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1.  Communication Between Physicians And Spanish-Speaking Latin American Women With Pelvic Floor Disorders: A Cycle Of Misunderstanding? 
Objectives
To assess the effect of the initial visit with a specialist on disease understanding among Spanish-speaking women with pelvic floor disorders.
Methods
Spanish-speaking women with referrals suggestive of urinary incontinence (UI) and/or pelvic organ prolapse (POP) were recruited from public urogynecology clinics. Patients participated in a health literacy assessment and interview before and after their physician encounter. All interviews were analyzed using Grounded Theory qualitative methods.
Results
Twenty-seven women with POP (N=6), UI (N=11), and POP/UI (N=10) were enrolled in this study. The mean age was 55.5 years and the majority of women had marginal levels of health literacy. From our qualitative analysis, three concepts emerged. First, was that patients had poor understanding of their diagnosis before and after the encounter regardless of how extensive the physician’s explanation or level of Spanish-proficiency. Secondly, patients were overwhelmed with the amount of information given to them. Lastly, patients ultimately put their trust in the physician, relying on them for treatment recommendations.
Conclusions
Our findings emphasize the difficulty Spanish-speaking women with low health literacy have in understanding information regarding pelvic floor disorders. In this specific population, the physician has a major role in influencing patients’ treatment decisions and helping them overcome fears they may have about their condition.
doi:10.1097/SPV.0b013e318278cc15
PMCID: PMC3584345  PMID: 23442506
Pelvic Prolapse; Incontinence; Qualitative Methods; Health Literacy; Disease Understanding
2.  Obstetric Sphincter Injury Interacts with Diarrhea and Urgency to Increase the Risk of Fecal Incontinence in Women with IBS 
Objectives
To confirm that fecal urgency and diarrhea are independent risk factors for fecal incontinence (FI), to identify obstetrical risk factors associated with FI in women with IBS (irritable bowel syndrome), and to determine whether obstetric anal sphincter injuries interact with diarrhea or urgency to explain the occurrence of FI.
Methods
The study is a supplement to a diary study of bowel symptoms in 164 female patients with IBS. Subjects completed daily bowel symptom diaries for 90 consecutive days and rated each bowel movement (BM) for stool consistency and presence of urgency, pain, and FI. All female participants from the parent study were invited to complete a telephone-administered 33-item bowel symptom and obstetric history questionnaire which included the Fecal Incontinence Severity Index (FISI).
Results
Out of 164 women in the parent study, 115 (70.1%) completed the interview. Seventy-four (45.1%) reported FI on their diary including 34 (29.6%) who reported at least one episode per month, 112 (97.4%) reported episodes of urgency, and 106 (92.2%) reported episodes of diarrhea. The mean FISI score was 13.9±9.7. Upon multivariable analysis, FI was significantly associated with parity (p=0.007), operative vaginal delivery (p=0.049), obstetrical sphincter lacerations (p=0.007), fecal urgency (p=0.005), diarrhea (p=0.008), and hysterectomy (p=0.004), but was not associated with episiotomy, pelvic organ prolapse, or urinary incontinence. The synergistic interactions of obstetric anal sphincter laceration with urgency (p=0.002) and diarrhea (p=0.004) were significant risk factors for FI.
Conclusion
Fecal urgency and diarrhea are independent risk factors for FI, and they interact with obstetric anal sphincter laceration to amplify the risk of FI.
doi:10.1097/SPV.0b013e31827bfd64
PMCID: PMC3920582  PMID: 23321658
fecal incontinence; obstetric anal sphincter injury; diarrhea; urgency
3.  Condition Specific Quality of Life 24 Months After Retropubic and Transobturator Sling Surgery for Stress Urinary Incontinence 
Aims
To compare quality of life (QoL) and factors associated with QoL change after retropubic (RMUS) and transobturator (TMUS) midurethral slings using the Incontinence Impact Questionnaire, (IIQ) and the International Consultation on Incontinence Questionnaire (ICIQ).
Methods
Five hundred ninety seven women in a multicenter randomized trial of RMUS vs. TMUS were examined. The IIQ and ICIQ were obtained at baseline, 12 and 24 months. Repeated measures analysis of variance tested for differences by treatment group over time. Multivariable analysis identified factors associated with QoL change at 12 months post- operative, controlling for treatment group and baseline QoL.
Results
Improvement in IIQ was associated with: treatment success, younger age, improvement in stress incontinence (SUI) symptom severity and bother (all p < 0.05). Improvement in ICIQ was associated with treatment success, younger age, improvement in SUI symptom severity and bother, lower body mass index and no re-operation (all p < 0.05). Improvement of the IIQ was stable over time (p =0.35) for both treatment groups (p=0.66) whereas the ICIQ showed a small but clinically insignificant decline (p=0.03) in both treatment groups (p=0.51).
Conclusions
Postoperative QOL was improved after RMUS and TMUS. Measures of QOL functioned similarly, although more surgically modifiable urinary incontinence factors predicted improvement with the IIQ.
doi:10.1097/SPV.0b013e318267c004
PMCID: PMC3902543  PMID: 22983273
Urinary incontinence; Quality of life; Midurethral sling
4.  Can women correctly contract their pelvic floor muscles without formal instruction? 
Objectives
It is unknown how many women presenting for primary care can appropriately contract their pelvic floor muscle (PFM) or whether this ability differs between women with or without pelvic floor disorders. We sought to describe the proportion of women who initially incorrectly contract the PFM, and how many can learn after basic instruction.
