervention (p = 0.0001); but no significant difference in comparison of two groups' outcomes. Also after three-month follow up, there was no significant difference between groups.
Conclusion: The findings of this study showed the beneficial effects of WBVT in improving pelvic floor muscles strength and quality of life in patients with urinary incontinence in four-week treatment period and after three months follow up.
PMCID: PMC4818376  PMID: 27047560
Pelvic Floor Muscle Training; Stress Urinary Incontinence; Whole Body Vibration Training; RCT
21.  Pelvic floor muscle strength of women consulting at the gynecology outpatient clinics and its correlation with sexual dysfunction: A cross-sectional study 
Objective:
To investigate the pelvic floor muscle strength of the women andevaluateits possible correlation with sexual dysfunction.
Methods:
In this cross-sectional type study, stratified clusters were used for the sampling method. Index of Female Sexual Function (IFSF) worksheetwere used for questions on sexual function. The pelvic floor muscle strength of subjects was assessed byperineometer. The chi-squared test, logistic regression and Pearson’s correlation analysis were used for the statistical analysis.
Results:
Four hundred thirty primiparous women, mean age 38.5 participated in this study. The average pelvic floor muscle strength value was found 31.4±9.6 cm H2O and the average Index of Female Sexual Function (IFSF) score was found 26.5±6.9. Parity (odds ratio OR=5.546) and age 40 or higher (OR=3.484) were found correlated with pelvic floor muscle weakness (p<0.05). The factors directly correlated with sexual dysfunction were found being overweight (OR=2.105) and age 40 or higher (OR=2.451) (p<0.05). Pearson’s correlation analysis showed that there was a statistically significantlinear correlation between the muscular strength of the pelvic floor and sexual function (p=0.001).
Conclusion:
The results suggested subjects with decreased pelvic floor muscle strength value had higher frequency of sexual dysfunction.
doi:10.12669/pjms.334.12250
PMCID: PMC5648952
Pelvic floor muscles; Risk factors; Sexual dysfunction
22.  Addressing the sexual problems of Iranian women in a primary health care setting: A quasi-experimental study 
Background:
The World Health Organization emphasizes on integration of sexual health into primary health care services, educating people and health care workers about sexuality, and promoting optimal sexual health. Despite the high prevalence of sexual problems, these problems are poorly managed in primary health care services. This study was conducted to evaluate the efficacy and feasibility of the first two steps of PLISSIT (Permission, Limited Information, Specific Suggestions, Intensive Treatment) model for handling of women sexual problems in a primary health care setting.
Materials and Methods:
This was a quasi-experimental study that was carried out in Zanjan, northwest of Iran. Eighty women who had got married in the past 5 years and had sexual problem were randomly assigned to control and intervention groups. The intervention group received consultation based on PLISSIT model by a trained midwife and the control group received routine services. Female Sexual Function Index (FSFI) questionnaire was used for assessing and tracking any changes in sexual function. Data were collected at three points: Before consultation and 2 and 4 weeks after consultation. Paired t-test and repeated measures analysis of variance (ANOVA) test were used for comparison of scores within groups.
Results:
Significant improvement was found in FSFI sub-domain scores, including sexual desire (P < 0.0001), arousal (P < 0.0001), lubrication (P < 0.0001), orgasm (P = 0.005), satisfaction (P = 0.005), pain (P < 0.0001), and FSFI total score (P < 0.0001) in the intervention group compared to the control group.
Conclusions:
This study showed that PLISSIT model can meet the sexual health needs of clients in a primary health care setting and it can be used easily by health workers in this setting for addressing sexual complaints and dysfunctions.
PMCID: PMC4325406  PMID: 25709703
Iran; primary health care; sexual health; sexual problem
23.  Reduced Pelvic Floor Muscle Tone Predisposes to Persistence of Lower Urinary Tract Symptoms after Puerperium 
Scientifica  2016;2016:5705186.
