Open sacrocolpopexy and vaginal apical repair: retrospective comparison of success and serious complications.

INTRODUCTION AND HYPOTHESIS: We compared treatment success and adverse events between women undergoing open abdominal sacrocolpopexy (ASC) vs vaginal repair (VAR) using data from women enrolled in one of three multicenter trials. We hypothesized that ASC would result in better outcomes than VAR. METHODS: Participants underwent apical repair of stage 2-4 prolapse. Vaginal repair included uterosacral, sacrospinous, and iliococcygeal suspensions; sacrocolpopexies were via laparotomy. Success was defined as no bothersome bulge symptoms, no prolapse beyond the hymen, and no retreatment up to 24 months. Adverse events were collected at multiple time points. Outcomes were analyzed using longitudinal mixed-effects models to obtain valid outcome estimates at specific visit times, accounting for data missing at random. Comparisons were controlled for center, age, body mass index (BMI), initial Pelvic Organ Prolapse Quantification (POP-Q) stage, baseline scores, prior prolapse repair, and concurrent repairs. RESULTS: Of women who met inclusion criteria (1022 of 1159 eligibile), 701 underwent vaginal repair. The ASC group (n = 321) was older, more likely white, had prior prolapse repairs, and stage 4 prolapse (all p < 0.05). While POP-Q measurements and symptoms improved in both groups, treatment success was higher in the ASC group [odds ratio (OR) 6.00, 95% confidence interval (CI) 3.45-10.44). The groups did not differ significantly in most questionnaire responses at 12 months and overall improvement in bowel and bladder function. By 24 months, fewer patients had undergone retreatment (2% ASC vs 5% VAR); serious adverse events did not differ significantly through 6 weeks (13% vs 5%, OR 2.0, 95% CI 0.9-4.7), and 12 months (26% vs 13%, OR 1.6, 95% CI 0.9-2.9), respectively. CONCLUSIONS: Open sacrocolpopexy resulted in more successful prolapse treatment at 2 years.

Surgical Outcomes After Apical Repair for Vault Compared With Uterovaginal Prolapse.

OBJECTIVE: To retrospectively compare surgical success and complications between vaginal vault prolapse compared with uterovaginal prolapse in women who underwent apical prolapse repair for stage II-IV prolapse. METHODS: Women in one of three Pelvic Floor Disorders Network prolapse surgical trials were included. Absence of bothersome bulge symptoms, no prolapse beyond the hymen, and no subsequent prolapse treatment defined success and was our primary outcome. Secondary outcomes included comparison of quality-of-life measures, anatomic changes, and adverse events. Pelvic organ prolapse quantification (POP-Q) and quality-of-life measures were administered at baseline and 1-2 years postoperatively. Comparisons were controlled for study site, age, body mass index, baseline POP-Q, apical and anterior or posterior repair performed, and prior prolapse repair. Outcomes measured at multiple time points were analyzed using longitudinal models to assess whether differences existed across study follow-up. RESULTS: Four hundred twenty-one women underwent vault prolapse, and 601 underwent uterovaginal prolapse apical repair. The vault prolapse group was older, more likely to be white, and to have prior urinary incontinence or prolapse repair, stage IV prolapse, and more prolapse bother on a validated scale (all P≤.034). The vault prolapse group was more likely to undergo sacrocolpopexy (228/421 [54%] vs 93/601 [15%]); the uterovaginal prolapse group was more likely to undergo vaginal repair (508/601 [85%] vs 193/421 [46%] P<.001). There were no differences in success (odds ratio [OR] 0.76 for vault prolapse vs uterovaginal prolapse, 95% CI 0.51-1.15, P=.20), changes in Pelvic Organ Prolapse Distress Inventory scores (-79.4 vs -79.8, P=.89), postoperative POP-Q point C measurements (-7.0 vs -7.1 cm, P=.41), or serious adverse events (86/421 [20%] vs 90/601 [15%], P=.86) between groups. Among women who underwent a vaginal approach for repair of vault prolapse (n=193) or uterovaginal prolapse (n=508), there were no differences in success rates (OR 0.67, 95% CI 0.43-1.04, P=.09) at 1-2 years postoperatively. CONCLUSION: Surgical success of stage II-IV vault prolapse and uterovaginal prolapse apical repair was similar whether performed vaginally or abdominally at 1-2 years postoperatively.

