A randomized trial of vaginal mesh attachment techniques for minimally invasive sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: We investigated the efficiency and efficacy of vaginal mesh attachment using interrupted, non-barbed, delayed absorbable sutures in comparison with a running, barbed, delayed absorbable suture during laparoscopic sacrocolpopexy (LSC) and robotic sacrocolpopexy (RSC). METHODS: Women undergoing LSC or RSC were recruited. Participants were randomized to at least six 0 PDS non-barbed interrupted sutures or at least six passes of a 1 PDS barbed suture (Quill™) on each anterior and posterior polypropylene mesh leaflet. The primary outcome was the time to attach the mesh to the vagina. The LSC and RSC groups were block randomized by suture type. Secondary outcomes included: (1) intraoperative surgeon assessment of satisfaction as measured using a 10-cm visual analog scale (VAS), (2) postoperative POP-Q evaluation for anatomic failure, and (3) overall appearance of vaginal walls measured using a VAS. RESULTS: Of the 64 included subjects who were randomized, 32 had mesh attachment with the barbed suture (16 LSC, 16 RSC) and 32 had attachment with non-barbed sutures (16 LSC, 16 RSC). Among all the subjects (LSC and RSC), the non-barbed suture group had significantly longer mesh attachment times than the barbed suture group (42 vs. 29 min, p < 0.001). The non-barbed suture group had significantly better scores for intraoperative ease of suture placement, surgeon satisfaction with mesh appearance, and global satisfaction. At 12 months, there were no significant differences in anatomic failure between the suture groups or overall appearance of the vaginal walls (p > 0.05). CONCLUSIONS: The barbed suture technique was 11 - 16 min faster for attaching mesh to the vagina than the non-barbed suture technique. Anatomic outcomes at 12 months were comparable between the suture groups. It is reasonable to use a running, barbed suture in minimally invasive sacrocolpopexy.

An update on the current and future demand for care of pelvic floor disorders in the United States.

OBJECTIVE: In 2001, we predicted a 45% increase in the demand for care of women with pelvic floor disorders (PFDs) between 2000 and 2030. However, in 2010, we observed that in our clinic demand for care had increased substantially more than expected. Using updated data, we sought to provide more accurate projections of future demand for care of pelvic floor disorders in the United States. STUDY DESIGN: Demographic data on all new female patients between 30 and 89 years of age seen for pelvic floor disorders in our Urogynecology Clinic between 2009 and 2011 were analyzed. These data were combined with United States Census Bureau projections for 2010 and 2030 stratified by 10-year age blocks. RESULTS: In 2010, our clinic saw a 116% increase in new patients per year compared with 2000. There was an 85% increase in new patient visits per 1000 women per year compared with 2000. We estimate that 1,218,371 new patient visits took place in the United States in 2010 and predict 1,644,804 visits will occur in 2030. CONCLUSION: If the United States population increases 24% by 2030 as projected by the United States Census Bureau, we predict the demand for care for pelvic floor disorders will increase by 35% between 2010 and 2030. This new, more accurate projection for 2030 is based on improved baseline data from 2010 and is 72% higher than we predicted in 2000. Accurately quantifying this growing demand for care of pelvic floor disorders is important for public health planning and physician training.

Prevalence and risk factors for mesh erosion after laparoscopic-assisted sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to identify risk factors for mesh erosion in women undergoing minimally invasive sacrocolpopexy (MISC). We hypothesize that erosion is higher in subjects undergoing concomitant hysterectomy. METHODS: This is a retrospective cohort study of women who underwent MISC between November 2004 and January 2009. Demographics, operative techniques, and outcomes were abstracted from medical records. Multivariable regression identified odds of erosion. RESULTS: Of 188 MISC procedures 19(10%) had erosions. Erosion was higher in those with total vaginal hysterectomy (TVH) compared to both post-hysterectomy (23% vs. 5%, p = 0.003) and supracervical hysterectomy (SCH) (23% vs. 5%, p = 0.109) groups. In multivariable regression, the odds of erosion for TVH was 5.67 (95% CI: 1.88-17.10) compared to post-hysterectomy. Smoking, the use of collagen-coated mesh, transvaginal dissection, and mesh attachment transvaginally were no longer significant in the multivariable regression model. CONCLUSION: Based on this study, surgeons should consider supracervical hysterectomy over total vaginal hysterectomy as the procedure of choice in association with MISC unless removal of the cervix is otherwise indicated.