Pregnant primiparous women at term were enrolled in the study. ICIQ-FLUTS questionnaire was used to find out prevalence of LUTS. MOS was used to assess pelvic floor muscle strength. Women were followed up after 8–10 weeks of delivery to find out remission or persistence of these symptoms. We found that increased frequency of micturition was the most common (82%) LUTS seen in primiparous women at term. More than half (51%) of these women who complained of LUTS had a poor pelvic floor muscle tone (MOS grade 3). Out of those who had symptoms during pregnancy 11% remained symptomatic even after puerperium. Interestingly 61% of those with persistence of symptoms demonstrated a very poor pelvic floor muscle tone at term (MOS grade 2), while the remaining 39% also had a tone of only MOS grade 3. Thus women with LUTS during pregnancy should be screened for their pelvic floor muscle tone with simple MOS system which will help to predict the persistence of these symptoms later on. Women with a low score (three or less) should be triaged for regular pelvic floor muscle exercises.
doi:10.1155/2016/5705186
PMCID: PMC4826944  PMID: 27119044
24.  Behavioural Interventions for Urinary Incontinence in Community-Dwelling Seniors 
Executive Summary
In early August 2007, the Medical Advisory Secretariat began work on the Aging in the Community project, an evidence-based review of the literature surrounding healthy aging in the community. The Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the ministry’s newly released Aging at Home Strategy.
After a broad literature review and consultation with experts, the secretariat identified 4 key areas that strongly predict an elderly person’s transition from independent community living to a long-term care home. Evidence-based analyses have been prepared for each of these 4 areas: falls and fall-related injuries, urinary incontinence, dementia, and social isolation. For the first area, falls and fall-related injuries, an economic model is described in a separate report.
Please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html, to review these titles within the Aging in the Community series.
Aging in the Community: Summary of Evidence-Based Analyses
Prevention of Falls and Fall-Related Injuries in Community-Dwelling Seniors: An Evidence-Based Analysis
Behavioural Interventions for Urinary Incontinence in Community-Dwelling Seniors: An Evidence-Based Analysis
Caregiver- and Patient-Directed Interventions for Dementia: An Evidence-Based Analysis
Social Isolation in Community-Dwelling Seniors: An Evidence-Based Analysis
The Falls/Fractures Economic Model in Ontario Residents Aged 65 Years and Over (FEMOR)
Objective
To assess the effectiveness of behavioural interventions for the treatment and management of urinary incontinence (UI) in community-dwelling seniors.
Clinical Need: Target Population and Condition
Urinary incontinence defined as “the complaint of any involuntary leakage of urine” was identified as 1 of the key predictors in a senior’s transition from independent community living to admission to a long-term care (LTC) home. Urinary incontinence is a health problem that affects a substantial proportion of Ontario’s community-dwelling seniors (and indirectly affects caregivers), impacting their health, functioning, well-being and quality of life. Based on Canadian studies, prevalence estimates range from 9% to 30% for senior men and nearly double from 19% to 55% for senior women. The direct and indirect costs associated with UI are substantial. It is estimated that the total annual costs in Canada are $1.5 billion (Cdn), and that each year a senior living at home will spend $1,000 to $1,500 on incontinence supplies.
Interventions to treat and manage UI can be classified into broad categories which include lifestyle modification, behavioural techniques, medications, devices (e.g., continence pessaries), surgical interventions and adjunctive measures (e.g., absorbent products).
The focus of this review is behavioural interventions, since they are commonly the first line of treatment considered in seniors given that they are the least invasive options with no reported side effects, do not limit future treatment options, and can be applied in combination with other therapies. In addition, many seniors would not be ideal candidates for other types of interventions involving more risk, such as surgical measures.
Note: It is recognized that the terms “senior” and “elderly” carry a range of meanings for different audiences; this report generally uses the former, but the terms are treated here as essentially interchangeable.
Description of Technology/Therapy
Behavioural interventions can be divided into 2 categories according to the target population: caregiver-dependent techniques and patient-directed techniques. Caregiver-dependent techniques (also known as toileting assistance) are targeted at medically complex, frail individuals living at home with the assistance of a caregiver, who tends to be a family member. These seniors may also have cognitive deficits and/or motor deficits. A health care professional trains the senior’s caregiver to deliver an intervention such as prompted voiding, habit retraining, or timed voiding. The health care professional who trains the caregiver is commonly a nurse or a nurse with advanced training in the management of UI, such as a nurse continence advisor (NCA) or a clinical nurse specialist (CNS).
