Little is known about women’s experience with conservative management of pelvic organ prolapse. We sought to understand the experiences of Spanish-speaking women who choose a pessary.
Spanish-speaking women from a urogynecologic pessary clinic were recruited for this study. Interviews were conducted and the women were asked about their pessary experience including questions involving symptom relief, pessary management, and quality of life. All interview transcripts were analyzed using the qualitative methods of Grounded Theory.
Sixteen Spanish-speaking women who had been using a pessary for at least one month were enrolled in this study. Grounded theory methodology yielded several preliminary themes, in which one major concept emerged as a pessary adjustment process. In this process patients had to first decide to use a pessary, either because of physician’s recommendations or out of personal choice. Second, the patients entered an adjustment period in which they learned to adapt to the pessary, both physically and mentally. Lastly, if the patients properly adjusted to wearing a pessary they experienced relief of bothersome symptoms.
Our findings demonstrate that Spanish-speaking women go through a process in order to adjust to a pessary. Furthermore, the physician has a major role in not only determining a woman’s decision to use a pessary, but also whether she can adjust to wearing the pessary. This process is most successful when patients receive comprehensive management from a healthcare team of physicians and nurses who can provide individualized and continuous pessary care.
Latina; pelvic organ prolapse; pessary; Spanish-speaking
To describe the development, feasibility and validity of a wireless intra-vaginal pressure transducer (IVT) which can be used to measure intra-abdominal pressure in real-world settings.
A feasibility study was conducted in sixteen physically active women to determine retention and comfort of various IVT prototype designs during activity. A criterion validity study was conducted among women undergoing urodynamic testing to determine the accuracy of the IVT prototypes when compared to accepted clinical standards.
A final prototype wireless IVT was developed after four design revisions of the second generation model. The feasibility study found that women reported the final prototype comfortable to wear and easily retained during physical activity. Intra-abdominal pressure measurements from the final prototype IVT compared favorably to standard urodynamic transducers, thus confirming evidence of its utility.
We have successfully advanced the design of a wireless, intra-vaginal pressure transducer which provides accurate measures of intra-abdominal pressure. The final wireless IVT is better tolerated by patients and overcomes limitations of traditional urodynamic testing while laying the foundations for intra-abdominal pressure monitoring outside of the clinic environment.
Wireless intravaginal pressure transducer; intra-abdominal pressure; pelvic organ prolapse
Introduction and hypothesis This study aims to measure self-report urinary incontinence questions' reproducibility and agreement with bladder diary.
Methods Data were analyzed from the Reproductive Risk of Incontinence Study at Kaiser. Participating women reporting at least weekly incontinence completed self-report incontinence questions and a 7-day bladder diary. Self-report question reproducibility was assessed and agreement between self-reported and diary-recorded voiding and incontinence frequency was measured. Test characteristics and area under the curve were calculated for self-reported incontinence types using diary as the gold standard.
Results Five hundred ninety-one women were included and 425 completed a diary. The self-report questions had moderate reproducibility and self-reported and diary-recorded incontinence and voiding frequencies had moderate to good agreement. Self-reported incontinence types identified stress and urgency incontinence more accurately than mixed incontinence.
Conclusions Self-report incontinence questions have moderate reproducibility and agreement with diary, and considering their minimal burden, are acceptable research tools in epidemiologic studies.
Reproducibility of results; Sensitivity and specificity; Stress urinary incontinence; Urinary incontinence, classification; Urgency urinary incontinence
To characterize pelvic floor symptoms in post-menopausal women who had undergone osteoporosis evaluation, and examine their association with bone mineral density (BMD).
Pelvic floor symptom questionnaires were mailed to 4,026 women. Multivariable logistic regression models controlling for age, race, body mass index, and chronic obstructive pulmonary disease were performed comparing symptoms in women with osteoporosis (T-score: ≤−2.5) and osteopenia (T-score: >−2.5 to <−1) at any site to women with normal BMD (T-score: ≥−1, referent).
