Success and failure are dynamic, recurrent event states after surgical treatment for pelvic organ prolapse.

BACKGROUND: The ideal measure of success after surgery for pelvic organ prolapse has long been debated. Historically, strict definitions based on anatomic perfection have dominated the literature. However, the importance of patient-centered perception of outcomes is equally or more important when comparing the success of various prolapse surgeries. Understanding the limitations of existing outcome definitions will guide surgical outcome reporting and comparisons of pelvic organ prolapse surgeries. OBJECTIVE: This study aimed to describe the relationships and overlap among the participants who met the anatomic, subjective, and retreatment definitions of success or failure after pelvic organ prolapse surgery; demonstrate rates of transition between success and failure over time; and compare scores from the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years among these definitions. STUDY DESIGN: Definitions of surgical success were evaluated at 3 or 6, 12, 24, 36, 48, and 60 months after surgery for ≥stage II pelvic organ prolapse in a cohort of women (N=1250) from 4 randomized clinical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical failure was defined by a composite measure requiring 1 or more of (1) anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of >0), (2) subjective failure (presence of bothersome vaginal bulge symptoms), or (3) pessary or surgical retreatment for pelvic organ prolapse. Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years were compared among participants who met a variety of definitions of success and failure including novel "intermittent" success and failure over time. RESULTS: Among the 433 of 1250 women (34.6%) who had surgical failure outcomes at ≥1 time point, 85.5% (370 of 433) met only 1 component of the composite outcome at the assessment of initial failure (anatomic failure, 46.7% [202 of 433]; subjective failure, 36.7% [159 of 433]; retreatment, 2.1% [9 of 433]). Only 12.9% (56 of 433) met the criteria for both for anatomic and subjective failure. Despite meeting the criteria for failure in primary study reporting, 24.2% of these (105 of 433) transitioned between success and failure during follow-up, of whom 83.8% (88 of 105) met the criteria for success at their last follow-up. There were associations between success or failure classification and the 1- and 2-year quality-adjusted life years and a time-varying group effect on Pelvic Organ Prolapse Distress Inventory and Short-Form Six-Dimension health index scores. CONCLUSION: True failure rates after prolapse surgery may be overestimated in the current literature. Only 13% of clinical trial subjects initially met both subjective and objective criteria for failure. Approximately one-quarter of failures were intermittent and transitioned between success and failure over time, with most intermittent failures being in a state of "surgical success" at their last follow-up. Current composite definitions of success or failure may result in the overestimation of surgical failure rates, potentially explaining, in part, the discordance with low retreatment rates after pelvic organ prolapse surgery.

A randomized trial of urodynamic testing before stress-incontinence surgery.

BACKGROUND: Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes. METHODS: We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of "much better" or "very much better" on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points. RESULTS: A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, -0.3 percentage points; 95% confidence interval, -7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes. CONCLUSIONS: For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.).

Pelvic organ prolapse in a cohort of women treated for stress urinary incontinence.

OBJECTIVE: The aim of our study was to observe pelvic organ prolapse (POP) over time, treated and untreated, in a group of highly characterized women being followed up subjectively and objectively over 5-7 years following continence surgery. STUDY DESIGN: We measured baseline prolapse symptoms and anatomic prolapse in subjects enrolled in the trial of midurethral sling (TOMUS) and E-TOMUS, and measured these same parameters annually for 5-7 years after the index surgery. Additional information about subsequent treatment for POP was also recorded. RESULTS: In all, 597 women were randomized to 1 of 2 midurethral sling procedures in the TOMUS; concomitant vaginal procedures for POP were allowed at the surgeon's discretion. Stage 2 POP was present at baseline in 291 subjects (49%). Symptoms of POP were reported in 67 (25%). Of the asymptomatic women, 34 of 223 (15%) underwent a concomitant POP repair at the time of index sling surgery. Anatomic progression of prolapse in women with asymptomatic, unoperated stage 2 POP over the next 72 months was infrequent and occurred in only 3 of 189 subjects (2%); none underwent surgery for POP. Most symptomatic women (47/67 [70%]) underwent a concomitant repair for POP at the index sling surgery. Three of the 47 women who had undergone concomitant repair for symptomatic stage 2 POP underwent repeat POP surgery (2 at 36 months and 1 at 48 months.) CONCLUSION: For patient populations similar to the TOMUS and E-TOMUS populations, surgeons may counsel women with asymptomatic stage 2 POP that their prolapse is unlikely to require surgery in the next 5-7 years.