Variables Affecting Intra-abdominal Pressure During Lifting in the Early Postpartum Period.

OBJECTIVES: Intra-abdominal pressure (IAP) may contribute to pelvic floor health, although the direction and magnitude of such an effect, if any, are not yet known. Identifying individual characteristics, and in particular modifiable factors, associated with higher IAP during recovery from vaginal childbirth might serve to mitigate early pelvic floor dysfunction. The aim of this study was to identify characteristics associated with maximal IAP during lifting in postpartum primiparous women who delivered vaginally. METHODS: At 6 to 10 weeks postpartum, we measured maximal IAP, assessed via an upper vaginal sensor, as participants (enrolled in an ongoing cohort study) lifted a weighted car seat (12.5 kg). We evaluated whether the following independent variables were associated with maximal IAP: age, ethnicity, body mass index, height, abdominal circumference, weight gain during pregnancy, lifting time, breath holding during lifting, lifting technique, measures of muscular fitness, and days since delivery. RESULTS: In the 206 participants, weight, waist circumference, body mass index, and days since delivery were positively associated with mean maximal IAP during lifting, whereas IAP decreased as height increased. As the duration of the lifting task increased, mean maximal IAP during lifting also increased, but there were no associations between lifting technique or breath holding during lifting and IAP. Neither pelvic floor muscle strength nor abdominal muscle endurance was associated with IAP during lifting. CONCLUSIONS: Other than measures of body habitus and lifting duration, we did not identify modifiable factors that could mitigate maximal pressures experienced by the pelvic floor during the early postpartum period.

Perioperative Behavioral Therapy and Pelvic Muscle Strengthening Do Not Enhance Quality of Life After Pelvic Surgery: Secondary Report of a Randomized Controlled Trial.

BACKGROUND: There is significant need for trials evaluating the long-term effectiveness of a rigorous program of perioperative behavioral therapy with pelvic floor muscle training (BPMT) in women undergoing transvaginal reconstructive surgery for prolapse. OBJECTIVE: The purpose of this study was to evaluate the effect of perioperative BPMT on health-related quality of life (HRQOL) and sexual function following vaginal surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). DESIGN: This study is a secondary report of a 2 × 2 factorial randomized controlled trial. SETTING: This study was a multicenter trial. PARTICIPANTS: Participants were adult women with stage 2-4 POP and SUI. INTERVENTION: Perioperative BPMT versus usual care and sacrospinous ligament fixation (SSLF) versus uterosacral ligament suspension (ULS) were provided. MEASUREMENTS: Participants undergoing transvaginal surgery (SSLF or ULS for POP and a midurethral sling for SUI) received usual care or five perioperative BPMT visits. The primary outcome was change in body image and in Pelvic Floor Impact Questionnaire (PFIQ) short-form subscale, 36-item Short-Form Health Survey (SF-36), Pelvic Organ Prolapse-Urinary Incontinence Sexual Questionnaire short form (PISQ-12), Patient Global Impression of Improvement (PGII), and Brink scores. RESULTS: The 374 participants were randomized to BPMT (n = 186) and usual care (n = 188). Outcomes were available for 137 (74%) of BPMT participants and 146 (78%) of the usual care participants at 24 months. There were no statistically significant differences between groups in PFIQ, SF-36, PGII, PISQ-12, or body image scale measures. LIMITATIONS: The clinicians providing BPMT had variable expertise. Findings might not apply to vaginal prolapse procedures without slings or abdominal apical prolapse procedures. CONCLUSIONS: Perioperative BPMT performed as an adjunct to vaginal surgery for POP and SUI provided no additional improvement in QOL or sexual function compared with usual care.

Physical and cultural determinants of postpartum pelvic floor support and symptoms following vaginal delivery: a protocol for a mixed-methods prospective cohort study.