Methods
This cross-sectional study enrolled 779 women presenting to community based primary care practices. During PFM assessment, research nurses recorded whether women could correctly contract their PFM after a brief verbal cue. We defined POP as prolapse to or beyond the hymen and SUI as a score of > 3 on the Incontinence Severity Index.
Results
PFM contraction was done correctly on first attempt in 85.5%, 83.4%, 68.6%, and 85.8% of women with POP, SUI, both POP and SUI and neither POP nor SUI, respectively (p=0.01 for difference between POP and SUI versus neither POP nor SUI). Of 120 women who initially incorrectly contracted the PFM, 94 (78%) learned after brief instruction. Women with POP were less likely to learn than women with neither POP nor SUI (54.3% vs. 85.7%, p=0.001). Increasing vaginal delivery and decreasing caffeine intake (but not age or other demographic factors) were associated with incorrect PFM contraction; only decreased caffeine intake remained significant on multivariable analysis.
Conclusions
Most women with no or mild pelvic floor disorders can correctly contract their PFM after a simple verbal cue, suggesting that population-based prevention interventions can be initiated without clinical confirmation of correct PFM technique.
doi:10.1097/SPV.0b013e31827ab9d0
PMCID: PMC3551249  PMID: 23321652
Pelvic Organ Prolapse; Stress Urinary Incontinence; Pelvic Floor Muscles; kegel exercise
5.  WEB VS PAPER-BASED COMPLETION OF THE EPIDEMIOLOGY OF PROLAPSE AND INCONTINENCE QUESTIONNAIRE (EPIQ) 
Objectives
To examine the validity and reliability of a web-based version of the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ).
Methods
Participants included 876 women ages 38 to 65 attending primary care clinics in the Salt Lake Valley. Women completed a single web or paper based version of the symptom bother questions from EPIQ, and a subset repeated the same or opposite method at 2 separate time points. To assess subscales for the web-based version factor analysis of the 22 EPIQ items related to pelvic floor disorder (PFD) symptoms was performed using principal components analysis and varimax rotation. Internal consistency was assessed using coefficient alpha. Test-retest and inter-method reliability were assessed using intraclass correlation coefficients (ICC) for domain scores. Correlations above 0.70 were considered acceptable.
Results
Overall, 384 and 492 women completed at least 1 web and 1 paper EPIQ and 93% were Caucasian with mean age of 50±7 years. Of these, 63 completed web-web, 57 web-paper, 47 paper-web and 109 paper-paper test-retest. Overall, factor analyses were consistent with the 7 domains of the original EPIQ. Cronbach’s alpha for the 4 symptomatic PFD domains and range of test-retest reliability for the various administration methods were similar to the original EPIQ instrument. Correlations for domain scores were above 0.70, except the anal incontinence scale (ICC=0.68.)
Conclusions
Web administration of the EPIQ has similar psychometric properties with comparable internal consistency and test-retest reliability when administered in the same modality. Reliability between both methods of administration is acceptable.
doi:10.1097/SPV.0b013e31827bfd93
PMCID: PMC3774148  PMID: 23321654
Epidemiology; internet survey; pelvic floor disorders; questionnaire; web
6.  Communication Barriers among Spanish-speaking Women with Pelvic Floor Disorders: Lost in Translation? 
Female pelvic medicine & reconstructive surgery  2013;19(3):10.1097/SPV.0b013e318288ac1c.
Objectives:
The purpose of our study was to evaluate barriers in communication and disease understanding among office staff and interpreters when communicating with Spanish-speaking women with pelvic floor disorders.
Methods:
We conducted a qualitative study to evaluate barriers to communication with Spanish-speaking women with pelvic floor disorders among office staff and interpreters. Sixteen office staff and interpreters were interviewed; interview questions focused on experiences with Spanish-speaking patients with pelvic floor disorders in the clinic setting. Interview transcripts were analyzed qualitatively using grounded theory methodology.
Results:
Analysis of the interview transcripts revealed several barriers in communication as identified by office staff and interpreters. Three major classes were predominant: patient, interpreter, and system-related. Patient-related barriers included 1) a lack of understanding of anatomy and medical terminology and inhibited discussions due to embarrassment. Provider-related barriers included poor interpreter knowledge of pelvic floor vocabulary and the use of office staff without interpreting credentials. System-related barriers included poor access to information. From these preliminary themes, an emergent concept was revealed: it is highly likely that Spanish-speaking women with pelvic floor disorders have poor understanding of their condition due to multiple obstacles in communication.
Conclusions:
There are many levels of barriers to communications with Latinas treated for pelvic floor disorders, arising from the patient, interpreter, and the system itself. These barriers contribute to a low level of understanding of their diagnosis, treatment options, and administered therapies.
doi:10.1097/SPV.0b013e318288ac1c
PMCID: PMC3826443  PMID: 23611934
pelvic prolapse; urinary incontinence; disease understanding; underserved Latinas
7.  Do symptoms of voiding dysfunction predict urinary retention? 
Objectives
We assessed the relationship between symptoms of voiding dysfunction and elevated post void urinary residual (PVR).
Methods
Cross-sectional study of women presenting for initial evaluation from February through July 2011. Charts were reviewed for demographics, voiding dysfunction symptoms, and examination findings. Urinary retention was defined as PVR ≥100cc. Data are presented as median (interquartile range) or proportion; test characteristics are reported with 95% confidence intervals.
