Effects of bilateral salpingo-oophorectomy at the time of hysterectomy on pelvic organ prolapse: results from the Women's Health Initiative trial.

OBJECTIVE: This study aims to estimate the effects of bilateral salpingo-oophorectomy (BSO) at the time of hysterectomy and estrogen therapy on vaginal prolapse. METHODS: A retrospective analysis of the Women's Health Initiative estrogen-alone trial was performed. Women who retained their ovaries were compared with women who had BSO at the time of hysterectomy for the presence of cystocele or rectocele at entry into the study. Based on BSO and hormone therapy (HT) status, participants were categorized into groups. We hypothesized that BSO and prolonged hypoestrogenemia may be associated with an increased risk of prolapse. Univariate and multivariate analyses were used to determine the effects of BSO and HT status on cystocele and rectocele. RESULTS: Of 10,739 participants in the estrogen-alone trial, 8,879 women were included in the analysis. Older age, higher parity, higher body mass index, higher waist-to-hip ratio, and non-African-American race/ethnicity were associated with increased odds of developing cystocele or rectocele. Women who retained their ovaries had higher rates of cystocele or rectocele at screening (39%) compared with all women who had BSO (31-36%; odds ratio, 1.18; 95% CI, 1.04-1.33). After controlling for multiple variables, our analysis showed that women who retained their ovaries had higher odds of developing cystocele or rectocele compared with women who had BSO and no subsequent HT (odds ratio, 1.23; 95% CI, 1.07-1.41). All other comparisons were nonsignificant. CONCLUSIONS: BSO at the time of hysterectomy is not associated with increased risk of cystocele or rectocele. BSO and no subsequent HT may even have a protective effect against cystocele or rectocele.

Hysterectomy and urinary incontinence in postmenopausal women.

INTRODUCTION AND HYPOTHESIS: To evaluate an association between hysterectomy and urinary incontinence (UI) in postmenopausal women. METHODS: Women (aged 50-79) with uteri (N = 53,569) and without uteri (N = 38,524) who enrolled in the Women's Health Initiative (WHI) Observational Study between 1993 and 1996 were included in this secondary analysis. Baseline (BL) and 3-year demographic, health/physical forms and personal habit questionnaires were used. Statistical analyses included univariate and logistic regression methods. RESULTS: The baseline UI rate was 66.5 %, with 27.3 % of participants having stress urinary incontinence (SUI), 23 % having urge UI (UUI), and 12.4 % having mixed UI (MUI). 41.8 % of women had undergone hysterectomy, with 88.1 % having had the procedure before age 54. Controlling for health/physical variables, hysterectomy was associated with UI at BL (OR 1.25, 95 % CI 1.19, 1.32) and over the 3-year study period (OR 1.23, 95 % CI 1.11, 1.36). Excluding women with UI at BL, a higher incidence of UUI and SUI episodes was found in hysterectomy at year 3. Among women who had undergone hysterectomy, those with bilateral oophorectomy (BSO) did not have increased odds of developing UI at BL or over the 3-year study period. Hormone use was not associated with a change in UI incidence (estrogen + progesterone, p = 0.17; unopposed estrogen, p = 0.41). CONCLUSIONS: Risk of UI is increased in postmenopausal women who had undergone hysterectomy compared with women with uteri.

The effect of uterine fibroid embolization on lower urinary tract symptoms.

