Reanalysis of a randomized trial of 3 techniques of anterior colporrhaphy using clinically relevant definitions of success.

OBJECTIVE: The purpose of this study was to reanalyze the results of a previously published trial that compared 3 methods of anterior colporrhaphy according to the clinically relevant definitions of success. STUDY DESIGN: A secondary analysis of a trial of 114 subjects who underwent surgery for anterior pelvic organ prolapse who were assigned randomly to standard anterior colporrhaphy, ultralateral colporrhaphy, or anterior colporrhaphy plus polyglactin 910 mesh from 1996-1999. For the current analysis, success was defined as (1) no prolapse beyond the hymen, (2) the absence of prolapse symptoms (visual analog scale ≤ 2), and (3) the absence of retreatment. RESULTS: Eighty-eight percent of the women met our definition of success at 1 year. One subject (1%) underwent surgery for recurrence 29 months after surgery. No differences among the 3 groups were noted for any outcomes. CONCLUSION: Reanalysis of a trial of 3 methods of anterior colporrhaphy revealed considerably better success with the use of clinically relevant outcome criteria compared with strict anatomic criteria.

Obesity and outcomes after sacrocolpopexy.

OBJECTIVE: The purpose of this study was to compare outcomes after sacrocolpopexy (SC) between obese and healthy-weight women. STUDY DESIGN: Baseline and postoperative data were analyzed from the Colpopexy And Urinary Reduction Efforts (CARE) randomized trial of SC with or without Burch colposuspension in stress continent women with stages II-IV prolapse. Outcomes and complications were compared between obese and healthy-weight women. RESULTS: CARE participants included 74 obese (body mass index >/=30 kg/m(2)), 122 overweight (25-29.9 kg/m(2)), and 125 healthy-weight (18.5-24.9 kg/m(2)) women, and 1 underweight (< 18.5 kg/m(2)) woman. Compared to healthy-weight women, obese women were younger (59.0 +/- 9.9 vs 62.1 +/- 10.3 yrs; P = .04), more likely to have stage II prolapse (25.7% vs 11.2%; P = .01), and had longer operative times (189 +/- 52 vs 169 +/- 58 min; P = .02). Two years after surgery, stress incontinence, prolapse, symptom resolution, and satisfaction did not differ between the obese and healthy-weight groups. CONCLUSION: Most outcomes and complication rates after SC are similar in obese and healthy-weight women.

Reproducibility of dynamic MR imaging pelvic measurements: a multi-institutional study.

PURPOSE: To assess the reproducibility of bone and soft-tissue pelvimetry measurements obtained from dynamic magnetic resonance (MR) imaging studies in primiparous women across multiple centers. MATERIALS AND METHODS: All subjects prospectively gave consent for participation in this institutional review board-approved, HIPAA-compliant study. At six clinical sites, standardized dynamic pelvic 1.5-T multiplanar T2-weighted MR imaging was performed in three groups of primiparous women at 6-12 months after birth: Group 1, vaginal delivery with anal sphincter tear (n = 93); group 2, vaginal delivery without anal sphincter tear (n = 79); and group 3, cesarean delivery without labor (n = 26). After standardized central training, blinded readers at separate clinical sites and a blinded expert central reader measured nine bone and 10 soft-tissue pelvimetry parameters. Subsequently, three readers underwent additional standardized training, and reread 20 MR imaging studies. Measurement variability was assessed by using intraclass correlation for agreement between the clinical site and central readers. Acceptable agreement was defined as an intraclass correlation coefficient (ICC) of at least 0.7. RESULTS: There was acceptable agreement (ICC range, 0.71-0.93) for eight of 19 MR imaging parameters at initial readings of 198 subjects. The remaining parameters had an ICC range of 0.13-0.66. Additional training reduced measurement variability: Twelve of 19 parameters had acceptable agreement (ICC range, 0.70-0.92). Correlations were greater for bone (ICC, >or=0.70 in five [initial readings] and eight of nine [rereadings] variables) than for soft-tissue measurements (ICC, >or=0.70 in three [initial readings] of 10 and four [rereadings] of 10 readings, respectively). CONCLUSION: Despite standardized central training, there is high variability of pelvic MR imaging measurements among readers, particularly for soft-tissue structures. Although slightly improved with additional training, measurement variability adversely affects the utility of many MR imaging measurements for multicenter pelvic floor disorder research.

Enhancing participation of older women in surgical trials.