Results
Of 641 eligible women, 57 (8.9%) had urinary retention. Of these, 32 (56.1%) had at least one symptom of voiding dysfunction, most commonly sensation of incomplete emptying (30.1%). Sensitivity and positive predictive values of voiding dysfunction symptoms were low. Of 254 women reporting voiding symptoms, most (87.5%) had PVR<100 and were significantly more likely to have other pelvic floor symptoms and findings.
Conclusions
Patient symptoms do not predict urinary retention. PVR should be measured and other causes of voiding dysfunction symptoms should be considered.
doi:10.1097/SPV.0b013e318274d5c4
PMCID: PMC3512564  PMID: 23143428
Incomplete bladder emptying; Post void residual; Urinary retention; Voiding dysfunction
8.  Patient Understanding of Pelvic Floor Disorders: What Women Want to Know 
Objective
To assess the effect of initial visit with a specialist on disease understanding in women with pelvic floor disorders.
Methods
Women with referrals or chief complaints suggestive of urinary incontinence (UI) or pelvic organ prolapse (POP) were recruited from an academic urology clinic. Patients completed a Test of Functional Health Literacy in Adults (TOFHLA) and scripted interview sessions before and after the physician encounter. Physician treatment plans were standardized based on diagnosis and were explained using models. Interview transcripts were analyzed using qualitative grounded theory methodology.
Results
Twenty women with pelvic floor disorders (UI or POP) were recruited and enrolled in this pilot study. The mean age was 60.5 years (range 31–87 years) and the majority of women were Caucasian with a college degree or beyond. TOFHLA scores indicated adequate to high levels of health literacy. Preliminary themes before and after the physician encounter were extracted from interviews, and two main concepts emerged: 1) After the initial physician visit, knowledge of their diagnosis and the ability to treat their symptoms relieved patient concerns related to misunderstandings of the severity of their disease 2) Patients tended to focus on treatment and had difficulty grasping certain diagnostic terms. This resulted in good understanding of treatment plans despite an inconsistent understanding of diagnosis.
Conclusion
Our findings demonstrated a significant effect of the initial physician visit on patient understanding of her pelvic floor disorder. Despite the variation in diagnostic recall after the physician encounter, patients had good understanding of treatment plans. This served to increase perceived control and adequately relieve patient fears.
doi:10.1097/SPV.0b013e318254f09c
PMCID: PMC3733672  PMID: 22543763
9.  Health Literacy and Disease Understanding among Aging Women with Pelvic Floor Disorders 
OBJECTIVES
Few studies on health literacy and disease understanding among women with pelvic floor disorders have been published. We conducted a pilot study to explore the relationship between disease understanding and health literacy, age, and diagnosis type among women with urinary incontinence and pelvic organ prolapse.
METHODS
Study subjects were recruited from urology and urogynecology specialty clinics based on a chief complaint suggestive of urinary incontinence or pelvic prolapse. Subjects completed questionnaires to assess symptom severity and health literacy was measured using the Test of Functional Health Literacy in Adults. Patient-physician interactions were audiotaped during the office visit. Immediately afterwards, patients were asked to describe diagnoses and treatments discussed by the physician and record them on a checklist, with follow-up phone call where the same checklist was administered 2–3 days later.
RESULTS
A total of 36 women with pelvic floor disorders, aged 42–94, were enrolled. We found that health literacy scores decreased with increasing age; however, all patients had low percentage recall of their pelvic floor diagnoses and poor understanding of their pelvic floor condition despite high health literacy scores. Patients with pelvic prolapse appeared to have worse recall and disease understanding than patients with urinary incontinence.
CONCLUSIONS
High health literacy as assessed by the TOFHLA may not correlate with patients' ability to comprehend complex functional conditions such as pelvic floor disorders. Lack of understanding may lead to unrealistic treatment expectations, inability to give informed consent for treatment, and dissatisfaction with care. Better methods to improve disease understanding are needed.
doi:10.1097/SPV.0b013e31826fb8d3
PMCID: PMC3723393  PMID: 23143427
pelvic floor disorders; health literacy; incontinence; pelvic organ prolapse
10.  TVT-Secur (Hammock) Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures 
Objectives
This study aimed to compare TVT-Secur (TVT-S) and TVT-Obturator (TVT-O) suburethral slings for treatment of stress urinary incontinence (SUI).
Methods
This was a single-center, nonblinded, randomized trial of women with SUI who were randomized to TVT-S or TVT-O from May 2007 to April 2009. The primary outcome, SUI on cough stress test (CST), and quality-of-life and symptom questionnaires (Pelvic Floor Distress Inventory [PFDI-20] and Pelvic Floor Impact Questionnaire [PFIQ-7]) were assessed at 12 weeks and 1 year.
Results
Forty-three women were randomized to TVT-S and 44 to TVT-O. There were no differences in median baseline PFDI-20 and PFIQ-7. Twenty-two (52.4%) of 42 participants randomized to TVT-S had a positive CST result at evaluation after 12 weeks or 1 year, whereas 4 (9.1%) of the 44 in the TVT-O group had a positive CST result. The intent-to-treat analysis showed that the risk of a positive CST result was 6 times higher after TVT-S than TVT-O (risk ratio, 6.0; 95% confidence interval [CI], 2.3–16.0). Among women not lost to follow-up, the risk ratio for a positive CST result after TVT-S compared with TVT-O was 17.9 (95% CI, 2.5–128.0) at 12 weeks and 3.5 (95% CI, 1.1–11.0) at 1 year. Both TVT-S and TVT-O resulted in improved quality of life and symptoms at 12 weeks. There was no difference between the groups for PFDI-20 (P = 0.40) or PFIQ-7 (P = 0.43). A similar pattern was seen at 1 year (P = 0.85 and P = 0.36).