INTRODUCTION AND HYPOTHESIS: The objective was to determine the effect of uterine fibroid embolization (UFE) on lower urinary tract symptoms (LUTS) and quality of life (QoL). METHODS: This prospective study included women with symptomatic fibroids and LUTS who underwent UFE between March 2008 and May 2010. Subjects underwent pre-procedural pelvic magnetic resonance imaging (MRI) and completed the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7), Prolapse and Incontinence Sexual Questionnaire (PISQ-12), Uterine Fibroid Symptom Quality of Life questionnaire (UFS-QoL), and a standardized 48-h bladder diary at baseline and 3 months after the procedure. Patient Global Impression of Improvement (PGI-I) assessed post-procedural patient satisfaction. The primary outcome was subjective improvement in LUTS at 3 months, as measured by a decrease in UDI-6 score. Univariate analysis, paired t test and a stepwise regression analysis were appropriately conducted. RESULTS: Fifty-seven patients underwent UFE and completed bladder diaries and questionnaires. At 3 months after UFE, patients reported a significant decrease in UDI-6, IIQ-7, and UFS-QoL, indicating an improvement in urinary symptoms and QoL. Bladder diaries showed a significant reduction in daytime and night-time voids. No difference was found in incontinence episodes. Uterine volume, dominant fibroid size, fibroid location, and MRI-confirmed bladder compression did not affect the difference in UDI-6 scores. In a stepwise regression model, BMI had a significant impact on the change in UDI-6 score, with a decrease of 1.18 points for each 1 unit increase in BMI. CONCLUSION: Uterine fibroid embolization significantly improves LUTS and urinary-related QoL. Obesity seems to attenuate this effect.

Patient goal attainment in vaginal prolapse repair with and without mesh.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to describe patient-centered goals and their attainment in vaginal prolapse repair, with and without mesh. METHODS: A secondary analysis of a multicenter randomized controlled trial of prolapse repair with or without vaginal mesh was performed. Participants (n = 65) selected three preoperative goals ranked by importance. At 3 and 12 months postoperatively, patients graded their goal attainment on a scale of 1 (not at all) to 5 (100 % attainment). Goal attainment was compared with anatomical outcome, symptoms, quality of life, and satisfaction scores. Nonparametric tests and the log-rank test were used to determine statistical significance (p < 0.05). RESULTS: A total of 176 goals were selected. The first goal in 37 women (57 %) was improving prolapse symptoms, in 15 (23 %) urinary symptoms, in 7 (11 %) appearance, activity, and self-image, in 2 (3.1 %) bowel symptoms, and in 2 (3.1 %) sexual function. At 3 and 12 months postoperatively, goal achievement for prolapse symptoms was 96.1 and 93.6 %, for urinary symptoms 75.6 and 70.0 %, and for appearance, activity, and self-image 90.5 and 94.7 %, respectively. The effect of anatomical outcome, mesh use, or the presence of mesh erosion on goal attainment could not be demonstrated. Women who achieved their first goal had significantly better symptoms, quality of life, and satisfaction scores than women who did not. CONCLUSIONS: Patient goal attainment after vaginal prolapse repair was high and not consistently related to objective anatomical outcome or mesh use. It persisted between 3 and 12 months postoperatively and was associated with better satisfaction, quality of life, and symptom scores.

One-year objective and functional outcomes of a randomized clinical trial of vaginal mesh for prolapse.

OBJECTIVE: The purpose of this study was to show 12-month outcomes of a randomized trial that compared vaginal prolapse repair with and without mesh. STUDY DESIGN: Women with stage ≥2 prolapse were assigned randomly to vaginal repair with or without mesh. The primary outcome was prolapse stage ≤1 at 12 months. Secondary outcomes included quality of life and complications. RESULTS: All 65 evaluable participants were followed for 12 months after trial stoppage for mesh exposures. Thirty-two women had mesh repair; 33 women had traditional repair. At 12 months, both groups had improvement of pelvic organ prolapse-quantification test points to similar recurrence rates. The quality of life improved and did not differ between groups: 96.2% mesh vs 90.9% no-mesh subjects reported a cure of bulge symptoms; 15.6% had mesh exposures, and reoperation rates were higher with mesh. CONCLUSION: Objective and subjective improvement is seen after vaginal prolapse repair with or without mesh. However, mesh resulted in a higher reoperation rate and did not improve 1-year cure.

Vaginal mesh colpopexy for the treatment of concomitant full thickness rectal and pelvic organ prolapse: a case series.