BACKGROUND: Older participants are often excluded from clinical trials, precluding a representative sample. STUDY DESIGN: Using qualitative and quantitative methods, we examined recruitment and retention of older women with pelvic organ prolapse in two surgical trials: the randomized Colpopexy And Urinary Reduction Efforts (CARE) study and the Longitudinal Pelvic Symptoms and Patient Satisfaction After Colpocleisis cohort study. Using focus groups, we developed a questionnaire addressing factors facilitating and impeding the recruitment and retention of older study participants and administered it to research staff. Enrollment-to-surgery ratios, missed visit rates, and dropout rates for older and younger participants were compared using Fisher's exact test, with cut-points of 70 and 80 years for the CARE and Colpocleisis studies, respectively. RESULTS: Questionnaires were completed by 23 physician investigators and 11 nurses or coordinators (92% response rate). Respondents indicated it was more difficult to recruit older research participants (32%), obtain informed consent (56%), and retain participants to study completion (50%). Challenges to recruitment included caregiver involvement in the decision to participate and participant comorbidities. Perceived barriers to retention were transportation, caregiver availability, and participant fatigue. Data quality was challenged by sensory and cognitive impairment, resulting in a change from telephone interviews to in-person visits in the Colpocleisis study. Older participants did not have higher dropout rates than younger participants. There were no differences in missed in-person visits or telephone interview rates between age groups. CONCLUSIONS: Strategies, albeit unstudied, could assist investigators in planning surgical trials that successfully enroll and retain older women.

Two-year outcomes after sacrocolpopexy with and without burch to prevent stress urinary incontinence.

OBJECTIVES: To report anatomic and functional outcomes 2 years after sacrocolpopexy in stress-continent women with or without prophylactic Burch colposuspension. METHODS: In the Colpopexy and Urinary Reduction Efforts (CARE) trial, stress-continent women undergoing sacrocolpopexy were randomized to receive or not receive a Burch colposuspension. Outcomes included urinary symptoms, other pelvic symptoms, and pelvic support. Standardized pelvic organ prolapse quantification examinations and validated outcome measures including the Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire were completed before surgery and at several postoperative intervals, including at 2 years. RESULTS: This analysis is based on 322 randomized participants; certain analyses were done with a subset based on data availability. Most were Caucasian (94%), with a mean age of 62±10 years (mean±standard deviation). Two years after surgery, 41.8% and 57.9% of women in the Burch and control groups, respectively, met the stress incontinence endpoint (presence of symptoms or positive cough stress test or interval treatment for stress incontinence, P=.020). The apex was well supported (point C within 2 cm of total vaginal length) in 95% of women, and this was not affected by concomitant Burch (P=.18). There was a trend toward fewer urgency symptoms in the Burch group (32.0% versus 44.5% no Burch, P=.085). Twenty participants experienced mesh or suture erosions. CONCLUSION: The early advantage of prophylactic Burch colposuspension for stress incontinence that was seen at 3 months remains at 2 years. Apical anatomic success rates are high and not affected by concomitant Burch. CLINICAL TRIAL REGISTRATION: (www.clinicaltrials.gov), ClinicalTrials.gov, NCT00065845. LEVEL OF EVIDENCE: I.

The correlation of voiding variables between non-instrumented uroflowmetery and pressure-flow studies in women with pelvic organ prolapse.

AIMS: To (1) correlate peak and maximum flow rates from non-instrumented flow (NIF) and pressure-flow studies (PFS) in women with pelvic organ prolapse (POP); (2) measure the impact of voided volume and degree of prolapse on correlations. METHODS: We compared four groups of women with stages II-IV POP. Groups 1 and 2 were symptomatically stress continent women participating in the colpopexy and urinary reduction efforts (CARE) trial; during prolapse reduction before sacrocolpopexy, Group 1 (n = 67) did not have and Group 2 (n = 84) had urodynamic stress incontinence (USI). Group 3 (n = 74) and Group 4 participants (n = 73), recruited specifically for this study, had stress urinary incontinence (SUI) symptoms. Group 3 planned sacrocolpopexy. Group 4 planned a different treatment option. Participants completed standardized uroflowmetry and pressure voiding studies. RESULTS: Subjects' median age was 61 years; median parity 3% and 80% had stage III or IV POP. Based on the Blaivas-Groutz nomogram, 49% of all women were obstructed. NIF and PFS peak and average flow rates had low correlations with one another (0.31, P < 0.001 and 0.35, P < 0.001, respectively). When NIF and PFS voided volumes were within 25% of each other, the peak and average flow rate correlations improved (0.52, P < 0.001 and 0.57, P < 0.001, respectively). As vaginal prolapse increased, correlations between NIF and PFS peak and average flow rates decreased. CONCLUSION: Peak and average flow rates are highly dependent on voided volume in women with prolapse. As the prolapse stage increases, correlations between NIF and PFS variables decrease.