Retropubic versus transobturator midurethral slings for stress incontinence.

BACKGROUND: Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. METHODS: We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. RESULTS: A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. CONCLUSIONS: The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)

The pelvic floor complication scale: a new instrument for reconstructive pelvic surgery.

OBJECTIVE: The purpose of this study was to develop and test a unique, new pelvic floor surgery complication scale and compare it with an existing validated measure. STUDY DESIGN: Surgeons from 2 clinical trials networks rated complications based on perceived patient bother, severity, and duration of disability to develop a pelvic floor complication scale (PFCS). PFCS scores were calculated for subjects in 2 multicenter pelvic floor surgical trials. The PFCS and modified Clavien-Dindo scores were evaluated for associations with length of hospitalization, satisfaction, and quality-of-life measures (health utilities index, short form-36, urogenital distress inventory, and incontinence impact questionnaire). RESULTS: We calculated PFCS scores for 977 subjects. Higher PFCS and Clavien-Dindo scores similarly were associated with longer length of hospitalization (P < .01), lower satisfaction (P < .01), lower Health Utilities Index scores (P = .02), lower short form-36 scores (P = .02), higher urogenital distress Inventory scores (P < .01), and incontinence impact questionnaire scores (P < .01) at 3 months. No associations were present at 1 year. CONCLUSION: The PFCS compares favorably to the validated modified Clavien-Dindo instrument.

Transvaginal Mesh Compared With Native Tissue Repair for Pelvic Organ Prolapse.

OBJECTIVE: To compare the safety and effectiveness of transvaginal mesh repair and native tissue repair, in response to a U.S. Food and Drug Administration (FDA) 522 study order to assess co-primary endpoints of superiority and noninferiority. METHODS: This was a prospective, nonrandomized, parallel cohort, multi-center trial comparing transvaginal mesh with native tissue repair for the treatment of pelvic organ prolapse. The primary endpoints were composite treatment success at 36 months comprised of anatomical success (defined as pelvic organ prolapse quantification [POP-Q] point Ba≤0 and/or C≤0), subjective success (vaginal bulging per the PFDI-20 [Pelvic Floor Distress Inventory]), and retreatment measures, as well as rates of serious device-related or serious procedure-related adverse events. Secondary endpoints included a composite outcome similar to the primary composite outcome but with anatomical success defined as POP-Q point Ba<0 and/or C<0, quality-of-life measures, mesh exposure and mesh- and procedure-related complications. Propensity score stratification was applied. RESULTS: Primary endpoint composite success at 36 months was 89.3% (201/225) for transvaginal mesh and 80.2% (389/485) for native tissue repair, demonstrating noninferiority at the preset margin of 12% (propensity score-adjusted treatment difference 6.5%, 90% CI -0.2% to 13.2%). Using the primary composite endpoint, transvaginal mesh was not superior to native tissue repair (P=.056). Using the secondary composite endpoint, superiority of transvaginal mesh over native tissue repair was noted (P=.009), with a propensity score-adjusted difference of 10.6% (90% CI 3.3-17.9%) in favor of transvaginal mesh. Subjective success for both the primary and secondary endpoint was 92.4% for transvaginal mesh, 92.8% for native tissue repair, a propensity score-adjusted difference of -4.3% (CI -12.3% to 3.8%). For the primary safety endpoint, 3.1% (7/225) of patients in the transvaginal mesh (TVM) group and 2.7% (13/485) of patients in the native tissue repair (NTR) group developed serious adverse events, demonstrating that transvaginal mesh was noninferior to native tissue repair (-0.4%, 90% CI -2.7% to 1.9%). Overall device-related and/or procedure-related adverse event rates were 35.1% (79/225) in the TVM group and 46.4% (225/485) in the NTR group (-15.7%, 95% CI -24.0% to -7.5%). CONCLUSION: Transvaginal mesh repair for the treatment of anterior and/or apical vaginal prolapse was not superior to native tissue repair at 36 months. Subjective success, an important consideration from the patient-experience perspective, was high and not statistically different between groups. Transvaginal mesh repair was as safe as native tissue repair with respect to serious device-related and/or serious procedure-related adverse events. FUNDING SOURCE: This study was sponsored by Boston Scientific and developed in collaboration with FDA personnel from the Office of Surveillance and Biometrics, Division of Epidemiology. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01917968.