Update of AUA guideline on the surgical management of female stress urinary incontinence.

PURPOSE: We updated the 1997 American Urological Association guideline on female stress incontinence. MATERIALS AND METHODS: MEDLINE searches of English language publications from 1994 and new searches of the literature published between December 2002 and June 2005 were performed using identified MeSH terms. Articles were selected for the index patient defined as the otherwise healthy woman who elected to undergo surgery to correct stress urinary incontinence or the otherwise healthy woman with incontinence and prolapse who elected to undergo treatment for both conditions. RESULTS: A total of 436 articles were identified as suitable for inclusion in the meta-analysis, and an additional 155 articles were suitable for complications data only due to insufficient followup of efficacy outcomes in the latter reports. Surgical efficacy was defined using outcomes pre-specified in the primary evidence articles. Urgency (resolution and de novo) was included as an efficacy outcome due to its significant impact on quality of life. The primary efficacy outcome was resolution of stress incontinence measured as completely dry (cured/dry) or improved (cured/improved). Complications were analyzed similarly to the efficacy outcomes. Subjective complications (pain, sexual dysfunction and voiding dysfunction) were also included as a separate category. CONCLUSIONS: The surgical management of stress urinary incontinence with or without combined prolapse treatment continues to evolve. New technologies have emerged which have impacted surgical treatment algorithms. Cystoscopy has been added as a standard component of the procedure during surgical implantation of slings.

Urinary frequency in community-dwelling women: what is normal?

OBJECTIVE: The objective of the study was to assess urinary frequency in community-dwelling women. STUDY DESIGN: Voiding habits were assessed in 4061 women 25-84 years of age using survey responses from the Epidemiology of Prolapse and Incontinence Questionnaire. Bother related to daytime and nighttime frequency was assessed with 100-mm visual analog scales and compared using t tests and analysis of variance. RESULTS: Median daytime frequency was every 3-4 hours. Urinary frequency every 2 hours or more occurred in 27% and was more bothersome than every 3-4 hours or less (51.7 +/- 30.1 mm vs 23.6 +/- 23.7 mm; P < .001). Nocturia was reported in 72%, whereas 33% had 2 or more voids per night. Bother increased with increasing nighttime frequency (27.3 +/- 26.3 for 1 time vs 57.3 +/- 28.5 for > or = 2 times; P < .001). CONCLUSION: Bothersome urinary frequency is common and occurs when frequency is at least every 2 hours by day and more than once per night.

Prevalence and co-occurrence of pelvic floor disorders in community-dwelling women.

OBJECTIVE: To assess the effect of age on prevalence of pelvic floor disorders and report the co-occurrence of these conditions in community-dwelling women. METHODS: Stress urinary incontinence (SUI), overactive bladder (OAB), pelvic organ prolapse (POP), and anal incontinence were assessed using a validated questionnaire among 25- to 84-year-old women. Women screened positive for each disorder based on reported symptoms and their degree of bother. Covariates were assessed through self-report. Prevalence of each disorder was compared across four 15-year age groups using chi(2) tests. Multiple logistic regression was used to adjust for confounders. RESULTS: Among 4,103 women (mean age 56.5+/-15.8 years), the prevalence of SUI was 15%, OAB 13%, POP 6%, anal incontinence 25%, and 37% for any one or more disorder. Although the unadjusted prevalence of SUI, OAB, and anal incontinence increased with increasing age category, age was no longer significantly associated with the prevalence of any condition in most categories after adjustment for confounders, including obesity, birth history, menopause, and hormones. Co-occurrence of the disorders was high; roughly 80% of women with SUI or OAB, 69% with POP, and 48% with anal incontinence reported at least one other disorder. CONCLUSION: Although the prevalence of pelvic floor disorders in a community-dwelling population is high, age was not a significant contributor after adjustment for confounders. The high co-occurrence of pelvic floor disorders suggests that physicians seeing women seeking care for one condition should inquire about symptoms of other disorders.

Seeking healthcare for pelvic floor disorders: a population-based study.