Refractory idiopathic urge urinary incontinence and botulinum A injection.

PURPOSE: We compared 200 U intradetrusor botulinum toxin A vs placebo in women with refractory idiopathic urge incontinence. MATERIALS AND METHODS: This institutional review board approved, multicenter registered trial randomized women with refractory urge incontinence, detrusor overactivity incontinence and 6 or greater urge incontinence episodes in 3 days to botulinum toxin A or placebo at a 2:1 ratio. Refractory was defined as inadequate symptom control after 2 or more attempts at pharmacotherapy and 1 or more other first line therapies for detrusor overactivity incontinence. The primary outcome measure was time to failure, as evidenced by a Patient Global Impression of Improvement score of 4 or greater at least 2 months after injection, or changes in treatment (initiation or increase) at any time after injection. Safety data, including increased post-void residual volume, defined as more than 200 ml irrespective of symptoms, was obtained at specified time points. RESULTS: Approximately 60% of the women who received botulinum toxin A had a clinical response based on the Patient Global Impression of Improvement. The median duration of their responses was 373 days, significantly longer than the 62 days or less for placebo (p <0.0001). In the botulinum toxin A group increased post-void residual urine (12 of 28 women or 43%) and urinary tract infection in those with increased post-void residual urine (9 of 12 or 75%) exceeded expected ranges. Further injections were stopped after 43 patients were randomized, including 28 to botulinum toxin A and 15 to placebo. CONCLUSIONS: Local injection of 200 U botulinum toxin A was an effective and durable treatment for refractory overactive bladder. However, a transient post-void residual urine increase was experienced in 43% of patients. Botulinum toxin A for idiopathic overactive bladder is still under investigation.

The role of apical vaginal support in the appearance of anterior and posterior vaginal prolapse.

OBJECTIVE: To describe how simulated apical support affects the appearance of prolapse in the anterior and posterior vagina using a modification of the Pelvic Organ Prolapse Quantification (POP-Q) examination. METHODS: Women with prolapse stage II or greater were examined using the POP-Q. To simulate apical support, the posterior blade of a standard Graves speculum was positioned over the posterior vagina to support the vaginal apex while remeasuring points Aa and Ba and over the anterior vagina to support the apex while remeasuring points Ap and Bp. Change in anterior and posterior POP-Q points and prolapse stage with apical support were calculated. RESULTS: One hundred ninety-seven women were enrolled with mean age of 62+/-14 years, median parity of 2 (range 0-8), and mean body mass index of 28+/-5 kg/m(2). By standard POP-Q, 36% had stage II prolapse, 54% had stage III, and 10% had stage IV prolapse. With simulated apical support, point Ba changed to stage 0 or I in 55% of cases and point Bp changed to stage 0 or I in 30% (P<.001 for each point). Mean change for point Ba with apical support was 3.5+/-2.6 cm and point Bp was 1.9+/-2.9 cm (P<.001). CONCLUSION: When the POP-Q examination is performed with simulated apical support, the critical role of level I vaginal support on the position of the anterior and posterior vagina, particularly the anterior vagina, becomes apparent. LEVEL OF EVIDENCE: II.

The role of preoperative urodynamic testing in stress-continent women undergoing sacrocolpopexy: the Colpopexy and Urinary Reduction Efforts (CARE) randomized surgical trial.

The aim of this study is to describe results of reduction testing in stress-continent women undergoing sacrocolpopexy and to estimate whether stress leakage during urodynamic testing with prolapse reduction predicts postoperative stress incontinence. Three hundred twenty-two stress-continent women with stages II-IV prolapse underwent standardized urodynamics. Five prolapse reduction methods were tested: two at each site and both performed for each subject. Clinicians were masked to urodynamic results. At sacrocolpopexy, participants were randomized to Burch colposuspension or no Burch (control). P-values were computed by two-tailed Fisher's exact test or t-test. Preoperatively, only 12 of 313 (3.7%) subjects demonstrated urodynamic stress incontinence (USI) without prolapse reduction. More women leaked after the second method than after the first (22% vs. 16%; p = 0.012). Preoperative detection of USI with prolapse reduction at 300ml was pessary, 6% (5 of 88); manual, 16% (19 of 122); forceps, 21% (21 of 98); swab, 20% (32 of 158); and speculum, 30% (35 of 118). Women who demonstrated preoperative USI during prolapse reduction were more likely to report postoperative stress incontinence, regardless of concomitant colposuspension (controls 58% vs. 38% (p = 0.04) and Burch 32% vs. 21% (p = 0.19)). In stress-continent women undergoing sacrocolpopexy, few women demonstrated USI without prolapse reduction. Detection rates of USI with prolapse reduction varied significantly by reduction method. Preoperative USI leakage during reduction testing is associated with a higher risk for postoperative stress incontinence at 3 months. Future research is warranted in this patient population to evaluate other treatment options to refine predictions and further reduce the risk of postoperative stress incontinence.