The second category of behavioural interventions consists of patient-directed techniques targeted towards mobile, motivated seniors. Seniors in this population are cognitively able, free from any major physical deficits, and motivated to regain and/or improve their continence. A nurse or a nurse with advanced training in UI management, such as an NCA or CNS, delivers the patient-directed techniques. These are often provided as multicomponent interventions including a combination of bladder training techniques, pelvic floor muscle training (PFMT), education on bladder control strategies, and self-monitoring. Pelvic floor muscle training, defined as a program of repeated pelvic floor muscle contractions taught and supervised by a health care professional, may be employed as part of a multicomponent intervention or in isolation.
Education is a large component of both caregiver-dependent and patient-directed behavioural interventions, and patient and/or caregiver involvement as well as continued practice strongly affect the success of treatment. Incontinence products, which include a large variety of pads and devices for effective containment of urine, may be used in conjunction with behavioural techniques at any point in the patient’s management.
Evidence-Based Analysis Methods
A comprehensive search strategy was used to identify systematic reviews and randomized controlled trials that examined the effectiveness, safety, and cost-effectiveness of caregiver-dependent and patient-directed behavioural interventions for the treatment of UI in community-dwelling seniors (see Appendix 1).
Research Questions
Are caregiver-dependent behavioural interventions effective in improving UI in medically complex, frail community-dwelling seniors with/without cognitive deficits and/or motor deficits?
Are patient-directed behavioural interventions effective in improving UI in mobile, motivated community-dwelling seniors?
Are behavioural interventions delivered by NCAs or CNSs in a clinic setting effective in improving incontinence outcomes in community-dwelling seniors?
Assessment of Quality of Evidence
The quality of the evidence was assessed as high, moderate, low, or very low according to the GRADE methodology and GRADE Working Group. As per GRADE the following definitions apply:
Summary of Findings
Executive Summary Table 1 summarizes the results of the analysis.
The available evidence was limited by considerable variation in study populations and in the type and severity of UI for studies examining both caregiver-directed and patient-directed interventions. The UI literature frequently is limited to reporting subjective outcome measures such as patient observations and symptoms. The primary outcome of interest, admission to a LTC home, was not reported in the UI literature. The number of eligible studies was low, and there were limited data on long-term follow-up.
Summary of Evidence on Behavioural Interventions for the Treatment of Urinary Incontinence in Community-Dwelling Seniors
Prompted voiding
Habit retraining
Timed voiding
Bladder training
PFMT (with or without biofeedback)
Bladder control strategies
Education
Self-monitoring
CI refers to confidence interval; CNS, clinical nurse specialist; NCA, nurse continence advisor; PFMT, pelvic floor muscle training; RCT, randomized controlled trial; WMD, weighted mean difference; UI, urinary incontinence.
Economic Analysis
A budget impact analysis was conducted to forecast costs for caregiver-dependent and patient-directed multicomponent behavioural techniques delivered by NCAs, and PFMT alone delivered by physiotherapists. All costs are reported in 2008 Canadian dollars. Based on epidemiological data, published medical literature and clinical expert opinion, the annual cost of caregiver-dependent behavioural techniques was estimated to be $9.2 M, while the annual costs of patient-directed behavioural techniques delivered by either an NCA or physiotherapist were estimated to be $25.5 M and $36.1 M, respectively. Estimates will vary if the underlying assumptions are changed.
Currently, the province of Ontario absorbs the cost of NCAs (available through the 42 Community Care Access Centres across the province) in the home setting. The 2007 Incontinence Care in the Community Report estimated that the total cost being absorbed by the public system of providing continence care in the home is $19.5 M in Ontario. This cost estimate included resources such as personnel, communication with physicians, record keeping and product costs. Clinic costs were not included in this estimation because currently these come out of the global budget of the respective hospital and very few continence clinics actually exist in the province. The budget impact analysis factored in a cost for the clinic setting, assuming that the public system would absorb the cost with this new model of community care.