1774/4026 (44%) questionnaires were returned; 1655 were included in the analysis (362 osteoporosis, 870 osteopenia, 423 normal BMD). Overall prevalence of any urinary incontinence (UI) was 1226/1640 (75%), with UI ≥2–3 times/week in 699/1197 (58%), fecal incontinence over the past month in 247/1549 (16%), and prolapse in 162/1582 (10%). Multivariable analyses revealed that women with osteopenia had increased risk of incontinence of solid stool (aOR:1.7, 95% CI:1.1–2.4). Risk of UI ≥2–3 times/week was not increased in women with osteoporosis (aOR:0.9, CI:0.6, 1.3) and was lower in women with osteopenia (aOR:0.7, CI:0.5, 0.9). In women with osteoporosis, the odds of moderate/large-volume urine loss versus small/none was higher for those in the lower T-score quartile (lower BMD; aOR:1.43, CI:1.1, 1.9).
In women undergoing osteoporosis evaluation, those with osteopenia were at increased risk of fecal incontinence, but not UI compared to normal women. Osteoporotic women with the lowest T-scores had higher risk of moderate/large volume UI. It is unclear whether there is a pathophysiologic link between BMD loss and development of pelvic floor symptoms.
pelvic floor disorders; bone mineral density; pathophysiology
Introduction and Hypothesis
Weight-loss has been demonstrated to result in an improvement in fecal incontinence (FI) severity; however, there is a paucity of data addressing differential impact of FI on quality of life (QOL) and results of diagnostic testing across BMI categories. We wished to evaluate symptom distress, QOL, and diagnostic testing parameters among normal, overweight, and obese women with fecal incontinence.
Women undergoing evaluation for FI between 2003 and 2012 were identified. Participants completed validated, symptom specific distress, impact, and general QOL measures including the Modified Manchester Questionnaire (MMHQ) which includes the Fecal Incontinence Severity Index (FISI), and the mental and physical component summary scores, MCS and PCS, respectively of the Short Form-12. Anorectal manometry measures were also included. Multivariable regression analyses were performed.
Participants included 407 women with a mean age ± SD of 56 ± 13. Multivariable analyses revealed no differences in symptom specific distress and impact as measured by MMHQ, MCS and PCS across BMI groups, however, obese women had increased resting and squeeze pressures compared to normal and overweight BMI women (p<0.0001and p<0.0001; p = 0.007 and p = 0.004, respectively).
Obese women with FI did not have more general impact and symptom-specific distress and impact on quality of life as compared to normal and overweight women. Obese women with FI had higher baseline anal resting and squeeze pressures suggesting a lower threshold to leakage with pressure increases.
anal manometry; fecal incontinence; obesity; quality of life; symptom distress
Introduction and Hypothesis
Two-dimensional magnetic resonance imaging (MRI) of posterior vaginal prolapse has been studied. However, the three-dimensional (3-D) mechanisms causing such prolapse remain poorly understood. This discovery project was undertaken to identify the different 3-D characteristics of models of rectocele-type posterior vaginal prolapse (PVPR) in women.
Ten women with (cases) and 10 without (controls) PVPR were selected from an ongoing case-control study. Supine, multi-planar MR imaging was performed at rest and maximal Valsalva. 3-D reconstructions of the posterior vaginal wall and pelvic bones were created using 3D Slicer v. 3.4.1. In each slice the posterior vaginal wall and perineal skin were outlined to the anterior margin of the external anal sphincter to include the area of the perineal body. Women with predominant enteroceles or anterior vaginal prolapse were excluded.
The case and control groups had similar demographics. In women with PVPR two characteristics were consistently visible (10 of 10): 1) the posterior vaginal wall displayed a folding phenomenon similar to a person beginning to kneel (“Kneeling” shape); and 2) a downward displacement in the upper 2/3 of the vagina. Also seen in some, but not all of the scans were: 3) forward protrusion of the distal vagina (6 of 10); 4) perineal descent (5 of 10); and 5) distal widening in lower third of the vagina (3 of 10).
Increased folding (“Kneeling”) of the vagina and an overall downward displacement are consistently present in rectocele. Forward protrusion, perineal descent and distal widening are sometimes seen as well.
posterior vaginal wall prolapse; pelvic organ prolapse; rectocele; 3D model; magnetic resonance imaging; anatomy
Introduction and hypothesis
To determine whether fecal incontinence (FI) is associated with sexual activity and to compare sexual function in women with and without FI.
We conducted a retrospective chart review of all new patients seen in an academic urogynecology clinic. Women who reported fecal incontinence, as defined by loss of fecal material on the Wexner scale, were compared with those without fecal incontinence. We compared sexual activity and Pelvic Organ Prolapse Incontinence Sexual Questionnaire-12 (PISQ-12) scores between groups.