Burch colposuspension versus fascial sling to reduce urinary stress incontinence.

BACKGROUND: Many surgical procedures are available for women with urinary stress incontinence, yet few randomized clinical trials have been conducted to provide a basis for treatment recommendations. METHODS: We performed a multicenter, randomized clinical trial comparing two procedures--the pubovaginal sling, using autologous rectus fascia, and the Burch colposuspension--among women with stress incontinence. Women were eligible for the study if they had predominant symptoms associated with the condition, a positive stress test, and urethral hypermobility. The primary outcomes were success in terms of overall urinary-incontinence measures, which required a negative pad test, no urinary incontinence (as recorded in a 3-day diary), a negative cough and Valsalva stress test, no self-reported symptoms, and no retreatment for the condition, and success in terms of measures of stress incontinence specifically, which required only the latter three criteria. We also assessed postoperative urge incontinence, voiding dysfunction, and adverse events. RESULTS: A total of 655 women were randomly assigned to study groups: 326 to undergo the sling procedure and 329 to undergo the Burch procedure; 520 women (79%) completed the outcome assessment. At 24 months, success rates were higher for women who underwent the sling procedure than for those who underwent the Burch procedure, for both the overall category of success (47% vs. 38%, P=0.01) and the category specific to stress incontinence (66% vs. 49%, P<0.001). However, more women who underwent the sling procedure had urinary tract infections, difficulty voiding, and postoperative urge incontinence. CONCLUSIONS: The autologous fascial sling results in a higher rate of successful treatment of stress incontinence but also greater morbidity than the Burch colposuspension. (ClinicalTrials.gov number, NCT00064662 [ClinicalTrials.gov] .).

Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse.

OBJECTIVE: To describe sexual activity and risks for dyspareunia after pelvic organ prolapse surgery. METHODS: This was a secondary analysis of data from four randomized trials conducted between 2002 and 2018. Standard assessments and validated measures of sexual function were assessed at baseline and at 12 months postoperatively. Anterior apical surgeries were grouped by approach: transvaginal native tissue repairs, transvaginal mesh or graft-augmented repairs, and abdominal sacrocolpopexy. Additional surgeries, which included posterior repair, hysterectomy, and slings, were analyzed. Bivariate analyses and logistic regression models identified risk factors for postoperative dyspareunia. RESULTS: Of the 1,337 women enrolled in the trials, 932 had sufficient outcome data to determine dyspareunia status. Of these before surgery, 445 (47.8%) were sexually active without dyspareunia, 89 (9.6%) were sexually active with dyspareunia, 93 (10.0%) were not sexually active owing to fear of dyspareunia, and 305 (32.7%) were not sexually active for other reasons. At 12 months, dyspareunia or fear of dyspareunia was present in 63 of 627 (10.0%); occurred de novo in 17 of 445 (3.8%) and resolved in 136 of 182 (74.7%). Multivariable regression demonstrated baseline dyspareunia as the only factor associated with postoperative dyspareunia (adjusted odds ratio 7.8, 95% CI 4.2-14.4). No other factors, including surgical approach, were significantly associated with postoperative dyspareunia. Too few had de novo dyspareunia to perform modeling. CONCLUSION: Dyspareunia is common in one in five women before undergoing prolapse surgery. Surgical repair resolves dyspareunia in three out of four women with low rates of de novo dyspareunia at less than 4%. Preoperative dyspareunia appears to be the only predictor of postoperative dyspareunia. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT00065845, NCT00460434, NCT00597935, and NCT01802281.

Predictors of success with postoperative voiding trials after a mid urethral sling procedure.