Considerations for Ontario Health System
An expert panel on aging in the community met on 3 occasions from January to May 2008, and in part, discussed treatment of UI in seniors in Ontario with a focus on caregiver-dependent and patient-directed behavioural interventions. In particular, the panel discussed how treatment for UI is made available to seniors in Ontario and who provides the service. Some of the major themes arising from the discussions included:
Services/interventions that currently exist in Ontario offering behavioural interventions to treat UI are not consistent. There is a lack of consistency in how seniors access services for treatment of UI, who manages patients and what treatment patients receive.
Help-seeking behaviours are important to consider when designing optimal service delivery methods.
There is considerable social stigma associated with UI and therefore there is a need for public education and an awareness campaign.
The cost of incontinent supplies and the availability of NCAs were highlighted.
Conclusions
There is moderate-quality evidence that the following interventions are effective in improving UI in mobile motivated seniors:
Multicomponent behavioural interventions including a combination of bladder training techniques, PFMT (with or without biofeedback), education on bladder control strategies and self-monitoring techniques.
Pelvic floor muscle training alone.
There is moderate quality evidence that when behavioural interventions are led by NCAs or CNSs in a clinic setting, they are effective in improving UI in seniors.
There is limited low-quality evidence that prompted voiding may be effective in medically complex, frail seniors with motivated caregivers.
There is insufficient evidence for the following interventions in medically complex, frail seniors with motivated caregivers:
habit retraining, and
timed voiding.
PMCID: PMC3377527  PMID: 23074508
25.  An Intervention to Reduce HIV Risk Behavior of Substance-Using Men Who Have Sex with Men: A Two-Group Randomized Trial with a Nonrandomized Third Group 
PLoS Medicine  2010;7(8):e1000329.
In a randomized trial of a behavioral intervention among substance-using men who have sex with men, aimed at reducing sexual risk behavior, Mansergh and colleagues fail to find evidence of a reduction in risk from the intervention.
Background
Substance use during sex is associated with sexual risk behavior among men who have sex with men (MSM), and MSM continue to be the group at highest risk for incident HIV in the United States. The objective of this study is to test the efficacy of a group-based, cognitive-behavioral intervention to reduce risk behavior of substance-using MSM, compared to a randomized attention-control group and a nonrandomized standard HIV-testing group.
Methods and Findings
Participants (n = 1,686) were enrolled in Chicago, Los Angeles, New York City, and San Francisco and randomized to a cognitive-behavioral intervention or attention-control comparison. The nonrandomized group received standard HIV counseling and testing. Intervention group participants received six 2-h group sessions focused on reducing substance use and sexual risk behavior. Attention-control group participants received six 2-h group sessions of videos and discussion of MSM community issues unrelated to substance use, sexual risk, and HIV/AIDS. All three groups received HIV counseling and testing at baseline. The sample reported high-risk behavior during the past 3 mo prior to their baseline visit: 67% reported unprotected anal sex, and 77% reported substance use during their most recent anal sex encounter with a nonprimary partner. The three groups significantly (p<0.05) reduced risk behavior (e.g., unprotected anal sex reduced by 32% at 12-mo follow-up), but were not different (p>0.05) from each other at 3-, 6-, and 12-mo follow-up. Outcomes for the 2-arm comparisons were not significantly different at 12-mo follow-up (e.g., unprotected anal sex, odds ratio = 1.14, confidence interval = 0.86–1.51), nor at earlier time points. Similar results were found for each outcome variable in both 2- and 3-arm comparisons.
Conclusions
These results for reducing sexual risk behavior of substance-using MSM are consistent with results of intervention trials for other populations, which collectively suggest critical challenges for the field of HIV behavioral interventions. Several mechanisms may contribute to statistically indistinguishable reductions in risk outcomes by trial group. More explicit debate is needed in the behavioral intervention field about appropriate scientific designs and methods. As HIV prevention increasingly competes for behavior-change attention alongside other “chronic” diseases and mental health issues, new approaches may better resonate with at-risk groups.
Trial Registration
ClinicalTrials.gov NCT00153361
Please see later in the article for the Editors' Summary
Editors' Summary
Background
AIDS first emerged in the early 1980s among gay men living in the US. As the disease spread around the world, it became clear that AIDS also affects heterosexual men and women. Now, three decades on, more than 30 million people are infected with HIV, the virus that causes AIDS. HIV is most often spread by having unprotected sex with an infected partner and, globally, most sexual transmission of HIV now occurs during heterosexual sex. However, 5%–10% of all new HIV infections still occur in men who have sex with men (MSM, a term that encompasses gay, bisexual, transgendered, and heterosexual men who sometimes have sex with men) and, in several high-income countries, male-to-male sexual contact remains the most important HIV transmission route. In the US, for example, more than half of the approximately 50,000 people who become infected with HIV every year do so through male-to-male sexual contact.