OBJECTIVE: The purpose of this study was to identify characteristics that are associated with seeking care for pelvic floor disorders (PFD). STUDY DESIGN: Strategies for seeking care for pelvic organ prolapse, urinary incontinence (UI), and anal incontinence (AI) were assessed in 4392 women. Women were dichotomized into women who had sought care and women with disorders who had not. Chi-square and t tests were used to compare demographic and medical variables. Logistic regression was used to calculate adjusted odds ratios (ORs) with 95% CI. RESULTS: Women who sought care were significantly older (64 +/- 13.1 vs 55 +/- 14.8 years old; P < .001). After an adjustment for significant variables, care-seeking was associated with increasing age per year (prolapse OR, 1.07 [95% CI, 1.04-1.11]; UI OR, 1.04 [95% CI, 1.02-1.05]), hysterectomy (prolapse OR, 4.30 [95% CI, 2.16-8.55]; UI OR, 1.40 [95% CI, 1.05-1.89]), hormone replacement (UI OR, 1.78 [95% CI, 1.29-2.45]), and urinary infections (AI OR, 1.67 [95% CI, 1.04-2.68]). CONCLUSION: Seeking care for PFD is associated with older age, hysterectomy, hormone use, and frequent urinary tract infection. This reinforces the need for PFD treatment as our population ages and demand increases.

Are sexual activity and satisfaction affected by pelvic floor disorders? Analysis of a community-based survey.

OBJECTIVE: The purpose of this study was to assess the relationship between pelvic floor disorders and sexual activity and satisfaction. STUDY DESIGN: Information on pelvic floor disorders, sexual activity, and satisfaction as measured by 100-mm visual analog scale was obtained by questionnaire from 4106 women. Proportions of sexually active women were compared by the presence of each pelvic floor disorder with the use of chi-square tests. Satisfaction was compared with the use of t-tests. Logistic and linear regression analyses were used to assess the association between each pelvic floor disorder and sexual activity and satisfaction. RESULTS: Eighty-six percent of women with a partner (n = 1486) were sexually active. Women with pelvic floor disorders were less likely to be sexually active and to have lower mean satisfaction scores than unaffected women (P < .001). After regression analyses, pelvic floor disorders were not associated significantly with sexual activity or satisfaction. CONCLUSION: In community-dwelling women, sexual activity and satisfaction are independent of pelvic floor disorders.

Parity, mode of delivery, and pelvic floor disorders.

OBJECTIVE: This study aimed to assess the associations between parity, mode of delivery, and pelvic floor disorders. METHODS: The prevalence of pelvic organ prolapse, stress urinary incontinence, overactive bladder, and anal incontinence was assessed in a random sample of women aged 25-84 years by using the validated Epidemiology of Prolapse and Incontinence Questionnaire. Women were categorized as nulliparous, vaginally parous, or only delivered by cesarean. Adjusted odds ratios and 95% confidence intervals (CIs) for each disorder were calculated with logistic regression, controlling for age, body mass index, and parity. RESULTS: In the 4,458 respondents the prevalence of each disorder was as follows: 7% prolapse, 15% stress urinary incontinence, 13% overactive bladder, 25% anal incontinence, and 37% for any one or more pelvic floor disorders. There were no significant differences in the prevalence of disorders between the cesarean delivery and nulliparous groups. The adjusted odds of each disorder increased with vaginal parity compared with cesarean delivery: prolapse = 1.82 (95% CI 1.04-3.19), stress urinary incontinence = 1.81 (95% CI 1.25-2.61), overactive bladder = 1.53 (95% CI 1.02-2.29), anal incontinence = 1.72 (95% CI 1.27-2.35), and any one or more pelvic floor disorders = 1.85 (95% CI 1.42-2.41). Number-needed-to-treat analysis revealed that 7 women would have to deliver only by cesarean delivery to prevent one woman from having a pelvic floor disorder. CONCLUSION: The risk of pelvic floor disorders is independently associated with vaginal delivery but not with parity alone. Cesarean delivery has a protective effect, similar to nulliparity, on the development of pelvic floor disorders when compared with vaginal delivery. LEVEL OF EVIDENCE: II-2.

Vaginal paravaginal repair with porcine dermal reinforcement: correction of advanced anterior vaginal prolapse.

