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.
(Abstracted from Obstet Gynecol 2018;131:475–483) The incidence of posthysterectomy prolapse ranges from 6% to 8%. Many surgeons treat posthysterectomy or vault prolapse differently than uterovaginal prolapse in women planning to undergo surgery for apical pelvic organ prolapse (POP), because they believe that a previous hysterectomy increases both risk of prolapse recurrence and adverse events.
OBJECTIVETo 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.METHODSWomen 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.RESULTSFour 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.CONCLUSIONSurgical success of stage II-IV vault prolapse and uterovaginal prolapse apical repair was similar whether performed vaginally or abdominally at 1-2 years postoperatively.
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.
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 1year after the first vaginal delivery are affected by biologically plausible factors that may impact muscle, nerve and connective tissue healing during recovery (first 8weeks 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 1year 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.
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.
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/m2) 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 &kgr; 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.
ObjectivesQuality data comparing outcomes of open ASC to VAR for apical repair of stage 2-4 prolapse are rare. In preparation for potential future clinical trials, we retrospectively analyzed existing randomized trial data.Materials and MethodsParticipants were in one of three United States multicenter randomized trials. Women were not randomized to ASC versus VAR in any trial. VAR included uterosacral, sacrospinous, and illiococcygeal suspensions; all ASCs were open. Transvaginal mesh procedures were excluded. Success was defined as no bothersome bulge symptoms as measured by the PFDI, no prolapse beyond the hymen on POPQ and no prolapse retreatment up to 24 months. POPQ exams, POPDI and POPIQ questionnaires were administered at baseline and follow-up visits. By design, one VAR trial did not have 24 month follow-up. SAEs related to surgeries were collected at multiple time-points. Success and QOL outcomes were analyzed using longitudinal mixed effects models to obtain valid outcome estimates at specific visit times, accounting for data missing at random due to the varied planned visits. Comparisons between groups controlled for site, age, BMI, initial POPQ stage, baseline QOL scores, prior prolapse repair and concurrent anterior or posterior repair.ResultsOne thousand twenty-two of 1159 women who underwent surgery in the 3 trials met inclusion criteria; 701 underwent VAR and 321 ASC repair. The ASC group was older, more likely White, to have had prior UI or POP repair, and to have POPQ Stage 4 prolapse (all P<0.05). Anterior repair was performed in 63% of the VAR group; 18% of the ASC group underwent abdominal paravaginal repair. Likewise, the VAR group was more likely to undergo posterior repair (49 vs 28%, p < 0.001). While POPQ measurements, bulge symptoms and support at or above the hymen improved significantly in both groups, overall comparative treatment success was higher at every time point in the ASC group (overall OR = 7.2, 95% CI = 4.2-12.4), however, retreatment in both groups was low (1% ASC vs 5% VAR at 24 months). POPDI and POPIQ scores significantly improved in both groups, and were not different through 12 months (all p > 0.18). At 24 months POPDI (estimated difference in reduction 9.97, 95% CI = 0.73-19.21) and POPQI scores (estimated difference in reduction 17.4, 95% CI = 8.1-26.7) reflected greater improvement in the ASC group. Through 6 weeks following surgery, SAEs were not different between groups (15% vs 10%, ASC vs VAR, OR = 1.1, 95% CI = 0.5-2.2). Through one year postoperatively, SAEs were twice as common in the ASC group (33%, vs 15%, ASC vs VAR, OR = 2.1, 95% CI = 1.2-3.6).ConclusionIn this analysis of pre-existing data from three randomized trials, open ASC was more likely to result in successful treatment of prolapse but also more likely to be associated with an SAE in the year following surgery. For both groups, retreatment rates were low and although statistically significant, changes in quality of life at 24 months between groups may not be clinically significant. Future randomized trials should address longer term success and SAE rates as well as the impact of minimally invasive approaches on these comparative outcomes.DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS:Rebecca G. Rogers: American Medical Systems, DSMB Chair for TRANSFORM trial, Honorarium; UPtoDate, Author on Prolapse section, Royalties; McGraw Hill, Editor for textbook, RoyaltiesTracy Nolen: Nothing to discloseAlison Weidner: Merck and Glaxo Smith Kline, Consultant, Consultancy fees; GenProbe, Investigator, Grant supportHolly E. Richter: Pelvalon, Research Grant and Consultant, Research Grant, Consultancy Fees; Kimberly Clark, Consultant, Consultancy Fees; UpToDate, Author, Royalties; Society of Gynecologic Surgeons, Board member, Meeting supportJ Eric Jelovsek: Nothing to discloseSusan Meikle: Nothing to discloseJon Shepherd: Nothing to discloseHeidi S. Harvie: Nothing to discloseLinda Brubaker: UptoDate, Editor, Editorial RevenueShawn Menefee: Nothing to discloseDeborah