In our population of women with pelvic floor disorder, 588 women reported FI compared with 527 who did not. On multivariate analysis, FI was not associated with sexual activity status, but was associated with worsened PISQ-12 scores (p<0.001). PISQ-12 item analysis found that women with FI reported more dyspareunia, fear, and avoidance of sexual activity with greater partner problems (all p <0.05) than women without FI.
Women with FI were as likely to engage in sexual relations as women without FI; however, sexually active women with FI had poorer sexual function than those without FI.
Fecal incontinence; Sexual activity; Sexual function
Introduction and Hypothesis
It is commonly believed that pelvic organ prolapse is associated with cervical elongation. However, cervical lengths have not been formally compared between women with prolapse and those with normal support.
Cervix and uterine corpus lengths were measured on magnetic resonance images in a case-control study of 51 women with prolapse and 46 women with normal support determined by pelvic organ prolapse (POP) quantification (POP-Q) examination. Group matching ensured similar demographics in both groups. Ranges for normal cervical lengths were determined from the values in the control group in order to evaluate for cervical elongation amongst women with prolapse.
The cervix is 36.4% (8.6 mm) longer in women with prolapse than in women with normal pelvic support (p < 0.001). Linear regression modeling suggests the feature most highly associated with cervical length is the degree of uterine descent (POP-Q point C). Approximately 40% of women with prolapse have cervical elongation. 57% of cervical elongation in prolapse can be explained by a logistic-regression based model including POP-Q point C, body mass index and menopausal status.
Cervical elongation is found in one-third of women with pelvic organ prolapse, with the extent of elongation increasing with greater degrees of uterine descent.
Cervical elongation; Pelvic organ prolapse; Magnetic resonance imaging
Introduction and hypothesis
To estimate distances from the mid-urethra to the obturator foramina and to explore correlations between pelvic dimensions and body height.
This is a secondary analysis of a parent case–control study on the mechanisms of stress urinary incontinence. We measured pelvic dimensions on magnetic resonance images of women with (cases, n=50) and without (controls, n=50) stress urinary incontinence.
The mean distance from mid-urethra to the obturator membrane among cases is 31.8 mm (left) and 32.1 mm (right), with a range from 25.9 to 42.0 mm. There were no significant differences in these distances when comparing left with right, or cases with controls. Weak correlation was found between the urethra-to-obturator foramina distances and heights only in the case subjects.
There is high variability in the distance from mid-urethra to the obturator foramina. Height should not be used as a predictor of dimensions in the lesser pelvis.
Anatomy; Female; Obturator foramen; Stress urinary incontinence; Transobturator tape; MRI
Introduction and hypothesis
The objective of this study was to compare complementary and alternative medicine (CAM) use in women with and without pelvic floor disorders (PFD).
We conducted a survey of women presenting to a specialty urogynecology (Urogyn) and gynecology (Gyn) clinic that examined demographic data, CAM use, and the presence of PFD (validated questionnaires). T tests, Fisher’s exact tests, and logistic regression were used for analysis. To detect a 20% difference between groups, 234 Urogyn and 103 Gyn patients were needed.
Participants included 234 Urogyn and 103 Gyn patients. Urogyn patients reported more CAM use than Gyn patients, even when controlled for differences between groups (51% vs. 32%, adjusted p=0.006). Previous treatment (61% vs. 39%, adjusted p<0.001) and increased number of PFD was associated with increased CAM use (adjusted p=0.02).
Women with PFD use CAM more frequently than women without PFD.
Complementary alternative medicine; Fecal incontinence; Pelvic floor disorders; Pelvic organ prolapse; Urinary incontinence
Intorduction and hypothesis
To understand the patient burden of study procedures/measures at completion of a randomized controlled trial (RCT) requiring extensive testing and follow-up visits.
A survey sent after completing the 2 year visit of an RCT comparing Burch colposuspension and fascial retropubic sling to treat stress urinary incontinence assessed degree of bother for seven study procedures, eight study-related factors, and possible motivations to participate in the study.
A total of 450 study participants (88%) returned the survey. Urodynamic testing was the most bothersome procedure, followed by 24 hour pad test and Q-tip test. Self-administered questionnaires were the least bothersome. Main reasons to participate in the study were to help others, obtain better knowledge about the condition, and be guided by a committed team of investigators/study coordinators.