INTRODUCTION: Pelvic floor disorders (PFDs), including pelvic organ prolapse (POP), stress and urgency urinary incontinence, and faecal incontinence, are common and arise from loss of pelvic support. Although severe disease often does not occur until women become older, pregnancy and childbirth are major risk factors for PFDs, especially POP. We understand little about modifiable factors that impact pelvic floor function recovery after vaginal birth. This National Institutes of Health (NIH)-funded Program Project, 'Bridging physical and cultural determinants of postpartum pelvic floor support and symptoms following vaginal delivery', uses mixed-methods research to study the influences of intra-abdominal pressure, physical activity, body habitus and muscle fitness on pelvic floor support and symptoms as well as the cultural context in which women experience those changes. METHODS AND ANALYSIS: Using quantitative methods, we will evaluate whether pelvic floor support and symptoms 1 year after the first vaginal delivery are affected by biologically plausible factors that may impact muscle, nerve and connective tissue healing during recovery (first 8 weeks postpartum) and strengthening (remainder of the first postpartum year). Using qualitative methods, we will examine cultural aspects of perceptions, explanations of changes in pelvic floor support, and actions taken by Mexican-American and Euro-American primipara, emphasising early changes after childbirth. We will summarise project results in a resource toolkit that will enhance opportunities for dialogue between women, their families and providers, and across lay and medical discourses. We anticipate enrolling up to 1530 nulliparous women into the prospective cohort study during the third trimester, following those who deliver vaginally 1 year postpartum. Participants will be drawn from this cohort to meet the project's aims. ETHICS AND DISSEMINATION: The University of Utah and Intermountain Healthcare Institutional Review Boards approved this study. Data are stored in a secure password-protected database. Papers summarising the primary results and ancillary analyses will be published in peer-reviewed journals.

Reproducibility of intra-abdominal pressure measured during physical activities via a wireless vaginal transducer.

AIMS: In the urodynamics laboratory setting, a wireless pressure transducer, developed to facilitate research exploring intra-abdominal pressure (IAP) and pelvic floor disorders, was highly accurate. We aimed to study reproducibility of IAP measured using this transducer in women during activities performed in an exercise science laboratory. METHODS: Fifty-seven women (mean ± SD, age 30.4 ±9.3 years; body mass index, 22.4 ± 2.68 kg/m) completed 2 standardized activity sessions using the same transducer at least 3 days apart. Pressure data for 31 activities were transmitted wirelessly to a base station and analyzed for mean net maximal IAP, area under the curve, and first moment of the area. Activities included typical exercises, lifting 13.6 to 18.2 kg, and simulated household tasks. Analysis for test-retest reliability included Bland-Altman plots with absolute limits of agreement, Wilcoxon signed rank tests to assess significant differences between sessions, intraclass correlations, and κ statistics to assess intersession agreement in highest versus other quintiles of maximal IAP. RESULTS: Few activities exhibited significant differences between sessions in maximal IAP, or in area under the curve and first moment of the area values. For 13 activities, the agreement between repeat measures of maximal IAP was better than ±10 cm H20; for 20 activities, better than ±15 cm H20. The absolute limits of agreement increased with mean IAP. The highest quintile of IAP demonstrated fair/substantial agreement between sessions in 25 of 30 activities. CONCLUSIONS: Reproducibility of IAP depends on the activity undertaken. Interventions geared toward lowering IAP should account for this, maximize efforts to improve IAP reproducibility.

Effects of walking speeds and carrying techniques on intra-abdominal pressure in women.

INTRODUCTION AND HYPOTHESIS: Walking speed and carrying technique affect intra-abdominal pressure (IAP) in women. In this study, we tested the feasibility of monitoring IAP outside the laboratory environment and compared IAP while study participants were (1) carrying 13.6 kg (similar to a 3-month old in car seat) in six different ways while walking 100 m; and (2) while walking 400 m at self-selected slow, normal, and fast paces. METHODS: Forty-six healthy women between 19 and 54 years completed the walking and lifting activities; the order for each was randomized. IAP was monitored with an intravaginal pressure transducer that wirelessly transmitted pressure data to a portable base station. We analyzed maximal peak IAP and area under the curve (AUC) IAP. RESULTS: Monitoring IAP outside of the laboratory was feasible. Mean maximal IAP during walking increased as pace increased: 42.5 [standard deviation (SD) 10.2], 50.5 (10.9), and 62.0 (12.1) cmH2O for slow, medium, and fast speeds, respectively: p < 0.0001 by mixed-model analysis of variance (ANOVA). The corresponding AUC of IAP for walking decreased as pace increased. The awkward carry, side carry, and front carry activities each resulted in higher mean maximal IAP [65.8 (10.6), 67.7 (12.8), and 77.3 (13.1) cmH2O, respectively] than the carry-in-backpack activity [55.5 (11.4) cmH2O; p < 0.0001]. CONCLUSION: Subtle variations in walking speed or method of carrying a toddler-size load can produce significant changes in IAP. Whether these changes increase the risk of pelvic floor disorders is not yet clear. However, these data suggest that further inquiry into optimal methods and appliances to assist women in carrying may create a lower IAP profile.