PURPOSE: We identified predictors of passing a voiding trial after incontinence surgery with a mid urethral sling and examined if successful performance on a voiding trial was maintained. MATERIALS AND METHODS: A total of 89 women scheduled for incontinence surgery were enrolled from July 2005 until April 2006. Voiding trials were performed the day of discharge from the hospital, with a two-thirds volume void after a 300 ml fill considered passing. Those who passed underwent a second voiding trial 3 hours later. RESULTS: Of the participants 60 (67.4%) underwent tension-free vaginal tape surgery, 29 underwent transobturator tape (32.6%) and 64 (71.9%) underwent concurrent vaginal repairs. A total of 59 (67.0%) participants passed the first voiding trial. Univariate analysis identified 12 potential predicting variables for passing the first voiding trial. From these 12, model building via backward stepwise logistic regression found maximum flow on preoperative uroflowmetry to be the only significant predictive variable (p = 0.0002). Of the 59 women who passed the initial voiding trial 9 (16.4%) failed the second voiding trial. None of the 11 participants who had maximal flow rates greater than 30 cc per second failed the first or second voiding trial, whereas 17 of 22 subjects (77.3%) who had maximal flow rates less than 15 cc per second failed either of these trials. CONCLUSIONS: Maximum flow rates on preoperative uroflowmetry were the best predictor of passing an initial voiding trial after undergoing a mid urethral sling procedure for incontinence. However, the ability to maintain performance on a second voiding trial, even only 3 hours after passing an initial trial, is not assured.

Intraabdominal pressure changes associated with lifting: implications for postoperative activity restrictions.

OBJECTIVE: The purpose of this study was to describe the effect of the lifting maneuver and the quantity of weight lifted on the generation of intraabdominal pressure. STUDY DESIGN: Forty-one women who underwent urodynamic evaluation performed 4 lifting maneuvers, each while lifting 0, 2.5, 5, 10, and 15 kg. The lifting maneuvers were routine activities that included squatting with and without assistance, lifting from a counter, and receiving weight. Pressure was recorded with a rectal microtip catheter. Each lift was performed twice, and the average pressure change was analyzed. RESULTS: When controlled for potential confounding variables, repeated-measures analysis of variance revealed a significant interaction between lift weight and lift maneuver (P < .001). Squatting was associated with generation of higher intraabdominal pressure than lifting from a counter or receiving weights into outstretched arms (P < .001). Lifting > or = 2.5 kg resulted in significant changes in intraabdominal pressure, regardless of lift maneuver (P < .001). CONCLUSION: Both the lifting maneuver and the quantity of weight should be considered when counseling patients regarding postoperative lifting.

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.

Outcomes with porcine graft placement in the anterior vaginal compartment in patients who undergo high vaginal uterosacral suspension and cystocele repair.

OBJECTIVE: The purpose of this study was to prospectively assess the cases of patients who had undergone a high uterosacral suspension and anterior repair with anterior compartment placement of porcine dermis graft. STUDY DESIGN: Thirty-six patients who underwent transvaginal high uterosacral suspension and cystocele repair with graft augmentation from June 2001 to July 2004 were identified from the University of Alabama at Birmingham Genitourinary Disorders database. Analysis included the pre- and postoperative Pelvic Organ Prolapse Quantification examinations and incontinence impact questionnaire-7/urogenital distress inventory-6. RESULTS: Mean Pelvic Organ Prolapse Quantification Ba improved from +3.3 +/- 2.2 cm to -0.6 +/- 1.7 cm (P < .01). Postoperative Ba was prolapse stage II or greater in 50% of subjects. Mean incontinence impact questionnaire-7 scores improved from 36.2 +/- 31.9 to 15.6 +/- 26.2 (P < .01), as did mean urogenital distress inventory-6 scores from 58.2 +/- 26.8 to 23.8 +/- 22.6 (P < .01). CONCLUSION: Significant improvements in Pelvic Organ Prolapse Quantification measures, urinary symptoms, and the impact of incontinence were seen after the operation. However, a significant proportion of patients had Pelvic Organ Prolapse Quantification stage II prolapse or greater, which made it unclear whether graft use confers a significant advantage.

Randomized trial of medical treatment versus hysterectomy for abnormal uterine bleeding: resource use in the Medicine or Surgery (Ms) trial.

OBJECTIVE: This study was undertaken to compare resource use outcomes for participants in the Medicine or Surgery (Ms) randomized trial. STUDY DESIGN: In a randomized controlled trial, we compared resources used during a 24-month follow-up period by women with abnormal uterine bleeding who were randomly assigned to either expanded medical treatment or hysterectomy. RESULTS: Women randomly assigned to hysterectomy used significantly more resources (medicine = $4479, hysterectomy = $6777; P = .03), with almost all the difference caused by the hysterectomy procedure. Fifty-three percent of women randomly assigned to medicine had a hysterectomy during the follow-up period; women who were able to continue on medical therapy had mean total resource use of $2595 compared with $6128 for medicine patients who eventually had surgery. CONCLUSION: For women with abnormal uterine bleeding refractory to cyclic medroxyprogesterone acetate, compared with expanded medical treatment, hysterectomy increases resource use significantly and results in better clinical and 6-month quality-of-life outcomes.