Why Was This Study Done?
In countries where MSM are the group at highest risk of HIV infection, any intervention that reduces HIV transmission in MSM should have a major effect on the overall HIV infection rate. Among MSM, sexual behaviors that increase the risk of HIV infection (for example, not using a condom, having anal sex, having sex with a partner of unknown HIV status, and having sex with many partners) are associated with the use of alcohol and noninjection drugs (for example, inhaled amyl nitrite or poppers) during or shortly before sexual encounters. In this study (Project MIX), the researchers investigate whether a group-based behavioral intervention reduces sexual risk behavior in substance-using MSM.
What Did the Researchers Do and Find?
The researchers recruited substance-using MSM from four US cities who had had risky sex at least once in the past 6 months. Participants were randomized to a cognitive-behavioral intervention or to an attention-control group; a third, nonrandomized group of MSM formed a standard HIV counseling and testing only group. All the groups had HIV counseling and testing at the start of the study and completed a questionnaire about their substance use and sexual risk behavior during their most recent anal sex encounter. The cognitive-behavior group then received six weekly 2-hour group sessions focused on reducing substance use and sexual risk behavior by helping the men change their thinking (cognition) and behavior regarding sexual risk taking. The attention-control group received six group sessions about general MSM issues such as relationships, excluding discussion of substance use, and sexual risk behavior. The participants in both of these groups completed the questionnaire about their substance use and sexual risk behavior again at 3, 6, and 12 months after the group sessions; the participants in the standard HIV counseling and testing group completed the questionnaire again about 5 months after completing the first questionnaire (to control for the time taken by the other two groups to complete the intervention). At baseline, about 67% of the participants reported unprotected anal sex and 77% reported substance use during their most recent anal sex encounter with a nonprimary partner. At the 3-month follow-up, the incidence of sexual risk behavior had fallen to about 43% in all three groups; the incidence of substance use during sex had fallen to about 50%. Risk taking and substance use remained at these levels in the intervention and attention-control groups at the later follow-up time points.
What Do These Findings Mean?
These findings suggest that this cognitive-behavioral intervention is no better at reducing sexual risk taking among substance-using MSM than is an unrelated video-discussion group or standard HIV counseling and testing. One explanation for this negative result might be that brief counseling is especially effective with people who are ready for a change such as MSM willing to enroll in an intervention trial of this type. Alternatively, just being in the trial might have encouraged all the participants to self-report reduced risk behavior. Thus, alternative scientific designs and methods might be needed to find behavioral interventions that can effectively reduce HIV transmission among substance-using MSM and other people at high risk of HIV infection. Importantly, however, these findings raise the question of whether more extensive, multilevel interventions or broader lifestyle and positive health approaches (rather than single-level or single-subject behavioral interventions) might be needed to reduce sexual risk behavior among substance-using MSM.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000329.
Information is available from the US Department of Health and Human Services on HIV prevention programs, research, and policy
Information is available from the US National Institute of Allergy and Infectious Diseases on HIV infection and AIDS
HIV InSite has comprehensive information on all aspects of HIV/AIDS, including information on HIV transmission and transmission in gay men and other MSM, on substance abuse and HIV/AIDS, and on safer sex
Information is available from Avert, an international AIDS nonprofit, on all aspects of HIV/AIDS, including information on HIV, AIDS, and men who have sex with men and on drink, drugs, and sex (in English and Spanish)
The US Centers for Disease Control and Prevention also have information for the public and for professionals about HIV/AIDS among men who have sex with men (in English and Spanish)
The US National Institute on Drug Abuse has information on HIV/AIDS and drug abuse, including a resource aimed at educating teenagers about the link between drug abuse and the spread of HIV in the US (in English and Spanish)
doi:10.1371/journal.pmed.1000329
PMCID: PMC2927550  PMID: 20811491

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