Sexual function before and after sacrocolpopexy for pelvic organ prolapse.

OBJECTIVE: The objective of the study was to describe sexual function before and after sacrocolpopexy. STUDY DESIGN: In the Colpopexy and Urinary Reduction Efforts trial, sexual function was assessed in 224 women with sexual partners before and 1 year after surgery using validated questionnaires. RESULTS: After surgery, significantly fewer women reported sexual interference from "pelvic or vaginal symptoms" (32.5% 1 year after surgery vs 7.8% prior to surgery); fear of incontinence (10.7% vs 3.3%); vaginal bulging (47.3% vs 4.6%); or pain (39.9% vs 21.6%). The proportion of women with infrequent sexual desire (32%) did not change. More women were sexually active 1 year after surgery (171, 76.3%) than before surgery (148, 66.1%). The 11 women (7.4%) who became sexually inactive were more likely than sexually active women to report infrequent sexual desire (70.0% vs 22.1%, P < .001). The addition of Burch colposuspension did not have an impact on postoperative sexual function. CONCLUSION: After sacrocolpopexy, most women reported improvements in pelvic floor symptoms that previously interfered with sexual function. The addition of Burch colposuspension did not adversely influence sexual function.

The impact of fecal and urinary incontinence on quality of life 6 months after childbirth.

OBJECTIVE: The objective of the study was to investigate the impact of postpartum fecal incontinence (FI) and urinary incontinence (UI) on quality of life (QOL). STUDY DESIGN: Seven hundred fifty-nine primiparous women in the Childbirth and Pelvic Symptoms study were interviewed 6 months postpartum. FI and UI were assessed with validated questionnaires. We measured QOL with SF-12 summary scores, health utility index score (a measure of self-rated overall health), and the modified Manchester Health Questionnaire. RESULTS: Women with FI had worse self-rated health utility index scores (85.1 +/- 9.8 vs 88.0 +/- 11.6, P = .02) and Medical Outcomes Study Short Form Health Survey (SF-12) mental summary scores (46.8 +/- 9.2 vs 51.1 +/- 8.7, P < .0001) than women without FI or flatal incontinence. Women with UI had worse SF-12 mental summary scores (48.3 +/- 9.8 vs 51.6 +/- 7.8, P < .01) and self-rated health utility index scores (84.1 +/- 12.5 vs 88.7 +/- 10.1, P < .01) than women without UI. Women with both FI and UI had the lowest SF-12 mental summary scores (44.5 +/- 9.0). CONCLUSION: Six months after delivery, women experiencing FI or UI reported negative effects on health-related QOL. FI and UI together have a greater impact than either condition alone.

Bowel symptoms in women 1 year after sacrocolpopexy.

OBJECTIVE: The objective of the study was to evaluate changes in bowel symptoms after sacrocolpopexy. STUDY DESIGN: This was a prospectively planned, ancillary analysis of the Colpopexy and Urinary Reduction Efforts study, a randomized trial of sacrocolpopexy with or without Burch colposuspension in stress continent women with stages II-IV prolapse. In addition to sacrocolpopexy (+/- Burch), subjects underwent posterior vaginal or perineal procedures (PR) at each surgeon's discretion. The preoperative and 1 year postoperative Colorectal-anal Distress Inventory (CRADI) scores were compared within and between groups using Wilcoxon signed-rank and rank-sum tests, respectively. RESULTS: The sacrocolpopexy + PR group (n = 87) had more baseline obstructive colorectal symptoms (higher CRADI and CRADI-obstructive scores: P = .04 and < .01, respectively) than the sacrocolpopexy alone group (n = 211). CRADI total, obstructive, and pain/irritation scores significantly improved in both groups (all P < .01). Most bothersome symptoms resolved after surgery in both groups. CONCLUSION: Most bowel symptoms improve in women with moderate to severe pelvic organ prolapse after sacrocolpopexy.

Bladder symptoms 1 year after abdominal sacrocolpopexy with and without Burch colposuspension in women without preoperative stress incontinence symptoms.