Urinary and anal incontinence in morbidly obese women considering weight loss surgery.

OBJECTIVE: To estimate prevalence and correlates of urinary and anal incontinence in morbidly obese women undergoing evaluation for laparoscopic weight loss surgery. METHODS: From October 2003 to February 2005, 180 women with body mass index (BMI) of 40 or greater underwent evaluation for laparoscopic weight loss surgery. Using an established Web site, questionnaires were completed to assess symptoms of urinary incontinence, including the Medical, Epidemiological, and Social Aspects of Aging Questionnaire (MESA). Anal incontinence was assessed by asking, "Do you have any uncontrolled anal leakage?" A number of clinical and demographic variables were examined as potential risk factors for urinary incontinence and anal incontinence. RESULTS: Mean age was 39.8 years (range 16-55). Body mass index ranged from 40 to 81 (mean 49.5). Prevalence of urinary incontinence was 66.9% and anal incontinence was 32.0% (45.6% loss of gas only, 21.1% liquid stool only, 24.6% gas and liquid stool only, 8.8% solid stool). In simple logistic regression, presence of urinary incontinence was associated with age (odds ratio [OR] 1.05, 95% confidence interval [CI] 1.01-1.09), number of children (OR 1.54, 95% CI 1.15-2.07), anal incontinence (OR 6.34, 95% CI 2.52-15.93), arthritis (OR 6.04, 95% CI 1.76-20.78), and sleep apnea (OR 2.30, 95% CI 1.21-4.37). Multivariable logistic regression identified 3 factors independently associated with urinary incontinence: number of children (OR 1.55, 95% CI 1.12-2.12), arthritis (OR 5.46, 95% CI 1.51-19.73), and anal incontinence (OR 6.27, 95% CI 2.42-16.26). Presence of anal incontinence was associated only with the presence of urinary incontinence (OR 6.34, 95% CI 2.52-15.93). CONCLUSION: Prevalence of urinary and anal incontinence is high in this group of morbidly obese women as compared with the general population. Studies are needed to determine the effect of weight loss on urinary and anal incontinence symptoms in the morbidly obese woman.

Sexual functioning after total compared with supracervical hysterectomy: a randomized trial.

OBJECTIVE: To compare sexual functioning and health-related quality-of-life outcomes of total abdominal hysterectomy (TAH) and supracervical hysterectomy (SCH) among women with symptomatic uterine leiomyomata or abnormal uterine bleeding refractory to hormonal management. METHODS: We randomly assigned 135 women scheduled to undergo abdominal hysterectomy in 4 U.S. clinical centers to either a total or supracervical procedure. The primary outcome was sexual functioning at 2 years, as assessed by the Medical Outcomes Study Sexual Problems Scale. Secondary outcomes included specific aspects of sexual functioning and health-related quality-of-life at 6 months and 2 years. RESULTS: Sexual problems improved dramatically in both randomized groups during the first 6 months and plateaued by 1 year. Health-related quality-of-life scores also improved in both groups. At 2 years, both groups reported few problems with sexual functioning (mean score on the Sexual Problems Scale for SCH group 82, TAH group 80, on a 0-to-100 scale with 100 indicating an absence of problems; difference = +2.95% confidence interval -8 to +11), and there were no significant differences between groups. CONCLUSION: Supracervical and total abdominal hysterectomy result in similar sexual functioning and health-related quality of life during 2 years of follow-up. This information can help guide physicians as they discuss surgical options with their patients.

Regret, satisfaction, and symptom improvement: analysis of the impact of partial colpocleisis for the management of severe pelvic organ prolapse.