OBJECTIVE: To present our case series of concomitant rectal and pelvic organ prolapse (POP) treated with vaginal colpopexy with synthetic mesh. STUDY DESIGN: Charts of patients with full thickness rectal prolapse and POP were reviewed for presenting symptoms, physical examination with POP-Q including rectal prolapse evaluation, and perioperative complications and outcomes. RESULTS: Four patients aged 63-78 were identified with full thickness rectal prolapse and POP. All of them had symptoms related to both conditions. Rectal prolapse protrusion ranged from 2 cm to 3 cm outside the anus. All patients had vaginal mesh colpopexy; two of them with anterior and posterior vaginal mesh and 2 with posterior mesh only. At a follow-up of 6-44 months, all patients had resolution of both POP and rectal prolapse signs and symptoms. CONCLUSION: Vaginal colpopexy with mesh may be a unique treatment to address both POP and full thickness rectal prolapse in selected patients. Further research is needed to determine the safety and efficacy of this method.

Risk factors for prolapse development in white, black, and Hispanic women.

OBJECTIVES: : This study aimed to examine the risk factors for prevalence and incidence of pelvic organ prolapse (POP) in whites, Hispanics, and blacks. METHODS: : This is a secondary analysis of the Women's Health Initiative (WHI) Estrogen plus Progestin Clinical Trial (E + P). Of the original E + P trial population of 16,608, 12,667 women (78.3%; 11,194 whites, 804 blacks, and 669 Hispanics) were included in the final study sample and evaluated during the 5-year period. The outcomes evaluated were any prolapse (WHI prolapse grades 1-3) and WHI prolapse grade 2 or 3. Descriptive analyses, logistic regression, and proportional hazard modeling were performed. RESULTS: : Increasing parity correlates with increasing WHI prolapse grades (0-3) in whites and blacks but not Hispanics. The incidence of grade 2 or 3 POP increased by 250% in white women with 1 child (hazard ratio [HR], 2.50; 95% confidence interval [CI], 1.68-3.71) in comparison to nulliparous women and grew with higher parity. For blacks, a weak association between the parity and grade 2 or 3 POP was noted only in women who had 5 or more kids (HR, 10.41; 95% CI, 1.38-78.77). Blacks were less likely (HR, 0.53; 95% CI, 0.40-0.71) to develop grade 2 or 3 POP compared with whites. For grade 2 or 3 POP, age was found to be a risk factor in whites (odds ratio [OR], 1.03; 95% CI, 1.02-1.04) only and body mass index (≥25 kg/m, <30 kg/m) in whites (OR, 1.64; 95% CI, 1.34-2.02) and Hispanics (OR, 2.87; 95% CI, 1.03-2.02). CONCLUSIONS: : White women are at a much greater risk for developing grade 2 or 3 POP compared with blacks. Parity correlates most strongly with the risk of prolapse development in whites and possibly in grand multiparous blacks.

Vaginal mesh for prolapse: a randomized controlled trial.

OBJECTIVE: To present 3-month outcomes of a double-blind, multicenter randomized controlled trial comparing traditional vaginal prolapse surgery without mesh with vaginal surgery with mesh. METHODS: Women with pelvic organ prolapse quantification prolapse stages 2-4 were randomized to vaginal colpopexy repair with mesh or traditional vaginal colpopexy without mesh. The primary outcome measure was objective treatment success (pelvic organ prolapse quantification stage 1 or lower) at 3 months. Secondary outcome measures included quality-of-life variables and complication rates. RESULTS: Sixty-five women were recruited from January 2007 to August 2009, when the study was halted due to predetermined stopping criteria for vaginal mesh erosion at a median follow-up of 9.7 months (range, 2.4-26.7 months). Thirty-two women underwent mesh colpopexy (24 anterior mesh, eight total mesh), and 33 women had vaginal colpopexies without mesh (primarily uterosacral ligament suspension) and concurrent colporrhaphy. There were no statistically significant baseline differences between the mesh and no-mesh groups with respect to demographics, menopausal status, and race. Analysis of the mesh and no-mesh women found no difference with respect to overall recurrence (mesh: 19 [59.4%] compared with no mesh: 24 [70.4%], P=.28). There were five (15.6%) vaginal mesh erosions. Two cystotomies and one blood transfusion occurred in the mesh group only. Subjective cure of bulge symptoms was noted in 93.3% of mesh patients and 100% of no-mesh patients. Furthermore, subjective quality-of-life measurements did not differ between the two groups at baseline or 3 months postoperatively. CONCLUSION: At 3 months, there is a high vaginal mesh erosion rate (15.6%) with no difference in overall objective and subjective cure rates. This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540. LEVEL OF EVIDENCE: I.