Conclusions
The TVT-S seems to have a higher risk of positive postoperative CST result; however, the procedures result in similar improvements in quality of life and symptoms.
doi:10.1097/SPV.0b013e31823bdbcf
PMCID: PMC3712515  PMID: 22453267
TVT-Secur; TVT-Obturator; stress incontinence; efficacy
11.  Assessment of Women With Defecatory Dysfunction and Manual Splinting Using Dynamic Pelvic Floor Magnetic Resonance Imaging 
Objective
This study aimed to describe magnetic resonance imaging (MRI) findings in women with defecatory dysfunction who perform manual splinting.
Methods
This is a retrospective study of 29 patients from a single urogynecology center who presented with complaints of defecatory dysfunction and who reported manual splinting to assist with bowel movements. Patients were scheduled for an MRI study with a novel “splinting” protocol to evaluate the effects of their manual splinting on the pelvic floor. The protocol involved asking patients to splint during the MRI, as they normally would when trying to defecate. The goal was to evaluate any change in pelvic anatomy and compensation for an anatomic defect that could potentially lead to their defecatory dysfunction. Magnetic resonance images of the pelvis were obtained at rest, with pelvic floor contraction, with Valsalva, and during manual splinting. These images were then reviewed by radiologists who evaluated various parameters, including anorectal angle, levator ani muscle integrity, and the presence of rectocele, cystocele, apical prolapse, and enterocele. The external and internal anal sphincters were also evaluated for continuity.
Results
From September 2008 to October 2010, 29 women reported defecatory dysfunction and the need for manual splinting. Their mean (SD) age was 55.2 (10.5) years. Magnetic resonance images showed a rectocele in 86.2% of the study group, cystocele in 75.9%, enterocele in 10.3%, and a defect of the levator ani muscles in 17.2%. Twentyone (72.4%) women had more than 1 of these defects. In addition, 27.6% had an anorectal angle less than 90 degrees or greater than 105 degrees.
Patients in the study group splinted in the vagina (58.6%), on the perineum (31.0%), or on the buttock (10.3%). In all but 1 woman (96.6%), splinting improved or completely corrected the identified defect(s) as evidenced with MRI. Among those who used vaginal splinting, 52.9% of defects were corrected and 47.1% were improved. Perineal splinting corrected 55.6% and improved 33.3% of cases and was ineffective in 11.1% of cases, whereas buttock splinting corrected 33.3% and improved 66.7% of cases.
Conclusions
Most women in our study group who used manual splinting to assist in defecation are compensating for a pelvic floor defect that can be detected on MRI. Magnetic resonance imaging of the pelvis may help elucidate the etiology of the defecatory dysfunction in some women and may assist pelvic reconstructive surgeons in planning surgical correction of pelvic floor defects. Magnetic resonance imaging may also identify defects in the pelvic floor that are, at the present time, not amenable to surgical correction.
doi:10.1097/SPV.0b013e31823bdb98
PMCID: PMC3707403  PMID: 22453259
splinting; defecatory dysfunction; MRI; pelvic organ prolapse; pelvic floor; constipation; dynamic MRI; obstructed defecation; rectocele; cystocele; enterocele; apical vaginal prolapse; vaginal vault prolapse
12.  Longitudinal Changes in Pelvic Organ Support Among Parous Women 
Objective
The objective of this study was to characterize changes in pelvic organ support and symptoms of prolapse over time and identify characteristics associated with worsening of support.
Methods
Participants were recruited based on the mode of delivery (cesarean vs vaginal delivery) of their first child. The Pelvic Organ Prolapse Quantification system was used to describe support at baseline and 12 to 18 months later. Symptoms were assessed using a validated questionnaire. Outcomes of interest included the proportion of women with a change in support greater than 1 cm at the anterior vaginal wall (Ba) or posterior vaginal wall (Bp) and a change in support greater than 2 cm at the apex (C). Characteristics associated with worsening of support were identified using 2-sided Fisher’s exact test and multivariable logistic regression.
Results
Among 749 participants, 60% had delivered by cesarean delivery only. Worsening support at Ba, Bp, and C was observed in 8%, 2%, and 6%, respectively. Worsening at any point was observed in 110 women (15%). Women with prolapse symptoms at baseline were not more likely to experience worsening of support. In a multivariable model, age older than 40 years (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.09–2.49), vaginal delivery (OR, 3.12; 95% CI, 1.38–7.07), and genital hiatus greater than or equal to 2 (OR, 2.36; 95% CI, 1.03–5.43) were all associated with worsening support in at least 1 compartment.
Conclusions
Over 12 to 18 months, characteristics most strongly associated with worsening of pelvic support include genital hiatus size, vaginal birth, and age.
doi:10.1097/SPV.0b013e3182626294
PMCID: PMC3657298  PMID: 22777372
pelvic organ prolapse; child birth; vaginal delivery; natural history; longitudinal study
13.  Validation of the Activities Assessment Scale in Women undergoing Pelvic Reconstructive Surgery 
Objective
The Activities Assessment Scale (AAS) is a 13-item postoperative functional activity scale validated in men undergoing hernia surgery. We evaluated the psychometric characteristics of the AAS in women undergoing vaginal surgery for prolapse (POP) and stress incontinence (SUI).