At the end of a large multicenter RCT, we learned from a confidential patient survey that the most burdensome activities involved invasive procedures, frequent visits, and multiple forms to fill out.
outcome measures; patient survey; stress incontinence
Vitamin D is a micronutrient vital in calcium homeostasis and musculoskeletal health. Vitamin D insufficiency is a common variant of vitamin D deficiency which has clinical signs of rickets and osteomalacia. The clinical significance of vitamin D insufficiency is being explored in several medical conditions. However, the most robust work suggests a role in musculoskeletal disease. The pelvic floor is a unique part of the body whose function is dependent on interrelationships between muscle, nerve, connective tissue, and bone. Pelvic floor disorders result when these relationships are disrupted. This paper reviews current knowledge regarding insufficient vitamin D nutritional status, the importance of vitamin D in muscle function, and how insufficient or deficient vitamin D levels may play a role in the function of the female pelvic floor.
pelvic floor disorders; urinary incontinence; vitamin D
Over 10 years have passed since the first US National Institutes of Health consensus panel considered standardization of definitions of pelvic floor conditions and criteria utilized for reporting pelvic floor research study outcomes. The literature is replete with pelvic floor outcome studies; however, a consistent standardized approach to the evaluation of patients and characterization of outcomes is still needed. The purpose of this overview is to describe how the use of outcome measures have evolved over time and attempt to help readers utilize the best measures for their clinical and research needs.
pelvic floor disorder research; urogynecology surgical outcomes
To characterize the relationship between 25-hydroxyvitamin D [25(OH)D] status with pelvic floor symptom distress and impact on quality of life.
A retrospective chart review was performed in women with a 25(OH)D level drawn within one year of their Gynecology/Urogynecology visit. Validated questionnaires including the Colorectal Anal Distress Inventory (CRADI)-8 and Incontinence Impact Questionnaire (IIQ-7) were used. Multivariate analyses characterized PFD symptom differences among women by vitamin D status.
394 women were included. Mean±SD 25(OH)D levels were higher in women without PFD symptoms [35.0±14.1 and 29.3±11.5 (ng/ml), respectively (p<0.001)]. The prevalence of vitamin D insufficiency was 51% (136/268). CRADI-8 scores and IIQ-7 scores were higher among women with vitamin D insufficiency (p=0.03 and p=0.001, respectively). Higher IIQ-7 scores were independently associated with vitamin D insufficiency (p<0.001).
Insufficient vitamin D is associated with increased colorectal symptom distress and greater impact of urinary incontinence on quality of life.
vitamin D; urinary incontinence; women; pelvic floor disorders
Introduction and hypothesis
Bladder pain syndrome/interstitial cystitis (BPS/IC) is identified based on subjective symptoms which lead to heterogeneous patient populations. Previous studies using gene expression arrays for BPS/IC with Hunner’s lesions [European Society for the Study of Interstitial Cystitis (ESSIC) type 3C], a subtype of the condition discernible by cystoscopy, have revealed characteristic immune responses and urothelial abnormalities. This current study aimed to further characterize this subtype using a gene expression panel. We hypothesized that B-cell activation with high levels of urinary antibody concentration would be found.
Cold-cup bladder biopsies, catheterized urine and blood were collected from 15 BPS/IC ESSIC type 3C patients, 11 non-inflammatory overactive bladder (OAB) patients and eight healthy controls. Gene expression in biopsies was quantified by real-time quantitative polymerase chain reaction (RT-qPCR), immunohistochemistry was performed on bladder tissue and urinary immunoglobulins G and A were quantified by enzyme-linked immunosorbent assay. Statistical analyses included the Kruskal-Wallis test for non-parametric data and post hoc tests identified differences between groups.
High expression of T- and B-cell markers (CTLA4, CD20, CD79A, IGH@), low expression of urothelial markers (KRT20, UPK1B, UPK3A), focal lymphoid aggregates in the submucosa and high immunoglobulin concentration in urine were found exclusively in BPS/IC ESSIC type 3C patients. Results for OAB were in intermediate ranges between the other two groups and UPK1B even reached significantly lower expression when compared to healthy controls.
BPS/IC ESSIC type 3C is characterized by a local adaptive immune response with elevated urinary antibody concentrations. Quantification of urinary immunoglobulin levels could be used for a non-invasive diagnosis of BPS/IC ESSIC type 3C.
Bladder pain syndrome/interstitial cystitis; Diagnostic markers; Immune response; Overactive bladder; Urothelium
Introduction and Hypothesis
Recently, numerous Type I macroporous polypropylene vaginal meshes have been introduced into the market with little known of their differences.