Posterior wall prolapse and repair.

Most posterior wall defects occur in combination with other pelvic support disorders. Some patients with rectoceles, the most common posterior wall defect, are asymptomatic, whereas others experience a range of symptoms from a sensation of lower pelvic fullness to defecatory and/or sexual dysfunction. If patients are symptomatic, rectoceles can be treated conservatively with pelvic floor physiotherapy, behavioral therapy, or pessaries. Surgically, the most common rectocele repair is a traditional posterior colporrhaphy which provides excellent cure rates of up to 95%. The studies published to date do not support the use of biologic or synthetic absorbable grafts in reconstructive surgical procedures of the posterior compartment as these repairs have not improved anatomic or functional outcomes over traditional posterior colporrhaphy.

A comparison of transobturator versus retropubic midurethral slings for mixed urinary incontinence.

PURPOSE: : The primary objective of this study was to compare improvement and/or cure of mixed urinary incontinence (MUI) symptoms after retropubic (RP) versus transobturator (TO) slings. The secondary objective was to compare improvement and/or cure of the urge urinary incontinence (UUI) component of MUI. METHODS: : This retrospective cohort study included all patients with MUI who underwent a midurethral sling from January 2006 to May 2007. IRB approval was obtained to perform telephone interviews to collect the Patient Global Impression of Improvement (PGI-I) questionnaire for MUI and to elicit any changes in the SUI and/or UUI components of MUI. The primary outcome was based on a 7-point Likert scale for the PGI-I questionnaire. The secondary outcome was improvement or resolution of the UUI component of MUI based on a 4-point Likert scale of patient responses to the question, "Is your urge incontinence worse, the same, or improved after surgery?" Subjects who had RP slings were compared with those with TO with respect to these outcomes. Patient satisfaction, adverse events, urinary retention, and worsening of urge incontinence symptoms were also assessed. RESULTS: : For the primary outcome (MUI), no significant difference was found in the PGI-I scores between the 2 groups. Similarly, no difference was found in UUI improvement/resolution between the 2 groups. UUI improvement was noted in 46.4% of the TO group and 56.5% of the RP group, and UUI cure in 39.3% of the TO group and 26.1% of the RP group. An 84.3% overall improvement/cure rate of UUI was noted when both groups were combined. Ten (19.6%) women required anticholinergic use after slings. A total of 52.6% of subjects were "completely satisfied" and 14.3% were "not at all satisfied" with the procedure in the TO group, versus 65.2% and 7.7% in the RP group (Mann-Whitney U test, P = 0.23). There was no difference in perioperative adverse events between the 2 groups. CONCLUSIONS: : RP and TO slings result in similar global improvement in MUI symptoms. A total of 84.3% of patients undergoing RP or TO sling for MUI have improvement/cure of the UUI component.

Robotic sacrocolpopexy versus vaginal colpopexy with mesh: choosing the right surgery for anterior and apical prolapse.