Myers: Nothing to discloseYvonne Hsu: Nothing to discloseJoseph I. Schaffer: Nothing to discloseDennis Wallace: Nothing to disclose ObjectivesQuality data comparing outcomes of open ASC to VAR for apical repair of stage 2-4 prolapse are rare. In preparation for potential future clinical trials, we retrospectively analyzed existing randomized trial data. Quality data comparing outcomes of open ASC to VAR for apical repair of stage 2-4 prolapse are rare. In preparation for potential future clinical trials, we retrospectively analyzed existing randomized trial data. Materials and MethodsParticipants were in one of three United States multicenter randomized trials. Women were not randomized to ASC versus VAR in any trial. VAR included uterosacral, sacrospinous, and illiococcygeal suspensions; all ASCs were open. Transvaginal mesh procedures were excluded. Success was defined as no bothersome bulge symptoms as measured by the PFDI, no prolapse beyond the hymen on POPQ and no prolapse retreatment up to 24 months. POPQ exams, POPDI and POPIQ questionnaires were administered at baseline and follow-up visits. By design, one VAR trial did not have 24 month follow-up. SAEs related to surgeries were collected at multiple time-points. Success and QOL outcomes were analyzed using longitudinal mixed effects models to obtain valid outcome estimates at specific visit times, accounting for data missing at random due to the varied planned visits. Comparisons between groups controlled for site, age, BMI, initial POPQ stage, baseline QOL scores, prior prolapse repair and concurrent anterior or posterior repair. Participants were in one of three United States multicenter randomized trials. Women were not randomized to ASC versus VAR in any trial. VAR included uterosacral, sacrospinous, and illiococcygeal suspensions; all ASCs were open. Transvaginal mesh procedures were excluded. Success was defined as no bothersome bulge symptoms as measured by the PFDI, no prolapse beyond the hymen on POPQ and no prolapse retreatment up to 24 months. POPQ exams, POPDI and POPIQ questionnaires were administered at baseline and follow-up visits. By design, one VAR trial did not have 24 month follow-up. SAEs related to surgeries were collected at multiple time-points. Success and QOL outcomes were analyzed using longitudinal mixed effects models to obtain valid outcome estimates at specific visit times, accounting for data missing at random due to the varied planned visits. Comparisons between groups controlled for site, age, BMI, initial POPQ stage, baseline QOL scores, prior prolapse repair and concurrent anterior or posterior repair. ResultsOne thousand twenty-two of 1159 women who underwent surgery in the 3 trials met inclusion criteria; 701 underwent VAR and 321 ASC repair. The ASC group was older, more likely White, to have had prior UI or POP repair, and to have POPQ Stage 4 prolapse (all P<0.05). Anterior repair was performed in 63% of the VAR group; 18% of the ASC group underwent abdominal paravaginal repair. Likewise, the VAR group was more likely to undergo posterior repair (49 vs 28%, p < 0.001). While POPQ measurements, bulge symptoms and support at or above the hymen improved significantly in both groups, overall comparative treatment success was higher at every time point in the ASC group (overall OR = 7.2, 95% CI = 4.2-12.4), however, retreatment in both groups was low (1% ASC vs 5% VAR at 24 months). POPDI and POPIQ scores significantly improved in both groups, and were not different through 12 months (all p > 0.18). At 24 months POPDI (estimated difference in reduction 9.97, 95% CI = 0.73-19.21) and POPQI scores (estimated difference in reduction 17.4, 95% CI = 8.1-26.7) reflected greater improvement in the ASC group. Through 6 weeks following surgery, SAEs were not different between groups (15% vs 10%, ASC vs VAR, OR = 1.1, 95% CI = 0.5-2.2). Through one year postoperatively, SAEs were twice as common in the ASC group (33%, vs 15%, ASC vs VAR, OR = 2.1, 95% CI = 1.2-3.6). One thousand twenty-two of 1159 women who underwent surgery in the 3 trials met inclusion criteria; 701 underwent VAR and 321 ASC repair. The ASC group was older, more likely White, to have had prior UI or POP repair, and to have POPQ Stage 4 prolapse (all P<0.05). Anterior repair was performed in 63% of the VAR group; 18% of the ASC group underwent abdominal paravaginal repair. Likewise, the VAR group was more likely to undergo posterior repair (49 vs 28%, p < 0.001). While POPQ measurements, bulge symptoms and support at or above the hymen improved significantly in both groups, overall comparative treatment success was higher at every time point in the ASC group (overall OR = 7.2, 95% CI = 4.2-12.4), however, retreatment in both groups was low (1% ASC vs 5% VAR at 24 months). POPDI and POPIQ scores significantly improved in both groups, and were not different through 12 months (all p > 0.18). At 24 months POPDI (estimated difference in reduction 9.97, 95% CI = 0.73-19.21) and POPQI scores (estimated difference in reduction 17.4, 95% CI = 8.1-26.7) reflected greater improvement in the ASC group. Through 6 weeks following surgery, SAEs were not different between groups (15% vs 10%, ASC vs VAR, OR = 1.1, 95% CI = 0.5-2.2). Through one year postoperatively, SAEs were twice as common in the ASC group (33%, vs 15%, ASC vs VAR, OR = 2.1, 95% CI = 1.2-3.6). ConclusionIn this analysis of pre-existing data from three randomized trials, open ASC was more likely to