Seven vaginal meshes were obtained and loaded to failure (N=5/type). Additional cyclic loading determined permanent deformation with submaximal loading.
The load-elongation curves demonstrated a bilinear response with lower stiffness (N/mm), followed by higher stiffness. Ascend™ was the stiffest mesh in both regions of the load-elongation curve (0.72 N/mm, 1.66 N/mm) with the lowest transition to higher stiffness (13.4%). Polyform™ had the highest failure load (53.8 N) while Ultrapro™ had the lowest (7.83 N). Novasilk™ (89.4%) and Ultrapro™ (87.9%) had the highest relative elongations at mesh failure while Ascend™ had the lowest (40.2%). Ascend™ had the least relative elongation after 3 protocols of cyclic loading (3.0%, 9.8%, 9.7%).
Current vaginal meshes demonstrate marked variation in biomechanical characteristics which may impact their in vivo behavior.
Pelvic Organ Prolapse; Polypropylene Mesh; Prolapse; Mesh; Vaginal Mesh; Vaginal Reconstructive Surgery
Introduction and hypothesis
The aim of the study was to compare the efficacy and safety of transvaginal trocar-guided polypropylene mesh insertion with traditional colporrhaphy for treatment of anterior vaginal wall prolapse.
This is a randomized controlled trial in which women with advanced anterior vaginal wall prolapse, at least stage II with Ba ≥ +1 cm according to the Pelvic Organ Prolapse Quantification (POP-Q) classification, were randomly assigned to have either anterior colporrhaphy (n = 39) or repair using trocar-guided transvaginal mesh (n = 40). The primary outcome was objective cure rate of the anterior compartment (point Ba) assessed at the 12-month follow-up visit, with stages 0 and I defined as anatomical success. Secondary outcomes included quantification of other vaginal compartments (POP-Q points), comparison of quality of life by the prolapse quality of life (P-QOL) questionnaire, and complication rate between the groups after 1 year. Study power was fixed as 80 % with 5 % cutoff point (p < 0.05) for statistical significance.
The groups were similar regarding demographic and clinical preoperative parameters. Anatomical success rates for colporrhaphy and repair with mesh placement groups were 56.4 vs 82.5 % (95 % confidence interval 0.068–0.54), respectively, and the difference between the groups was statistically significant (p = 0.018). Similar total complication rates were observed in both groups, with tape exposure observed in 5 % of the patients. There was a significant improvement in all P-QOL domains as a result of both procedures (p < 0.001), but they were not distinct between groups (p > 0.05).
Trocar-guided transvaginal synthetic mesh for advanced anterior POP repair is associated with a higher anatomical success rate for the anterior compartment compared with traditional colporrhaphy. Quality of life equally improved after both techniques. However, the trial failed to detect differences in P-QOL scores and complication rates between the groups.
Colporrhaphy; Mesh; Pelvic organ prolapse; POP surgery; Anterior vaginal wall; Nazca TC™
Utilize focus group methodology to gather information about women’s knowledge and attitudes regarding research participation.
Two in-person focus groups at 7 clinical sites were conducted, one composed of women with pelvic floor disorder (PFD) clinical trial study-experience; the other was composed of PFD clinical trial study-naïve participants. One web-based focus group that combined groups was also conducted.
105 women (average age 58.6 years) participated. Participants in both groups believed that their physicians were the best source of information about clinical trials, yet felt that other sources of trial information were important. Financial compensation was not a primary motivating factor for PFD trial enrollment, however was cited as an important consideration. Internet- collection of data was feasible and provided information comparable to in-person focus groups.
This study identified central themes guiding successful recruitment to and retention in PFD-related trials providing insight regarding strategies that may guide future trials.
Research; Focus Group; Web focus group; Pelvic Floor Disorders; Incentives
To characterize trends in lower reproductive tract fistula (LRTF) repair in inpatient US women from 1979-2006.
Retrospective data was obtained from the National Hospital Discharge Survey regarding LRTF diagnoses, demographics, comorbidities, and fistula repair procedures, using ICD-9-CM diagnostic and procedure codes. Age-adjusted rates (AARs) were calculated using 1990 census data. Trends in LRTF surgical repair were evaluated using regression analysis.