OBJECTIVE: The objective of the study was to determine the efficacy of the vaginal paravaginal repair using porcine dermal graft reinforcement for the correction of advanced anterior vaginal prolapse. STUDY DESIGN: One hundred eleven women underwent reinforced vaginal paravaginal repair between September 2001 and January 2004 and met our inclusion criteria. Postoperatively patients were evaluated at 6 weeks, 6 months, and yearly thereafter. Objective cure was defined as point Ba -1 or less. RESULTS: Eighty-nine of the 111 (80%) patients were available for follow-up. Mean age of patients was 59.5 +/- 11.6 years (range 26 to 82), mean body mass index was 29 +/- 5.5 (range 20 to 44), and median parity was 3 (range 0 to 15). Mean follow-up was 24 +/- 10.1 months (range 6 to 44) with minimum follow-up required for cure of 12 months. Overall cure rate was 78% (68 of 89). Data were analyzed using the Wilcoxon rank test. CONCLUSION: The reinforced vaginal paravaginal repair procedure is safe and effective for correction of advanced anterior vaginal prolapse.

Determinants of vaginal length.

OBJECTIVE: The purpose of this study was to describe quantitatively the associations between total vaginal length and demographic, historic, and physical characteristics. STUDY DESIGN: At 2 clinical sites, patients completed a standardized questionnaire and physical examination. Bivariate correlations explored relationships between total vaginal length and demographic, historic, and examination variables. Significant variables were evaluated with a multivariate linear regression model. RESULTS: The study included 3247 women. Hysterectomy and pelvic reconstructive surgery contribute 0.63 cm and 0.22 cm, respectively, to total vaginal length shortening; 10 years of age decreases total vaginal length by 0.08 cm. One meter of height and 10 kg of weight increases total vaginal length by 0.09 cm and 0.02 cm, respectively. Menopause is associated with a shortening of total vaginal length by 0.17 cm. CONCLUSION: Although there appears to be statistically significant associations between total vaginal length and the aforementioned factors, the impact is unlikely to be clinically significant.

Comparison of dry mouth in women treated with extended-release formulations of oxybutynin or tolterodine for overactive bladder.

The incidence, severity and tolerability of dry mouth was compared in 790 women with overactive bladder who were treated with extended-release oxybutynin chloride 10 mg/day or extended-release tolterodine tartrate 4 mg/day for 12 weeks in a multicenter, double-blind, parallel-group study. Dry mouth was the most common adverse event associated with treatment, with an incidence rate of 28.1% in the oxybutynin group and 21.6% in the tolterodine group (P = 0.039). The majority of dry mouth events were mild in both treatment groups. Severe dry mouth occurred in 1.5% and 0.5% of patients in the oxybutynin and tolterodine groups, respectively (P = 0.173). Seven patients on extended-release oxybutynin and 4 patients on extended-release tolterodine discontinued treatment due to dry mouth (P = 0.380). The results of this analysis showed that dry mouth was common with both treatments, but most events were mild; there was no difference in the rate of severe dry mouth or in the rate of withdrawal due to dry mouth.

A pilot study comparing anatomic failure after sacrocolpopexy with absorbable or permanent sutures for vaginal mesh attachment.

OBJECTIVES: To describe anatomic failure rates for sacrocolpopexy in groups receiving either delayed absorbable or permanent monofilament suture for mesh attachment to the vagina. METHODS: We reviewed the medical records of 193 women who underwent sacrocolpopexy with 2 different types of sutures attaching polypropylene mesh to the vagina: delayed absorbable sutures (median follow-up, 43 weeks) and permanent sutures (median follow-up, 106 weeks). Vaginal apical failure was defined as Point C greater than or equal to half of the total vaginal length. Anterior-posterior compartmental failures were defined as Point Ba and/or Point Bp more than 0 cm. Fisher exact and χ2 tests were used to compare failure rates. There were no documented suture erosions in the delayed absorbable monofilament suture group during the review period. Two patients in the permanent suture group were found to have permanent suture in the bladder more than 30 weeks after the index procedure. RESULTS: Failure rates for the 45 subjects in the delayed absorbable group and 148 subjects in the permanent suture group were similar (4.4% vs 3.4%, p = 0.74) and not statistically different in any compartment: apical (0% vs 1.4%, p = 0.43), anterior (4.4% vs 2%, p = 0.38), or posterior (0% vs 1.4%, p = 0.43). CONCLUSIONS: Delayed absorbable monofilament suture appears to be a reasonable alternative to permanent suture for mesh attachment to the vagina during sacrocolpopexy. The use of delayed absorbable suture could potentially prevent complications of suture erosion into the bladder or vagina remote from the time of surgery.