Methods
Participants included 163 women with POP and SUI enrolled in a randomized trial comparing sacrospinous ligament fixation to uterosacral vault suspension with and without perioperative pelvic floor muscle training. Participants completed the AAS and SF-36 at baseline and 2-weeks and 6-months post-operatively. Internal reliability of the AAS was evaluated using Cronbach’s alpha. Construct validity and responsiveness were examined in cross-sectional and longitudinal data using Pearson’s correlation coefficient and ANOVA. The AAS is scored from 0–100 (higher scores = better function).
Results
Mean baseline AAS score was 87± 17.3 (range 25 to 100). Functional activity declined from baseline to 2-weeks post-operatively (mean change −4.5; 95% CI −7.6 to −1.42) but improved above baseline at 6-months (mean change +10.9; 95% CI 7.8 to 14.0). Internal reliability of the AAS was excellent (Cronbach’s Alpha = 0.93). Construct validity was demonstrated by a correlation of 0.59–0.60 between the AAS and SF-36 Physical Functioning Scale (p<0.0001) and lower correlations between the AAS and other SF-36 scales. Patients who improved in physical functioning based on the SF-36 between 2-weeks and 6-months postoperatively showed an effect size of 0.86 for change in the AAS over the same time period.
Conclusions
The AAS is a valid, reliable and responsive measure for evaluation of physical function in women after pelvic reconstructive surgery.
doi:10.1097/SPV.0b013e31825e6422
PMCID: PMC3666046  PMID: 22777368
Functional Activity; Postoperative Activity; Scales; Pelvic Reconstructive Surgery; Pelvic Organ Prolapse
14.  Validation of the Surgical Pain Scales in Women undergoing Pelvic Reconstructive Surgery 
Objective
Surgical Pain Scales (SPS) consist of 4 items that measure pain at rest, during normal activities, during work/exercise and quantify unpleasantness of worst pain, which are valid and responsive in men undergoing hernia repair. Our objective was to evaluate the psychometric properties of SPS in women undergoing vaginal surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Methods
We modified SPS by converting original response scales from a visual analog scale (VAS) to Numerical Rating Scales (NRS). NRS have lower error rates and higher validity than VAS. The sample included 169 women with stage II–IV POP and SUI in a randomized trial comparing sacrospinous ligament fixation to uterosacral vault suspension with and without pelvic floor muscle training. Participants completed SPS and SF-36 at baseline, 2-weeks and 6-months after surgery. Construct validity and responsiveness were examined in cross-sectional and longitudinal data using Pearson’s correlation and ANOVA.
Results
Pain at rest, during normal activities and during work/exercise worsened at 2-weeks (p<0.05) and all measures of pain improved from baseline to 6 months (p<0.0001). Construct validity was demonstrated by correlations of .51–.74 between SPS and the SF-36 Bodily Pain Scale (p<0.0001). Pain worsened on SF-36 between baseline and 2-weeks in 63% of participants and this group demonstrated a mean increase in pain of 1.9 (SD 2.8) on the SPS (effect size 0.99) confirming responsiveness of the scale.
Conclusions
The modified Surgical Pain Scales are valid and responsive in women after pelvic reconstructive surgery.
doi:10.1097/SPV.0b013e31825d65aa
PMCID: PMC3677159  PMID: 22777367
Postoperative Pain; Scales; Pelvic Reconstructive Surgery; Pelvic Organ Prolapse
15.  Informed Consent for Sacrocolpopexy: Is Counseling Effective in Achieving Patient Comprehension? 
Objectives
The purpose of the informed consent process is to reinforce a patient’s understanding of her condition and treatment alternatives and to thoroughly review the chosen procedure with its risks and benefits. We aimed to evaluate how well women who consented to undergo sacrocolpopexy understood their planned procedure.
Study Design
We prospectively studied women who had undergone detailed informed consent in preparation for laparoscopic or robotic sacrocolpopexy. A 15-item questionnaire was developed and administered before surgery to assess the patients’ comprehension of preoperative counseling.
Results
Fifty women were enrolled. The mean knowledge score was 69.7%. Sixty-four percent of the patients did not recall that they could have a prolapse repair without mesh, 44% did not understand the location of mesh attachment, and 34% believed there was no risk of recurrent prolapse. Women who completed the questionnaire within 3 weeks of signing the surgical consent had a higher mean score (78.5%) than women for whom 3 or more weeks elapsed (66.3%; P=0.02).
Conclusion
Despite detailed preoperative discussion, women had deficiencies in their understanding of sacrocolpopexy. New methods to improve patient education and comprehension should be considered.
doi:10.1097/SPV.0b013e31827816c5
PMCID: PMC3695398  PMID: 23143430
Comprehension; informed consent; prolapse; sacrocolpopexy
16.  Estrogen Affects the Glycosaminoglycan Layer of the Murine Bladder 
Objectives
Urinary tract infections (UTIs), commonly caused by uropathogenic Escherichia coli (UPEC), confer significant morbidity among postmenopausal women. Glycosaminoglycans (GAGs) comprise the first line of defense at the bladder’s luminal surface. Our objective was to use a murine model of menopause to determine whether estrogen status affects the GAG layer in response to UPEC infection.
Methods
Adult female mice underwent sham surgery (SHAM, n = 18) or oophorectomy (OVX, n = 66) to establish a murine model of menopause. A subset of oophorectomized mice underwent hormone therapy (HT, n = 33) with 17β-estradiol. Mice were inoculated with UPEC and killed at various time points; bladders were collected and GAG layer thickness was assessed in multiple bladder sections. Sixteen measurements were made per bladder. A repeated-measures 2-way analysis of variance was performed to determine the effect of time after infection and hormonal condition on GAG thickness. We also investigated the molecular underpinnings of GAG biosynthesis in response to alterations in estrogen status and infection.
