Karl M. Luber

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

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 &khgr;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. LEVEL OF EVIDENCE: II

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

Introduction and hypothesisThe 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.MethodsThis 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.ResultsOf 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.ConclusionBased 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.

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.

Pelvic Floor Disorders, Diabetes Mellitus, and Obesity in Women: Findings from the KP CARES 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.

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. &khgr;2, Mann-Whitney U, and Students 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

Efficacy of functional electrical stimulation in treating genuine stress incontinence: A randomized clinical trial

Our objective was to determine the efficacy of functional electrical stimulation as a stand‐alone therapy for female stress incontinence. The study was conducted as a prospective, double‐blind, randomized controlled trial using subjective and objective outcome criteria. Patients enrolled in this study had stress incontinence consistent with International Continence Society criteria. Patients with significant pelvic prolapse or detrusor instability were excluded. Patients underwent twice‐daily treatment sessions for a total of 3 months. Results were analyzed for confounding variables between the treatment and control groups. Statistical analysis was performed utilizing Fishers exact test and the paired t‐test. Of the 54 patients enrolled in this study, 44 completed the program. The dropout rate was similar for both the treatment and control groups. There was no statistically significant difference between the treatment and control groups with regard to age, gravity, parity, previous antiincontinence surgery, menopausal status, or previous hysterectomy. Objective success for the treatment group was 15% and for the control group, 12.5% (NS). The subjective success for the treatment group was 25% and for the control group, 29% (NS). There was no relationship demonstrated between age, parity, previous surgery, hysterectomy, or menopausal status and the successful treatment of genuine stress incontinence with functional electrical stimulation. In this patient population, functional electrical stimulation was no more effective at improving or eliminating the symptoms of genuine stress incontinence than was the daily retention of the control probe. Neurourol. Urodynam. 16:543–551, 1997.

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.

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. &khgr;2 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.

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.