Allogeneic stem cell transplant in patients with chronic lymphocytic leukemia with 17p deletion: consult-transplant versus consult- no-transplant analysis.

Allogeneic stem cell transplant (alloSCT) can overcome the adverse prognosis of chronic lymphocytic leukemia with 17p deletion (17p- CLL). However, its applicability remains unclear. Since 2007, our leukemia service has referred patients with 17p- CLL for alloSCT at presentation. In this study, the outcomes of these patients were reviewed retrospectively to determine whether they underwent alloSCT and why patients did not undergo alloSCT. Fifty-two patients with 17p- CLL who were referred to the transplant service from 2007 to 2010 were identified. Of these patients, 32 (62%) did not undergo alloSCT, mainly because of treatment- or disease-related complications (n = 15). The 2-year post-referral overall survival rates of the alloSCT and non-SCT groups were 64% and 25%, respectively (p = 0.001). These findings suggest that while alloSCT is an effective therapy in patients with 17p- CLL, pre-SCT complications may preclude a significant proportion of patients from undergoing the procedure.

Effectiveness of blinding: sham suprapubic incisions in a randomized trial of retropubic midurethral sling in women undergoing vaginal prolapse surgery.

OBJECTIVE: This planned secondary analysis of the Outcomes Following Vaginal Prolapse Repairs and Midurethral Sling trial assessed whether treatment knowledge differed between randomized groups at 12 months and whether treatment success was affected by treatment perception. STUDY DESIGN: Sham suprapubic tension-free vaginal tape (TVT) incisions were made in the Outcomes Following Vaginal Prolapse Repairs and Midurethral Sling trial participants randomized to no-TVT. Primary surgical outcomes and maintenance of blinding was assessed at 12 months. Knowledge of treatment assignment was compared between groups, and the relationship with treatment success rates was assessed. RESULTS: Prior to the 12 month postoperative visit, only 4% of treated participants (13 of 336) formally reported unmasking. At 12 months, 94% of the randomized participants (315 of 336) provided treatment knowledge data. Sixteen TVT participants (10%) reported treatment knowledge; most (n = 15, 94%) were correct; 17 of the sham participants (11%) reported treatment knowledge; half (n = 8, 47%) were correct. Similar proportions of unmasked participants who reported no treatment knowledge correctly guessed/perceived treatment assignment (sham, 46 [33%] vs TVT, 44 [33%]). We did not detect significant differences in treatment success rates based on perception within and across received treatment groups (perceived sham vs TVT overall [P = .76]). Of those receiving TVT, more participants perceiving TVT had treatment success compared with those who perceived sham (84% vs 74%; P = .29). Among sham participants, more participants perceiving sham had success compared with those who perceived receiving TVT (65% vs 56%; P = .42). CONCLUSION: Sham surgical incisions effectively mask TVT randomization. These findings may help to inform future surgical trial designs.

Changed women: the long-term impact of vaginal mesh complications.

OBJECTIVES: The aim of this study was to describe how women experience vaginal mesh complications after optimized tertiary care level treatment. METHODS: We conducted telephone interviews in 2012 with women at least 6 months after presentation to our tertiary care clinic between 2006 and 2011 for complications related to vaginal mesh and transcribed verbatim responses to 2 open-ended questions about their experiences surrounding vaginal mesh complications. We analyzed data using qualitative description with low-inference interpretation in a team-based setting followed by consensus meetings to arrive at descriptive trajectories of their experiences. RESULTS: Of 111 women, we successfully contacted 88, and 84 agreed to the interview. The mean duration from index mesh surgery to interview was 4.5 years, and the mean duration from presentation to our clinic for complications to the interview was 2.3 years. The effects of mesh complications caused both physical and emotional pain, in addition to the discomfort of the original pelvic floor dysfunction. The women's experiences followed 1 of 3 recovery trajectories. In "cascading health problems," the women experienced a spiral of health problems, anxiety, and desperation. In "settling for a new normal," the women who once considered themselves healthy now believed that they are unhealthy and worked to adjust to their degraded health status. In "returning to health," the women described a return to health. The women still symptomatic discharged from tertiary care clinic expressed hopelessness and abandonment. CONCLUSIONS: Concomitant with ongoing research to improve the safety of vaginal mesh procedures, there must be dedicated efforts to develop and study a range of therapies for holistically treating women with mesh complications.