Between 1979 and 2006, the AAR of LRTF repair declined from 7.8 to 4.8 per 100,000 women (b = −2.97, p<0.001). The most common surgical fistula repairs were rectovaginal, vesicovaginal, and colovaginal. The AARs of colovaginal and vesicovaginal fistula repair remained stable, while the AAR of rectovaginal fistula repair declined.
The AAR of inpatient LRTF repair declined between 1979 and 2006, perhaps reflecting a concurrent decrease in obstetric trauma, in the context of decreasing episiotomy and operative vaginal delivery and increasing Cesarean section rates.
colovaginal fistula; hospital discharge data; rectovaginal fistula; surgical repair; vesicovaginal fistula
Introduction and hypothesis
Little is known about dynamic cell-matrix interactions in the context of pathophysiology and treatments for pelvic organ prolapse (POP). This study sought to identify differences between fibroblasts from women with varying degrees of prolapse in reaction to mechanical stimuli and matrix substrates in vitro.
Fibroblasts from the vaginal wall of three patients with POP Quantification (POP-Q) system stages 0, II, and IV were stretched on artificial polymer substrates either coated or not coated with collagen I. Changes in morphology and anabolic/catabolic compounds that affect matrix remodelling were evaluated at protein- and gene-expression levels. Statistical analysis was performed using one-way analysis of variance (ANOVA), followed by Tukey-Kramer’s post hoc test.
POP fibroblasts show delayed cell alignment and lower responses to extracellular matrix remodelling factors at both enzymatic- and gene-expression levels compared with healthy fibroblasts.
POP fibroblasts, when compared with healthy cells, show differential mechanoresponses on two artificial polymer substrates. This should be taken into account when designing or improving implants for treating POP.
Cyclic mechanical loading; Matrix metalloproteinase-2; Pelvic organ prolapse; Surface substrates; Tissue inhibitor of metalloproteinase-2; Vaginal fibroblasts
Introduction and hypothesis
Vaginal tactile imaging (VTI) is based on principles similar to those of manual palpation. The objective of this study is to assess the clinical suitability of new approach for imaging and tissue elasticity quantification under normal and prolapse conditions.
The study subjects included 31 women with normal and prolapse conditions. The tissue elasticity (Young’s modulus) was calculated from spatial gradients in the resulting 3-D tactile images.
Average values for tissue elasticity for the anterior and posterior compartments for normal conditions were 7.4±4.3 kPa and 6.2±3.1 kPa respectively. For Stage III prolapse the average values for tissue elasticity for anterior and posterior compartments were 1.8±0.7 kPa and 1.8±0.5 kPa respectively.
VTI may serve as a means for 3-D imaging of the vagina and a quantitative assessment of vaginal tissue elasticity, providing important information for furthering our understanding of pelvic organ prolapse and surgical treatment.
Biomechanical properties; Elasticity; Prolapse; Vaginal tissue; Tactile imaging
This study assesses relative contributions of "midline defects" (widening of the vagina) and "paravaginal defects" (separation of the lateral vagina from the pelvic sidewall).
Ten women with anterior predominant prolapse and 10 with normal support underwent pelvic MR imaging. 3-D models of the anterior vaginal wall (AVW) were generated to determine locations of the lateral AVW margin, vaginal width, and apical position.
The lateral AVW margin was farther from its normal position in cases than controls throughout most of the vaginal length, most pronounced midvagina (effect sizes 2.2–2.8). Vaginal widths differed in the midvagina with an effect size of 1.0. Strong correlations between apical and paravaginal support were evident in mid and upper vagina (r=0.77–0.93).
Changes in lateral AVW location were considerably greater than changes in vaginal width in cases vs controls, both in number of sites affected and effect sizes. These "paravaginal defects" are highly correlated with apical descent.
cystocele; paravaginal defect; midline defect; anterior wall prolapse; pelvic organ prolapse; MR imaging
Introduction and hypothesis
Mirabegron is a potent and selective β3-adrenoceptor agonist that may represent an alternative treatment option in place of antimuscarinics for patients with overactive bladder.
Patients completed a single-blinded, 2-week placebo run-in period followed by 12 weeks of randomized (n = 928) double-blinded treatment with mirabegron oral controlled absorption system (OCAS) 25, 50, 100, or 200 mg once-daily (QD), placebo or tolterodine extended release (ER) 4 mg QD. The primary endpoint was change from baseline to end-of-treatment in mean number of micturition episodes/24 h. Secondary endpoints included changes in mean volume voided per micturition; mean number of urinary incontinence, urgency urinary incontinence, and urgency episodes/24 h; severity of urgency; nocturia; and quality of life measures. Safety parameters included vital signs, adverse events, laboratory tests, electrocardiogram measurements and post-void residual volume.