OBJECTIVE: The objective of the study was to examine changes in bladder symptoms 1 year after abdominal sacrocolpopexy (ASC) with vs without Burch colposuspension. STUDY DESIGN: Women without stress urinary incontinence (SUI) symptoms undergoing ASC were randomized to receive or not receive Burch. One year later, irritative, obstructive, and SUI symptoms were assessed in 305 women using Urogenital Distress Inventory subscales. A composite "stress endpoint" combined SUI symptoms, positive stress test, and retreatment. RESULTS: In all women, the mean irritative score decreased from 19.6 +/- 16.3 (mean +/- SD) to 9.1 +/- 10.6; for obstructive symptoms, from 34.8 +/- 21.0 to 6.3 +/- 10.4 (both P < .001). Preoperative bothersome irritative symptoms resolved in 74.6% (126 of 169) and obstructive symptoms in 85.1% (212 of 249), independent of Burch. Fewer women with Burch had urge incontinence (14.5% vs 26.8%, P = .048) and fulfilled the stress endpoint (25.0% vs 40.1%, P = .012). CONCLUSION: ASC reduced bothersome irritative and obstructive symptoms. Prophylactic Burch reduced stress and urge incontinence.

Risk factors for sonographic internal anal sphincter gaps 6-12 months after delivery complicated by anal sphincter tear.

OBJECTIVE: The objective of the study was to identify risk factors for internal anal sphincter (IAS) gaps on postpartum endoanal ultrasound in women with obstetric anal sphincter tear. STUDY DESIGN: This prospective study included 106 women from the Childbirth and Pelvic Symptoms Imaging Supplementary Study who had third- or fourth-degree perineal laceration at delivery and endoanal ultrasound 6-12 months postpartum. Data were analyzed using Fisher's exact and t tests and logistic regression. RESULTS: Mean (+/- SD) age was 27.7 (+/- 6.2) years. Seventy-nine women (76%) were white and 22 (21%) black. Thirty-seven (35%) had sonographic IAS gaps. Risk factors for gaps included fourth- vs third-degree perineal laceration (odds ratio [OR] 15.4, 95% confidence interval [CI] 4.8, 50) and episiotomy (OR 3.3, 95% CI 1.2, 9.1). Black race (OR 0.23, 95% CI 0.05, 0.96) was protective. CONCLUSION: In women with obstetric anal sphincter repairs, fourth-degree tears and episiotomy are associated with more frequent sonographic IAS gaps.

Gastrointestinal complications following abdominal sacrocolpopexy for advanced pelvic organ prolapse.

OBJECTIVE: The aims of this secondary analysis of the "Colpopexy And Urinary Reduction Efforts" (CARE) study were to estimate the incidence of postoperative gastrointestinal complications and identify risk factors. STUDY DESIGN: We prospectively identified gastrointestinal complications and serious adverse events (SAE) for 12 months after sacrocolpopexy. Two surgeons independently reviewed reports of ileus or small bowel obstruction (SBO). RESULTS: Eighteen percent of 322 women (average age 61.3 years) reported "nausea, emesis, bloating, or ileus" during hospitalization and 9.8% at 6 weeks. Nineteen women (5.9%; CI 3.8%, 9.1%) had a possible ileus or SBO that generated SAE reports: 4 (1.2%, CI 0.5%,3.2%) were reoperated for SBO, 11 (3.4%, CI 1.9%,6.1%) were readmitted for medical management, and 4 had a prolonged initial hospitalization. Older age (P < .001) was a risk factor for ileus or SBO. CONCLUSION: One in 20 women experiences significant gastrointestinal morbidity after sacrocolpopexy. This information will aid preoperative counseling.

Lower urinary tract symptoms, quality of life and pelvic organ prolapse: irritative bladder and obstructive voiding symptoms in women planning to undergo abdominal sacrocolpopexy for advanced pelvic organ prolapse.

PURPOSE: We compared lower urinary tract and voiding symptoms in women with and without symptoms of stress urinary incontinence who were planning to undergo abdominal sacrocolpopexy for pelvic organ prolapse. MATERIALS AND METHODS: Subjects without stress urinary incontinence included 293 women in the Colpopexy and Urinary Reduction Efforts Trial. Subjects with stress urinary incontinence included 82 women who met trial inclusion criteria except for having stress urinary incontinence symptoms. We assessed symptoms and quality of life using validated measures. RESULTS: After adjusting for age, race and site subjects with stress urinary incontinence had higher irritative and obstructive symptom subscale scores and reported greater symptom bother, greater impact of colorectal and prolapse symptoms, and poorer physical and mental health. CONCLUSIONS: Women with prolapse and stress urinary incontinence had more lower urinary tract symptoms and reported more functional impact. This is contrary to our hypothesis that women with prolapse and stress urinary incontinence would have fewer irritative, obstructive and voiding symptoms because of the relief valve effect of the less resistant urethra.