OBJECTIVE: The purpose of this study was to assess a cohort of patients who underwent a colpocleisis procedure more than 1 year post operation to determine: 1) the proportion of patients who regretted having the procedure, 2) patient satisfaction with the procedure, and 3) changes in symptom severity after surgery. STUDY DESIGN: Using the University of Alabama at Birmingham (UAB) Genitourinary Disorders Center database, a prospective analysis was performed on 54 patients who underwent colpocleisis between August 1996 and April 2003. From August to October of 2004, participants were contacted by an investigator not involved with the surgery and were asked 1) "do you regret having your surgery, and, if so, why?," 2) "how satisfied are you with your progress (completely, somewhat, or not)?," and 3) to repeat the short form Incontinence Impact Questionnaire/Urogenital Distress Inventory (IIQ-7/UDI-6). RESULTS: Fifty-nine percent (32/54) of potential candidates participated in the study. Nine percent (3/32) of patients regretted having colpocleisis performed. Fifty-seven percent (16/28) were completely satisfied, 29% (8/28) somewhat satisfied, and 14% (4/28) not satisfied. Mean IIQ score improved significantly from 40.9 (+/-31.7) at baseline to 14.1 (+/-26.7) at last interview (P = .003). Mean UDI score improved significantly from 63.1 (+/-24.3) at baseline to 24.2 (+/-26.7) at last interview (P = .001). There was a negative correlation between change in UDI scores with time since procedure (r = -.397, P = .055) and age (r = -.435, P = .034). CONCLUSION: Few patients reported regret after partial colpocleisis. There was a high rate of patient satisfaction and significant symptom improvement more than a year post surgery. Stable but smaller improvements were reported with longer time from surgery and increasing age.

Predictors of outcome in the behavioral treatment of urinary incontinence in women.

OBJECTIVE: To identify predictors of outcome of a multicomponent behavioral training program for urge and stress incontinence in women. METHODS: This report is a secondary analysis of data from three prospective, randomized, clinical trials testing behavioral interventions for urinary incontinence. Participants were a volunteer sample of 258 ambulatory, nondemented, community-dwelling women, aged 40-92 years, with stress, urge, or mixed urinary incontinence. Participants received 8 weeks (four visits) of multicomponent behavioral training in each study. The relationship between a number of variables and treatment success were explored by univariate and multivariable logistic regression analyses. RESULTS: Successful treatment of predominantly urge incontinence (75% reduction of incontinent episodes as recorded on bladder diary) was associated with not wearing any form of protection for incontinence (P = .045; 95% confidence interval [CI] .282, .987). Achieving total continence (100% reduction) was associated with fewer incontinent episodes at baseline (P < .001; 95% CI .138, .557), previous surgery for incontinence (P = .021; 95% CI 1.169, 6.543), and lower education level (P = .022; 95% CI .175, .871). Successful treatment of predominantly stress incontinence (75% reduction) was related to not having previous evaluation or treatment for incontinence (P = .001; 95% CI .026, .415), and fewer incontinent episodes on baseline bladder diary (P = .026; 95% CI .210, .907). Outcomes were not associated with age, race, type of incontinence, or a number of other variables reflecting medical history, obstetric history, medications, pelvic examination, body mass index, urodynamic parameters, or psychological distress. CONCLUSION: Aside from indicators of severity and previous treatment, there were few associations between baseline clinical variables and outcome of behavioral treatment.

A randomized comparison of total or supracervical hysterectomy: surgical complications and clinical outcomes.

OBJECTIVE: To compare surgical complications and clinical outcomes after total versus supracervical abdominal hysterectomy for control of abnormal uterine bleeding, symptomatic uterine leiomyomata, or both. METHODS: We conducted a randomized intervention trial in four US clinical centers among 135 patients who had abdominal hysterectomy for symptomatic uterine leiomyomata, abnormal uterine bleeding refractory to hormonal treatment, or both. Patients were randomly assigned to receive a total or supracervical hysterectomy performed using the surgeon's customary technique. Using an intention-to-treat approach, we compared surgical complications and clinical outcomes for 2 years after randomization. RESULTS: Sixty-eight participants were assigned to supracervical hysterectomy (SCH) and 67 to total abdominal hysterectomy (TAH). Hysterectomy by either technique led to statistically significant reductions in most symptoms, including pelvic pain or pressure, back pain, urinary incontinence, and voiding dysfunction. Patients randomly assigned to (SCH) tended to have more hospital readmissions than those randomized to TAH, but this difference was not statistically significant. There were no statistically significant differences in the rate of complications, degree of symptom improvement, or activity limitation. Participants weighing more than 100 kg at study entry were twice as likely to be readmitted to the hospital during the 2-year follow-up period (relative risk [RR] 2.18, 95% confidence interval [CI] 1.06, 4.48, P=.034). CONCLUSION: We found no statistically significant differences between (SCH) and TAH in surgical complications and clinical outcomes during 2 years of follow-up.