Long-term follow-up of treatment for synthetic mesh complications.

OBJECTIVES: The objectives of this study are (1) to describe the presenting symptoms, findings, and treatment and (2) to describe the self-reported improvement and function at least 6 months after presentation in women presenting to 1 urogynecology division for complications associated with synthetic vaginal mesh. METHODS: Women evaluated between 2006 and 2011 were identified by diagnostic codes. We abstracted information from the medical record and attempted to contact all women to complete a follow-up telephone survey questionnaire consisting of several validated instruments. RESULTS: A total of 111 women were evaluated for complications associated with synthetic vaginal mesh. The mean interval from index surgery was 2.4 years. Of these, 84% were referred from outside hospitals. Index surgeries included vaginal mesh kits/vaginally placed mesh (47%), midurethral mesh slings (37%), abdominally placed vaginal mesh (11%), and vaginal mesh kit with concomitantly placed mesh sling (5%). The most common complications were extrusion (65%), contraction (17%), and chronic pelvic pain (16%). A total of 98 women underwent some type of treatment (85 surgical) by urogynecologists, pelvic pain specialists, or physical therapists. Eighty-four (76%) provided follow-up information at mean interval since presentation of 2.3 years. At follow-up, the mean (SD) Pelvic Floor Distress Inventory score was 98 (67), the mean (SD) EQ-5D index score was 0.69 (0.23), and 22% reported vaginal discharge, 15% vaginal bleeding or spotting, and 45% sexual abstinence due to problems related to mesh. A total of 71% reported being overall better, whereas 29% were the same or worse. CONCLUSIONS: Two years after tertiary care level multidisciplinary treatment of vaginal mesh complications, many women still report symptoms that negatively impact their quality of life.

Intra-abdominal pressures during activity in women using an intra-vaginal pressure transducer.

Strenuous physical activity has been linked to pelvic floor disorders in women. Using a novel wireless intra-vaginal pressure transducer, intra-abdominal pressure was measured during diverse activities in a laboratory. Fifty-seven women performed a prescribed protocol using the intra-vaginal pressure transducer. We calculated maximal, area under the curve and first moment of the area intra-abdominal pressure for each activity. Planned comparisons of pressure were made between levels of walking and cycling and between activities with reported high pressure in the literature. Findings indicate variability in intra-abdominal pressure amongst individuals doing the same activity, especially in activities that required regulation of effort. There were statistically significant differences in maximal pressure between levels of walking, cycling and high pressure activities. Results for area under the curve and first moment of the area were not always consistent with maximal pressure. Coughing had the highest maximal pressure, but had lower area under the curve and first moment of the area compared to most activities. Our data reflect novel findings of maximal, area under the curve and first moment of the area measures of intra-abdominal pressure, which may have clinical relevance for how physical activity relates to pelvic floor dysfunction.

Risk factors for urgency incontinence in women undergoing stress urinary incontinence surgery.

Objective. To determine baseline variables associated with urgency urinary incontinence (UUI) in women presenting for stress urinary incontinence (SUI) surgery. Methods. Baseline data from two randomized trials enrolling 1,252 women were analyzed: SISTEr (fascial sling versus Burch colposuspension) and TOMUS (retropubic versus transobturator midurethral sling). Demographic data, POP-Q measures, and validated measures of symptom severity and quality of life were collected. Charlson Comorbidity Index (CCI) and Patient Health Questionnaire-9 were measured in TOMUS. Multivariate models were constructed with UUI and symptom severity as outcomes. Results. Over two-thirds of subjects reported bothersome UUI at baseline. TOMUS patients with more comorbidities had higher UDI irritative scores (CCI score 0 = 39.4, CCI score 1 = 42.1, and CCI score 2+ = 51.0, P = 0.0003), and higher depression scores were associated with more severe UUI. Smoking, parity, prior incontinence surgery/treatment, prolapse stage, and incontinence episode frequency were not independently associated with UUI. Conclusions. There were no modifiable risk factors identified for patient-reported UUI in women presenting for SUI surgery. However, the direct relationships between comorbidity level, depression, and worsening of UUI/urgency symptoms may represent targets for preoperative intervention. Further research is necessary to elucidate the pathophysiologic mechanisms that explain the associations between these medical conditions and bladder function.