Results
We did not observe significant difference of GAG thickness among the 3 hormonal conditions; however, the time course of GAG thickness was significantly different (P <0.05). The OVX mice demonstrated significantly greater thickness at 72 hours after infection (P = 0.0001), and this effect was shifted earlier (24 hours after infection) on the addition of HT (P = 0.001). At 2 to 4 weeks after infection, GAG thickness among all cohorts was not significantly different from baseline. In addition, quantitative reverse transcription–polymerase chain reaction analysis revealed that GAG biosynthesis is altered by estrogen status at basal level and on infection.
Conclusions
The GAG layer is dynamically altered during the course of UTI. Our data show that HT positively regulates GAG layer thickness over time, as well as the composition of the GAGs. In addition, the GAG sulfation status can be influenced by estrogen levels in response to UPEC infection. The protective effects of the GAG layer in UTI may represent pharmacologic targets for the treatment and prevention of post-menopausal UTI.
doi:10.1097/SPV.0b013e31824b76bd
PMCID: PMC3686500  PMID: 22543765
murine bladder; urinary tract infection; glycosaminoglycan; estrogen; hormone therapy
17.  PATTERNS OF PESSARY CARE AND OUTCOMES FOR MEDICARE BENEFICIARIES WITH PELVIC ORGAN PROLAPSE 
Objectives
Using a national dataset, we sought to assess patterns of pessary care in older women with pelvic organ prolapse (POP) and subsequent outcomes, including rates of complications and surgical treatment of POP.
Methods
Public Use Files from the United States Centers for Medicare and Medicaid Services were obtained for a 5% random national sample of beneficiaries from 1999 to 2000. Diagnostic and procedural codes (ICD-9-CM and CPT-4) were used to identify women with pelvic organ prolapse (POP) and those treated with pessary. Individual subjects were followed longitudinally for nine years. Across this duration, patient care and outcomes (e.g., return clinic visits, repeat pessary placements, complications, and rate of surgical treatment of prolapse) were assessed.
Results
Of 34,782 women diagnosed with POP, 4,019 (11.6%) were treated with a pessary. In the initial three months after pessary placement, 40% underwent a follow-up visit with the provider who had placed the pessary, and through nine years after the initial fitting, 69% had such a visit. During this period, 3% of subjects developed vesicovaginal or rectovaginal fistulas, and 5% had a mechanical genitourinary device complication. Twelve percent of women underwent surgery for POP by one year; with 24% by nine years.
Conclusions
Pessary can be effectively used for management of POP in older women. Despite this, a low percentage of Medicare beneficiaries undergo pessary fitting. Lack of continuity of care results in a small, but unacceptable rate of vaginal fistulas.
doi:10.1097/SPV.0b013e31827e857c
PMCID: PMC3635496  PMID: 23611931
pelvic organ prolapse; Medicare; pessary; Public Use Files
18.  Major postoperative complications after benign gynecologic surgery: a clinical prediction model 
Objective
To create a clinical prediction tool to differentiate women at risk for postoperative complications after benign gynecologic surgery.
Methods
We utilized the 2005 to 2009 American College of Surgeons National Surgical Quality Improvement Program participant use data files to perform a secondary dataset analysis of women over the age of 16 years who underwent benign gynecologic procedures. We then temporally divided women into two similar cohorts. Our derivation cohort included all women undergoing benign gynecologic procedures in the 2005 to 2008. Our validation cohort included all women undergoing benign gynecologic procedures in the 2009. The primary outcome, composite 30-day major postoperative complications, was analyzed as a dichotomous variable. A prediction tool was then constructed to predict the occurrence of postoperative complications built from the logistic regression model by rounding the value of each estimated β coefficient to the nearest integer. An individual’s risk score was then computed by summing the number of points based on her preoperative characteristics. This risk score was then used to categorize women into low, medium, and high-risk groups.
Results
A prediction tool for benign gynecologic procedures identified women at low (2.7% and 2.4%), medium (6.3% and 6.8%), and high (29.5% and 23.8%) risk of complications in the derivation and validation cohorts, respectively.
Conclusion
A prediction tool can differentiate women at risk for postoperative complications after benign gynecologic surgery.
doi:10.1097/SPV.0b013e318263a210
PMCID: PMC3631542  PMID: 22983270
ACS NSQIP; gynecology; medical comorbidities; prediction tool; surgical outcomes
19.  Characterizing the Phenotype of Advanced Pelvic Organ Prolapse 
Objective
Genetic studies require a clearly defined phenotype to reach valid conclusions. Our aim was to characterize the phenotype of advanced prolapse by comparing women with stage III to IV prolapse with controls without prolapse.
Methods
Based on the pelvic organ prolapse quantification examination, women with stage 0 to stage I prolapse (controls) and those with stage III to stage IV prolapse (cases) were prospectively recruited as part of a genetic epidemiologic study. Data regarding sociodemographics; medical, obstetric, and surgical history; family history; and body mass index were obtained by a questionnaire administered by a trained coordinator and abstracted from electronic medical records.