Robotic-assisted and laparoscopic sacrocolpopexy: comparing operative times, costs and outcomes.

OBJECTIVES: : To compare operative times, hospital costs, and surgical outcomes for robotic-assisted laparoscopic sacrocolpopexy (RALSC) and laparoscopic sacrocolpopexy (LSC). METHODS: : A retrospective cohort study of 104 subjects who underwent RALSC (n = 43) or LSC (n = 61) for vaginal vault prolapse was performed. The primary outcomes were operative time and hospital costs. The secondary outcomes included blood loss, complications, and objective cure rates. χ and t tests were used. RESULTS: : The mean operative time was longer in RALSC than in LSC (281 ± 58 vs 206 ± 42 minutes; P < 0.001) with setup time accounting for only 9 minutes of this difference. Direct costs (expressed in cost units) for hospital stay were similar (437 ± 88 vs 450 ± 119 units; P = 0.738) while surgical costs remained higher for RALSC (2724 ± 413 vs 2295 ± 342 units; P < 0.01). Blood loss and complications were similar, and objective cure was not significantly different for RALSC vs LSC (90% vs 80%, P = 0.19). CONCLUSIONS: : Robotic-assisted laparoscopic sacrocolpopexy achieves similar perioperative outcomes compared to LSC with increased surgical time resulting in increased costs.

Colporrhaphy compared with mesh or graft-reinforced vaginal paravaginal repair for anterior vaginal wall prolapse: a randomized controlled trial.

OBJECTIVE: To report 2-year outcomes of a randomized controlled trial comparing standard anterior colporrhaphy with reinforced vaginal paravaginal repair using xenograft or synthetic mesh in women with symptomatic anterior vaginal wall prolapse. METHODS: Women with stage II or greater anterior prolapse were randomly assigned to three groups: anterior colporrhaphy, paravaginal repair with porcine dermis, or polypropylene mesh. Outcomes of prolapse stage, quality of life, degree of bother, and sexual symptoms were assessed by blinded examiners and validated measures at 2 years. Anatomic failure was defined as anterior prolapse at stage II or greater. Composite failure was defined as symptoms of "bulge" and anterior prolapse at stage II or greater. Power calculations determined 33 participants per arm would detect a 40% difference in anatomic success between standard and grafted repair. χ, Mann-Whitney U, and Student's t tests were used for comparisons. RESULTS: Of the 99 participants enrolled, 78 (79%) completed a minimum of 2-year follow-up. Those with mesh had a significantly lower anatomic failure rate (18%) than both the porcine (46%, P=.015) and colporrhaphy groups (58%, P=.002). All groups had statistically similar reductions in their prolapse and urinary symptom subscale scores. Composite failure was not statistically different between groups: 13% colporrhaphy, 12% porcine, and 4% mesh. Two reoperations for anterior prolapse occurred in the porcine group. Mesh erosion rates were 14% for the mesh group. CONCLUSION: Vaginal paravaginal repair with polypropylene mesh has the lowest anatomic failure rate when compared with that with xenograft and anterior colporrhaphy without differences in composite failures. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT0139171. LEVEL OF EVIDENCE: I.

Prevalence and degree of bother from pelvic floor disorders in obese women.

We aimed to determine the prevalence and bother from pelvic floor disorders (PFD) by obesity severity, hypothesizing that both would increase with higher degrees of obesity. We performed a secondary analysis of 1,155 females enrolled in an epidemiologic study that used a validated questionnaire to identify PFD. Prevalence and degree of bother were compared across three obesity groups. Logistic regression assessed the contribution of degree of obesity to the odds of having PFD. Prevalence of any PFD was highest in morbidly (57%) and severely (53%) obese compared to obese women (44%). Regression models demonstrated higher prevalence of pelvic organ prolapse, overactive bladder, stress urinary incontinence, and any PFD in morbidly compared to obese women and higher prevalence of stress urinary incontinence in severely obese compared to obese women. Degree of bother did not vary by degree of obesity. Prevalence of PFD increases with higher degrees of obesity.