OBJECTIVES: : To describe patients' characteristics and anatomic outcome of robotic sacrocolpopexy (RSC) and vaginal mesh colpopexy (VMC). METHODS: : Retrospective cohort study involving RSC (n = 17) and VMC (n = 37) procedures performed over an 18 month period in a teaching hospital. The primary outcome was 1 year anatomic cure at the apex and anterior wall. Descriptive and univariate analyses were used to determine statistical significance (P < 0.05). RESULTS: : VMC subjects were more likely to be older, menopausal, and had increased BMI and more severe prolapse than the RSC group. At a mean follow-up of 13 and 12.3 months for the VMC and RSC, respectively, both groups showed significant improvement of prolapse (P < 0.001) with a cure rate of 94.1% for RSC and 70.2% for VMC (P = 0.07). Total vaginal length was significantly shorter after VMC. RSC had longer operative time and hospital stay, but lower blood loss. Complication rates were similar among the groups. CONCLUSIONS: : RSC and VMC are being offered to different patient populations. These minimally invasive prolapse repair procedures have comparable results with a trend toward higher cure rate in RSC and similar complications rate.

The effect of voiding mechanism on success rates of midurethral sling procedures for stress urinary incontinence.

OBJECTIVE: : To evaluate the effect of voiding mechanism on cure rate of stress urinary incontinence in patients undergoing midurethral sling procedures. METHODS: : Retrospective study of 121 patients who underwent midurethral sling procedures (retropubic or transobturator [TO]) between January 2006 and October 2007. Voiding mechanism was determined by preoperative pressure flow studies. Subjects were dichotomized to either "detrusor voiders" (N = 61) or "Valsalva voiders" (N = 60). Primary outcome was cure of stress urinary incontinence. RESULTS: : At a mean follow-up of 6.74 months, the overall success rate was 87.6% (85.7% for retropubic and 89.4% for TO). "Valsalva voiders" had a higher risk of failure compared with "detrusor voiders" (20% vs. 4.9%, respectively; OR = 4.83, 95% CI: 1.29, 18.12, P = 0.012). This effect was significant for TO slings (P = 0.025); however, sling type was not an independent predictor of failure. CONCLUSIONS: : Valsalva voiding mechanism is associated with an increased risk of failure of synthetic midurethral slings.

Effect of weight change on natural history of pelvic organ prolapse.

OBJECTIVE: To evaluate the relationship between change in weight and pelvic organ prolapse (POP) progression/regression in women during a 5-year period. METHODS: Postmenopausal women with uteri (N=16,608), ages 50 to 79, who were enrolled in the Women's Health Initiative (WHI) Estrogen plus Progestin Clinical Trial between 1993 and 1998 were included in this secondary analysis. Baseline pelvic examination, repeated annually, assessed uterine prolapse, cystocele, and rectocele using the WHI Prolapse Classification System. Statistical analyses included univariate and multiple logistic regression methods. RESULTS: During the 5-year time period, the majority of women (9,251, 55.7%) gained weight (mean 4.43 kg, +/-5.95 kg), and the overall rate of prolapse (WHI Prolapse Classification System: grades 1-3) increased from 40.9% at baseline to 43.8% at year 5 of evaluation. Controlling for age, parity, race, and other health/physical variables, being overweight (body mass index [BMI] between 25 and 29.9) or obese (BMI of at least 30) at baseline was associated with progression in cystocele, rectocele, and uterine prolapse compared with women with healthy BMIs (BMI is calculated as weight (kg)/[height (m)]). Specifically, the risk of prolapse progression in overweight and obese women as compared with the participants with healthy BMIs increased by 32% and 48% for cystocele, by 37% and 58% for rectocele, and by 43% and 69% for uterine prolapse, respectively. Adjusting for women with prolapse at baseline and baseline BMI, a 10% weight change was associated with minimal change in overall POP. Specifically, a 10% weight loss was associated with a borderline worsening of uterine prolapse (odds ratio [OR] 0.93, 95% confidence interval [CI] 0.88-0.97) and a minimal regression of cystocele (OR 1.03, 95% CI 1.00-1.05) and rectocele (OR 1.04, 95% CI 1.01-1.07). CONCLUSION: Being overweight or obese is associated with progression of POP. Weight loss does not appear to be significantly associated with regression of POP, suggesting that damage to the pelvic floor related to weight gain might be irreversible. LEVEL OF EVIDENCE: II.