Results
There were 275 case patients with advanced prolapse and 206 controls with stage 0 to stage I prolapse. Based on our recruitment strategy, the women were younger than the controls (64.7±10.1 vs 68.6±10.4 years; P<0.001); cases were also more likely to have had one or more vaginal deliveries (96.0% vs 82.0%; P<0.001). There were no differences in race, body mass index, and constipation. Regarding family history, cases were more likely to report that either their mother and/or sister(s) had prolapse (44.8% vs 16.9%, P<0.001). In a logistic regression model, vaginal parity (odds ratio, 4.05; 95% confidence interval, 1.67–9.85) and family history of prolapse (odds ratio, 3.74; 95% confidence interval, 2.16–6.46) remained significantly associated with advanced prolapse.
Conclusions
Vaginal parity and a family history of prolapse are more common in women with advanced prolapse compared to those without prolapse. These characteristics are important in phenotyping advanced prolapse, suggesting that these data should be collected in future genetic epidemiologic studies.
doi:10.1097/SPV.0b013e31826a53de
PMCID: PMC3505456  PMID: 22983275
pelvic organ prolapse; phenotype; genetic epidemiology; family history
20.  Neuromuscular Characterization of the Urethra in Continent Women 
Objectives
To describe quantitative urethral function parameters in a racially diverse group of continent women.
Materials and Methods
Following Institutional Review Board approval, we recruited women without urinary incontinence from the community. To be considered continent, participants answered “never” to the first six questions on the stress subscale of the Medical, Epidemiologic, and Social Aspects of Aging urinary incontinence (MESA) questionnaire. Participants all underwent quantitative concentric urethral electromyography (EMG) and urodynamic testing (UDS).
Results
Thirty-one women with a mean±SD age of 39±14 years underwent EMG and UDS. The cohort was racially diverse with 13 Caucasians (43%), 13 African Americans (43%), and 4 Hispanics (14%). Body mass index (BMI) (P=.12, .06), age (P=.40, .64), and vaginal parity (P=.53, .76) did not differ by race or ethnicity. We did not detect differences in any EMG parameter by race, ethnicity or vaginally parity. A mean (range) of 30 motor unit action potential analysis (MUP) (10-55) were identified and analyzed in Multi-MUP analysis and 14 (8-21) were identified and analyzed in IP analysis. On average, 37±20% MUPs were polyphasic.
Age significantly correlated with several measures of urethral sphincter function. Increasing age was inversely correlated with interference analysis (IP) turns (−.57, p=.001), IP amplitude (r=−.43, p=.02), IP turns/amplitude (r=−.54, p=.003), maximum urethral closure pressures (MUCP) (r=−.41, p=.04). Similarly, MUCP correlated with IP amplitude (r=.38, p=.04).
Conclusions
This urethral neuromuscular function data on the largest cohort of continent women fully characterized with quantitative urethral EMG demonstrates significant neuropathic MUP changes with advancing age.
doi:10.1097/SPV.0b013e31822dd012
PMCID: PMC3319049  PMID: 22453105
Electromyography; EMG; Urethra; Urethral sphincter; Stress Incontinence
21.  PATIENT EXPECTATIONS DID NOT PREDICT OUTCOME OF DRUG AND BEHAVIORAL TREATMENT OF URGENCY URINARY INCONTINENCE 
Objectives
To determine whether expectations of treatment outcomes in women participating in a drug and behavioral treatment trial for urge urinary incontinence are related to patient factors, demographics, health-related locus of control and treatment outcomes.
Methods
Baseline assessments included expectations (improvement in bladder condition, time to improvement in bladder condition, and duration of improvement) and the multidimensional health locus of control (MHLC) scale. Outcomes were measured by patient global impression of improvement (PGI-I) at the end of active treatment (10 weeks) and 8 months after trial start.
Results
At baseline among 173 subjects, 114 (66%) believed their incontinence would get ‘very much better,’ 94 (55%) expected improvement by one month, and 111 (66%) expected improvement would last the rest of their lives.. There were no significant associations between baseline expectations or MHLC with PGI-I at 10 weeks or 8 months.
Conclusions
Expectations of treatment outcome and MHLC did not predict eventual patient-reported treatment outcome in this sample of women with urge-predominant urinary incontinence participating in a trial of drug and behavioral therapy.
doi:10.1097/SPV.0b013e31822dd10b
PMCID: PMC3329782  PMID: 22453106
Urinary incontinence; urinary urgency incontinence; patient expectations
22.  Pelvic Floor Symptoms Improve Similarly After Pessary and Behavioral Treatment for Stress Incontinence 
Objective
To determine if differences exist in pelvic symptom distress and impact in women randomized to pessary versus behavioral therapy for treatment of stress urinary incontinence (SUI).
Methods
Change in symptom and condition-specific health related quality of life (HRQOL) measures were compared between pessary and behavioral groups 3-months after randomization in the Ambulatory Treatments for Leakage Associated with Stress Incontinence [ATLAS]) trial. 446 women with symptoms of SUI were randomized to continence pessary, behavioral therapy (pelvic floor muscle training and continence strategies) or combination therapy. Validated measures utilized included urinary (UDI), prolapse (POPDI) and colorectal (CRADI) scales of the Pelvic Floor Distress Inventory; urinary (UIQ), prolapse (POPIQ) and colorectal (CRAIQ) scales of the Pelvic Floor Impact Questionnaire; and stress and urge scale of the Questionnaire for Urinary Incontinence Diagnosis (QUID). Student t- test and ANOVA was used to compare scores within and between groups.