Pelvic floor disorders, diabetes, and obesity in women: findings from the Kaiser Permanente Continence Associated Risk Epidemiology Study.

OBJECTIVE: We examined associations between obesity and diabetes and female pelvic floor disorders (PFDs), stress urinary incontinence (SUI), overactive bladder (OAB), and anal incontinence (AI) in community-dwelling women. RESEARCH DESIGN AND METHODS: Women were screened for PFD using a validated mailed survey. Diabetes status, glycemic control, and diabetes treatment were extracted from clinical databases, while other risk factors for PFDs were obtained through self-report. Women were categorized hierarchically as nonobese/nondiabetic (reference), nonobese/diabetic, obese/nondiabetic, and obese/diabetic. RESULTS: Of 3,962 women, 393 (10%) had diabetes. In unadjusted analyses, women with diabetes and women who were obese had greater odds of having PFDs. Among women with diabetes, being obese was associated with SUI and OAB. After adjusting for confounders, we found that obese/diabetic women were at the highest likelihood of having SUI (odds ratio 3.67 [95% CI 2.48-5.43]) and AI (2.09 [1.48-2.97]). The odds of having OAB among obese women was the same for obese/diabetic women (2.97 [2.08-4.36]) and obese/nondiabetic women (2.93 [2.33-3.68]). Nonobese/diabetic women had higher odds of SUI (1.90 [1.15-3.11]) but did not differ significantly in their OAB (1.45 [0.88-2.38]) and AI (1.33 [0.89-2.00]) prevalence from nonobese/nondiabetic women. CONCLUSIONS: Given the impaired quality of life experienced by women with PFDs, health care providers should counsel women that obesity and diabetes may be independent modifiable risk factors for PFDs.

Elevated postvoid residual in women with pelvic floor disorders: prevalence and associated risk factors.

A retrospective case-control study was designed to assess risks for elevated post void residual (PVR) in women with pelvic floor disorders. The 1,399 women underwent evaluation including standardized questionnaire, examination, and catheterized PVR. Elevated PVR was defined as > or =100 ml and anterior and apical prolapse was defined as at or beyond the hymen. Overall, the prevalence of elevated PVR was 11%. After matching, the absence of stress incontinence symptoms (OR 0.55, CI 0.33-0.92), the symptoms of vaginal bulge (OR 2.19, CI 1.38-3.48), pelvic pressure (OR 1.79, CI 1.14-2.86), urinary splinting (OR 2.89, CI 1.24-6.74), and presence of prolapse (OR 2.60 CI 1.62-4.18) were significantly associated with an elevated PVR. Only prolapse (OR 1.96 CI 1.37-2.79) maintained a significant association after multivariate analysis. Symptoms alone do not predict which women may have an elevated PVR, but the finding of prolapse at or beyond the hymen is associated with incomplete emptying. Elevated post void residuals cannot be predicted based on symptoms alone; however, prolapse beyond the hymen may help identify women with incomplete bladder emptying.

Epidemiology of prolapse and incontinence questionnaire: validation of a new epidemiologic survey.

The epidemiology of prolapse and incontinence questionnaire (EPIQ) was developed to screen for female pelvic floor disorders (PFD). Content and face validity, reliability, internal consistency and criterion validity of the EPIQ to detect the presence of pelvic organ prolapse (POP), stress urinary incontinence (SUI), overactive bladder (OAB) and anal incontinence (AI) is presented. Cronbach's alpha; Spearman's, kappa, intraclass correlations, factor analysis and Chi-Squared tests were used for analysis. Questions related to PFD proved internally consistent (alpha = 0.91) and reproducible (correlations >0.70) for all but three items on the EPIQ. Positive and negative predictive values of the EPIQ to detect PFD were: POP = 76% and 97%, SUI = 88% and 87%, OAB = 77% and 90% and AI = 61% and 91% respectively. EPIQ is a psychometrically validated screening instrument that may identify women at high risk of having pelvic floor disorders in large undiagnosed populations.