result in successful treatment of prolapse but also more likely to be associated with an SAE in the year following surgery. For both groups, retreatment rates were low and although statistically significant, changes in quality of life at 24 months between groups may not be clinically significant. Future randomized trials should address longer term success and SAE rates as well as the impact of minimally invasive approaches on these comparative outcomes.DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS:Rebecca G. Rogers: American Medical Systems, DSMB Chair for TRANSFORM trial, Honorarium; UPtoDate, Author on Prolapse section, Royalties; McGraw Hill, Editor for textbook, RoyaltiesTracy Nolen: Nothing to discloseAlison Weidner: Merck and Glaxo Smith Kline, Consultant, Consultancy fees; GenProbe, Investigator, Grant supportHolly E. Richter: Pelvalon, Research Grant and Consultant, Research Grant, Consultancy Fees; Kimberly Clark, Consultant, Consultancy Fees; UpToDate, Author, Royalties; Society of Gynecologic Surgeons, Board member, Meeting supportJ Eric Jelovsek: Nothing to discloseSusan Meikle: Nothing to discloseJon Shepherd: Nothing to discloseHeidi S. Harvie: Nothing to discloseLinda Brubaker: UptoDate, Editor, Editorial RevenueShawn Menefee: Nothing to discloseDeborah Myers: Nothing to discloseYvonne Hsu: Nothing to discloseJoseph I. Schaffer: Nothing to discloseDennis Wallace: Nothing to disclose In this analysis of pre-existing data from three randomized trials, open ASC was more likely to result in successful treatment of prolapse but also more likely to be associated with an SAE in the year following surgery. For both groups, retreatment rates were low and although statistically significant, changes in quality of life at 24 months between groups may not be clinically significant. Future randomized trials should address longer term success and SAE rates as well as the impact of minimally invasive approaches on these comparative outcomes.
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.
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.
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.
The objective of the study was to determine the relationship between midsagittal vaginal wall geometric parameters and the degree of anterior vaginal prolapse. We have previously presented data indicating that about half of anterior wall descent can be explained by the degree of apical descent present (Summers et al., Am J Obstet Gynecol, 194:1438–1443, 2006). This led us to examine whether other midsagittal vaginal geometric parameters are associated with anterior wall descent. Magnetic resonance (MR) scans of 145 women from the prior study were suitable for analysis after eight were excluded because of inadequate visibility of the anterior vaginal wall. Subjects had been selected from a study of pelvic organ prolapse that included women with and without prolapse. All patients underwent supine dynamic MR scans in the midsagittal plane. Anterior vaginal wall length, location of distal vaginal wall point, and the area under the midsagittal profile of the anterior vaginal wall were measured during maximal Valsalva. A linear regression model was used to examine how much of the variance in cystocele size could be explained by these vaginal parameters. When both apical descent and vaginal length were considered in the linear regression model, 77% ( R 2 = 0.77, p < 0.001) of the variation in anterior wall descent was explained. Distal vaginal point and a measure anterior wall shape, the area under the profile of the anterior vaginal wall, added little to the model. Increasing vaginal length was positively correlated with greater degrees of anterior vaginal prolapse during maximal Valsalva ( R 2 = 0.30, p < 0.01) determining 30% of the variation in anterior wall decent. Greater degrees of anterior vaginal prolapse are associated with a longer vaginal wall. Linear regression modeling suggests that 77% of anterior wall descent can be explained by apical descent and midsagittal anterior vaginal wall length.
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.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.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) cmH(2)O 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) cmH(2)O, respectively] than the carry-in-backpack activity [55.5 (11.4) cmH(2)O; p < 0.0001].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.
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.
In Brief 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. Qualitative interviews reveal long-lasting negative physical and emotional effects after optimized treatment in a tertiary care center for vaginal mesh complications.
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.
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.
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.
BackgroundFirst-line conservative treatment for stress urinary incontinence (SUI) in women is behavioral intervention, including pelvic-floor muscle (PFM) exercise and bladder control strategies.ObjectiveThe 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.DesignThis 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).MethodsData 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.ResultsDuring 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.LimitationsAdherence and barrier questionnaires were not validated.ConclusionsAdherence 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.