A novel technique to measure in vivo uterine suspensory ligament stiffness.

OBJECTIVE: The purpose of this study was to describe a new computer-controlled research apparatus for measuring in vivo uterine ligament force-displacement behavior and stiffness and to present pilot data for women with and without prolapse. STUDY DESIGN: Seventeen women with varying uterine support underwent testing in the operating room (OR) after anesthetic induction. A tripod-mounted computer-controlled linear servoactuator was used to quantify force-displacement behavior of the cervix and supporting ligaments. The servoactuator applied a caudally directed force to a tenaculum at 4 mm/sec velocity until the traction force reached 17.8 N (4 lbs). Cervix location on Pelvic Organ Prolapse Quantification system (POP-Q) in the clinic, in the OR, at rest, and with minimal force (<1.1 N); maximum force (17.8 N) was recorded. Ligament "stiffness" between minimum and maximum force was calculated. RESULTS: The mean ± SD subject age was 54.5 ± 12.7 years; parity was 2.9 ± 1.1; body mass index was 29.0 ± 4.3 kg/m(2), and POP-Q point C was -3.1 ± 3.9 cm. POP-Q point C was correlated most strongly with cervix location at maximum force (r = +0.68; P = .003) and at rest (r = +0.62; P = .009). Associations between cervix location at minimum force (r = +0.46; P = .059) and ligament stiffness (r = -0.44; P = .079) were not statistically significant. Cervix location in the OR with minimal traction lay below the lowest point found on POP-Q for 13 women. CONCLUSION: POP-Q point C was correlated strongly with cervix location at rest and at maximum traction force; however, only 19% of the variation in POP-Q point C location was explained by ligament stiffness. The cervix location in the OR at minimal traction lay below POP-Q point C value in three-fourths of the women.

More complicated than it looks: the vagaries of calculating intra-abdominal pressure.

Activities thought to induce high intra-abdominal pressure (IAP), such as lifting weights, are restricted in women with pelvic floor disorders. Standardized procedures to assess IAP during activity are lacking and typically only focus on maximal IAP variably defined. Our intent in this methods article is to establish the best strategies for calculating maximal IAP and to add area under the curve and first moment of the area as potentially useful measures in understanding biologic effects of IAP. Thirteen women completed a range of activities while wearing an intravaginal pressure transducer. We first analyzed various strategies heuristically using data from 3 women. The measure that seemed to best represent maximal IAP was an average of the 3, 5, or 10 highest values, depending on activity, determined using a top-down approach, with peaks at least 1 second apart using algorithms written for Matlab computer software, we then compared this strategy with others commonly reported in the literature quantitatively using data from 10 additional volunteers. Maximal IAP calculated using the top-down approach differed for some, but not all, activities compared with the single highest peak or to averaging all peaks. We also calculated area under the curve, which allows for a time component, and first moment of the area, which maintains the time component while weighing pressure amplitude. We validated methods of assessing IAP using computer-generated sine waves. We offer standardized methods for assessing maximal area under the curve and first moment of the area for IAP to improve future reporting and application of this clinically relevant measure in exercise science.

Adherence to behavioral interventions for stress incontinence: rates, barriers, and predictors.

BACKGROUND: First-line conservative treatment for stress urinary incontinence (SUI) in women is behavioral intervention, including pelvic-floor muscle (PFM) exercise and bladder control strategies. OBJECTIVE: The purposes of this study were: (1) to describe adherence and barriers to exercise and bladder control strategy adherence and (2) to identify predictors of exercise adherence. DESIGN: This study was a planned secondary analysis of data from a multisite, randomized trial comparing intravaginal continence pessary, multicomponent behavioral therapy, and combined therapy in women with stress-predominant urinary incontinence (UI). METHODS: Data were analyzed from the groups who received behavioral intervention alone (n=146) or combined with continence pessary therapy (n=150). Adherence was measured during supervised treatment and at 3, 6, and 12 months post-randomization. Barriers to adherence were surveyed during treatment and at the 3-month time point. Regression analyses were performed to identify predictors of exercise adherence during supervised treatment and at the 3- and 12-month time points. RESULTS: During supervised treatment, ≥86% of the women exercised ≥5 days a week, and ≥80% performed at least 30 contractions on days they exercised. At 3, 6, and 12 months post-randomization, 95%, 88%, and 80% of women, respectively, indicated they were still performing PFM exercises. During supervised treatment and at 3 months post-randomization, ≥87% of the women reported using learned bladder control strategies to prevent SUI. In addition, the majority endorsed at least one barrier to PFM exercise, most commonly "trouble remembering to do exercises." Predictors of exercise adherence changed over time. During supervised intervention, less frequent baseline UI and higher baseline 36-Item Short-Form Health Survey (SF-36) mental scores predicted exercise adherence. At 3 months post-randomization, women who dropped out of the study had weaker PFMs at baseline. At 12 months post-randomization, only "trouble remembering" was associated with exercise adherence. LIMITATIONS: Adherence and barrier questionnaires were not validated. CONCLUSIONS: Adherence to PFM exercises and bladder control strategies for SUI can be high and sustained over time. However, behavioral interventions to help women link exercise to environmental and behavioral cues may only be beneficial over the short term.