Results
Mean age of participants was 49.8±11.9 years; 84% were Caucasian and 10% African American. 149 were randomized to pessary and 146 to behavioral therapy. Baseline symptoms and HRQOL scores were significantly reduced within treatment arms at three months post randomization, but there was no statistically significant difference between groups.
Conclusion
There was no difference in pelvic floor symptom bother and HRQOL between the pessary and behavioral therapy arms in women undergoing conservative treatment for SUI. Individualized preference issues should be considered in the approach to the non-surgical treatment of SUI.
doi:10.1097/SPV.0b013e31824a021d
PMCID: PMC3423640  PMID: 22453323
Pessary; Behavioral Therapy; Stress Urinary Incontinence
23.  Do Women Understand Urogynecologic Terminology? 
Objectives
The aims of this study were to describe women’s stated knowledge of the primary urogynecologic diagnostic terms (urinary incontinence, pelvic floor disorder, and pelvic organ prolapse) and to assess factors associated with knowledge.
Methods
Before any education about pelvic floor disorders, 376 women presenting to primary care–level gynecologic clinics were asked whether they knew what the terms urinary incontinence, pelvic organ prolapse, and pelvic floor disorder meant. χ2 and t tests were used to compare characteristics of women with complete knowledge versus partial or no knowledge of terms. P < 0.05 was considered significant.
Results
Of all women, 25% knew all 3 terms and 18% knew none. Moreover, 80%, 52%, and 27% of women reported that they knew the meaning of the terms urinary incontinence, pelvic organ prolapse, and pelvic floor disorder, respectively. Of women with stress urinary incontinence symptoms, 88% knew the term urinary incontinence compared with 78% without stress urinary incontinence (P = 0.07). Of 41 women, 31 (76%) with the symptom of vaginal bulge knew the term pelvic organ prolapse compared with 49% without (P = 0.001). Only higher education and symptom of vaginal bulge were associated with complete knowledge of the 3 terms; 30% of women who completed college or higher reported complete knowledge compared with 18% who did not (P = 0.013).
Conclusions
Public health campaigns using terms pelvic organ prolapse or pelvic floor disorders are unlikely to reach most women. Further education and research are needed to improve women’s health literacy in urogynecology.
doi:10.1097/SPV.0b013e31822dcffe
PMCID: PMC3185309  PMID: 21984964
pelvic floor disorder; health literacy; pelvic organ prolapse; urinary incontinence
24.  Long-Term Outcomes of the Total or Supracervical Hysterectomy (TOSH) Trial 
BACKGROUND
Participants in the multi-center, randomized Total or Supracervical Hysterectomy (TOSH) trial showed within-group improvement in pelvic floor symptoms 2 years post-surgery and no differences between supracervical (SCH) versus total hysterectomy (TAH). This study describes longer term outcomes from the largest recruiting site.
STUDY DESIGN
Questionnaires addressing pelvic symptoms, sexual function, and health-related quality of life were administered. Linear models and McNemar’s test were utilized.
RESULTS
Thirty-seven participants (69%) responded (19 TAH, 18 SCH); mean follow up was 9.1±0.7 years. No between-group differences emerged in urinary incontinence, voiding dysfunction, pelvic prolapse symptoms and overall health related quality of life (HRQOL). Within-group analysis showed significant improvement in the ability to have and enjoy sex (P = 0.002) and in the SF-36 physical component summary score (P = 0.03) among women randomized to TAH.
CONCLUSION
9 years after surgery, TOSH participants continue to experience improvement and show no major between-group differences in lower urinary tract or pelvic floor symptoms conferring no major benefit of SCH over TAH.
doi:10.1097/SPV.0b013e3181cec343
PMCID: PMC3252027  PMID: 22229107
25.  Urgency Urinary Incontinence in Women ≥ 50 years: Incidence, Remission and Predictors of Change 
Objectives
To estimate 2 year incidence, remission and predictors of urgency urinary incontinence (UUI) in a community based population of women ≥50.
Methods
We analyzed 2004–2006 data in the Health and Retirement Study. Subjects were women ≥ 50 with baseline and follow-up UUI information. UUI incidence and remission were calculated. Predictors of UUI progression and improvement were estimated controlling for age, ethnicity, body mass index (BMI), parity, psychiatric illness, medical co-morbidities, functional limitations and stress urinary incontinence (SUI). We evaluated whether baseline UUI status predicted follow-up status and used multivariable logistic regression to identify predictor variables.
Results
8,581 women reported UUI status at baseline and follow-up. Of 7,244 women continent at baseline, 268 affirmed UUI at follow-up for a 2 year incidence of 3.7%. Of 581 women with UUI at baseline, 150 were continent at follow-up for a 2 year remission of 25.8%. Predictors of UUI development included increased age (7th and 10th decade compared to 6th decade; OR 1.5 and 7.2, CI 1.1–2.1 and 4.2–12.5, respectively), obesity (OR 1.6, CI 1.2–2.1), history of psychiatric illness (OR 1.6, CI 1.3–2.0), functional limitations (OR 6.2, CI 4.2–9.2) and SUI (OR 5.0, CI 3.0–8.3). Women who denied UUI at baseline were also likely to deny UUI at follow-up (OR 47.4, CI 22.9–98.1).
Conclusions
In this community based population of women ≥ 50 UUI incidence was low and remission was high. Predictors of UUI included increased age, severe obesity, functional limitations, a positive psychiatric history and incontinence status at baseline.
doi:10.1097/SPV.0b013e31820446e6
PMCID: PMC3042699  PMID: 21359159
incidence; urgency; urinary; incontinence

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