Mirabegron 25, 50, 100, and 200 mg resulted in dose-dependent reductions (improvements) from baseline to end-of-treatment in micturition frequency of 1.9, 2.1, 2.1, and 2.2 micturitions/24 h respectively, versus 1.4 micturitions/24 h with placebo (p ≤ 0.05 for the mirabegron 50-, 100-, and 200-mg comparisons). There was a statistically significant improvement with mirabegron compared with placebo for most secondary endpoints including quality of life variables. While there was a significant (p < 0.05) increase from baseline in pulse rate in the mirabegron 100-mg and 200-mg groups, this was not associated with an increased incidence of cardiovascular adverse events.
The favorable efficacy and tolerability of mirabegron in this phase II dose-finding study has led to its successful advancement into a phase III clinical development program.
β3-adrenoceptor agonist; Mirabegron; Overactive; Urinary bladder
Introduction and hypothesis
The aim of this study was to evaluate the results of conservative treatment of urodynamic stress urinary incontinence (SUI) using transvaginal electrical stimulation with surface-electromyography-assisted biofeedback (TVES + sEMG) in women of premenopausal age.
One hundred and two patients with SUI were divided into two groups: active (n = 68) and placebo (n = 34) TVES + sEMG. The treatment lasted for 8 weeks and consisted of two sessions per day. Women were evaluated before and after the intervention by pad test, voiding diary, urodynamic test, and the Incontinence Quality of Life Questionnaire (I-QOL).
Mean urinary leakage on a standard pad test at the end of 8th week was significantly lower in the active than the placebo group (19.5 ± 13.6 vs. 39.8 ± 28.5). Mean urinary leakage on a 24-h pad test was significantly reduced in the active group at the end of 8th and 16th weeks compared with the placebo group (8.2 ± 14.8 vs. 14.6 ± 18.9 and 6.1 ± 11.4 vs. 18.2 ± 20.8, respectively). There was also a significant improvement in muscle strength as measured by the Oxford scale in the active vs the placebo group after 8 and 16 weeks (4.2 vs 2.6 and 4.1 vs 2.7, respectively). No significant difference was found between groups in urodynamic data before and after treatment. At the end of 8th week, the mean I-QOL score in the active vs the placebo group was 78.2 ± 17.9 vs 55.9 ± 14.2, respectively, and at the end of 16th week 80.8 ± 24.1 vs. 50.6 ± 14.9, respectively.
Our study showed that TVES + sEMG is a trustworthy method of treatment in premenopausal women with SUI; however, its reliability needs to be established.
Female stress urinary incontinence; Premenopausal age; Transvaginal electrical stimulation; Surface electromyography; Biofeedback
Introduction and hypothesis
Stress urinary incontinence (SUI) is the most common type of urinary incontinence (UI) in pregnant women and is known to have detrimental effects on the quality of life in approximately 54.3 %. Pregnancy is the main risk factor for the development of SUI. This review provides details of the pathophysiology leading to SUI in pregnant women and SUI prevalence and treatment during pregnancy.
We conducted a PubMed search for English-language and human-study articles registered from January 1990 to September 2012. This search was performed for articles dealing with prevalence and treatment of SUI during pregnancy. In the intervention studies, we included studies that used a randomized controlled trial (RCT) design or studies comparing a treatment intervention to no treatment.
A total of 534 articles were identified; 174 full-text articles were reviewed, and 28 of them met eligibility criteria and are reported on here. The mean prevalence of SUI during pregnancy was 41 % (18.6–60 %) and increased with gestational age. The increasing pressure of the growing uterus and fetal weight on pelvic-floor muscles (PFM) throughout pregnancy, together with pregnancy-related hormonal changes, may lead to reduced PFM strength as well as their supportive and sphincteric function. These cause mobility of the bladder neck and urethra, leading to urethral sphincter incompetence. Pelvic floor muscle exercise (PFME) is a safe and effective treatment for SUI during pregnancy, without significant adverse effects.
Understanding these issues can be useful for health-care professionals when informing and counseling pregnant women to help prevent SUI during pregnancy and the postpartum period.
Stress urinary incontinence; Pregnancy; Prevalence; Pathophysiology; Treatment; Review article