Pelvic floor disorders clinical trials: participant recruitment and retention.

INTRODUCTION AND HYPOTHESIS: We used a focus-group methodology to gather information about women's knowledge and attitudes regarding research participation. METHODS: Two in-person focus groups at seven clinical sites were conducted in women with pelvic floor disorder (PFD): one of women with clinical trial study experience and the other without such experience. One Web-based focus group combining both groups was also conducted. RESULTS: One hundred and five women (average age 58.6 years) participated. Participants in both groups believed that their physicians were the best source of information about clinical trials yet felt that other sources of trial information were important. Financial compensation was not a primary motivating factor for PFD trial enrollment but was, however, cited as an important consideration. Internet collection of data was feasible and provided information comparable with in-person focus groups. CONCLUSIONS: This study identified central themes guiding successful recruitment to and retention in PFD-related trials and provided insight regarding strategies that may guide future trials.

Cardinal and deep uterosacral ligament lines of action: MRI based 3D technique development and preliminary findings in normal women.

INTRODUCTION AND HYPOTHESIS: The cardinal ligament (CL) and deep uterosacral ligament (US) play a critical role in utero-vaginal support. This study aims to quantify their geometrical relationships in living women using a MRI-based 3D technique. METHODS: The angles between ligaments, the ligaments length and curvature were assessed on 3D models constructed from twenty MRIs of volunteers with normal support. How angle variation theoretically affects ligament tension was investigated using a simplified biomechanical model. RESULTS: The CLs are 18.1 ° ± 6.8 °(SD) from the cephalic-caudal body axis , and the USs are dorsally directed and 92.5 ° ± 13.5 from the body axis. The CLs are longer and more curved than US. The theoretical calculated tension on CL is 52 % larger than that on US. CONCLUSIONS: The CL is relatively parallel to the body axis while the US is dorsally directed. The tensions on these ligaments are affected by their orientations.

Self-reported natural history of recurrent prolapse among women presenting to a tertiary care center.

OBJECTIVE: To describe the characteristics of recurrent pelvic organ prolapse (POP). METHODS: A convenience sample of patients presenting with recurrent POP symptoms between October 2007 and February 2010 completed questionnaires. The survey focused on timing of recurrence(s), symptoms, and demographics. RESULTS: Ninety-seven women completed questionnaires. Thirty-four (35.1%) had undergone multiple prior treatments. Overall, 23 of 76 (30.3%) women had not informed their surgeon of the recurrence. Twenty-seven of 59 (45.8%) women reported that their symptoms were the same as before treatment, whereas 23 of 59 (39.0%) reported more severe symptoms. POP was considered to be persistent if symptoms returned within 3 months, and recurrent if symptom relief exceeded 3 months. After primary surgery, 28 of 79 (35.4%) cases were considered to be persistent, whereas 51 (64.6%) cases were recurrent. Similar percentages were seen after second and third treatments. CONCLUSION: Overall, 35% of participants experienced early return of symptoms. Almost one-third of participants had not informed their surgeon of the recurrence, indicating that there may not be an accurate self-assessment of outcome in the absence of careful follow-up.

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 midurethral slings (TMUS) 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 versus TMUS were examined. The IIQ and the ICIQ were obtained at baseline and at 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 postoperative, controlling for treatment group and baseline QoL. RESULTS: Improvement in IIQ was associated with the following: treatment success, younger age, improvement in stress urinary 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 reoperation (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.