Resource use for total and supracervical hysterectomies: results of a randomized trial.

OBJECTIVE: Hysterectomy is the most common major surgical procedure performed in the United States for nonobstetric reasons. Although most hysterectomies include removal of the cervix, the rate of supracervical procedures has increased in recent years. To provide evidence about the outcomes of both types of hysterectomy, we conducted a randomized clinical trial of total (TAH) or supracervical (SCH) hysterectomy (the "TOSH" trial). We report here an analysis of 24-month resource use by patients in this trial. METHODS: A randomized controlled trial was performed at 3 clinical centers to compare resources used by 120 patients who received a total or supracervical abdominal hysterectomy. Service use during a 24-month follow-up period was identified from medical and billing records and patient reports. Each service used was assigned a relative value, which was then converted into 2002 U.S. dollars. RESULTS: Overall resource use was similar in the 2 study groups in the first 12 months after randomization (TAH 5,870 US dollars; SCH 6,018 US dollars; 95% confidence interval for difference -960 US dollars, 1,255 US dollars; P <.79) and for the full 24 months (TAH 6,448 US dollars; SCH 7,479 US dollars; 95% confidence interval for difference -533 US dollars, 2,616 US dollars; P <.20). In exploratory multivariable analyses, resource use was significantly associated with baseline body mass index greater than or equal to 35 kg/m(2) (8,440 US dollars versus 6,398 US dollars, P =.02) and heavy bleeding (7,550 US dollars versus 5,368 US dollars, P =.02). CONCLUSION: We conclude that the use of medical care resources over a 24-month period is comparable for total and supracervical hysterectomy. The association of a woman's weight and bleeding pattern with subsequent resource use requires further investigation.

Hysterectomy versus expanded medical treatment for abnormal uterine bleeding: clinical outcomes in the medicine or surgery trial.

OBJECTIVE: To compare clinical outcomes after randomization to hysterectomy versus medical treatment in patients with chronic abnormal uterine bleeding refractory to medroxyprogesterone acetate. METHODS: We randomly assigned 63 premenopausal women with abnormal uterine bleeding refractory to cyclic medroxyprogesterone acetate treatment to receive either a hysterectomy or expanded medical treatment. Within each randomized group, the specific treatment approach was determined by patient and provider preference. The primary analysis compared changes in clinical outcomes at 6 and 24 months by using an intention-to-treat approach. Secondary as-treated analyses after adjustment for baseline covariates compared participants randomly assigned to medical treatment who continued the medical approach with those who crossed over to hysterectomy. RESULTS: The intention-to-treat analyses at 6 months revealed greater symptom improvement in the hysterectomy group than in the medicine group for pelvic pain (P <.01), urinary urgency (P =.03), incomplete bladder emptying (P =.03), breast pain (P =.02), and cessation of vaginal bleeding (87% versus 11%, P <.001). Seventeen of 32 women assigned to medicine (53%) eventually crossed over and received a hysterectomy, and by 24 months the statistically significant differences by intention-to-treat were limited to greater improvement in hot flushes (P <.01) and cessation of vaginal bleeding (P <.01). Within-group analyses at year 2 showed statistically significant improvements from baseline on most symptoms for women who had a hysterectomy, whether through randomization or crossover. Women remaining on medical treatments had statistically significant improvements in pelvic pain, pelvic/bladder pressure, and stress incontinence. In a nonrandomized comparison with women who remained on medical treatments through year 2, those crossing over to hysterectomy experienced greater improvements in bleeding (P <.01), pelvic pain (P <.01), low back pain (P =.02), breast pain (P =.01), urinary frequency (P =.01), and urgency (P =.02). However, they also experienced more days off from work or usual activities (P <.01) and more days spent in bed (P <.01) than those who remained on medicine. CONCLUSION: For patients with abnormal uterine bleeding refractory to medroxyprogesterone acetate, hysterectomy is superior to expanded efforts with oral medications for alleviating clinical symptoms but may lead to more days of restricted activity.