Thomas L. Wheeler

Defining Success After Surgery for Pelvic Organ Prolapse

OBJECTIVES: To describe pelvic organ prolapse surgical success rates using a variety of definitions with differing requirements for anatomic, symptomatic, or re-treatment outcomes. METHODS: Eighteen different surgical success definitions were evaluated in participants who underwent abdominal sacrocolpopexy within the Colpopexy and Urinary Reduction Efforts trial. The participants’ assessments of overall improvement and rating of treatment success were compared between surgical success and failure for each of the definitions studied. The Wilcoxon rank sum test was used to identify significant differences in outcomes between success and failure. RESULTS: Treatment success varied widely depending on definition used (19.2–97.2%). Approximately 71% of the participants considered their surgery “very successful,” and 85.2% considered themselves “much better” than before surgery. Definitions of success requiring all anatomic support to be proximal to the hymen had the lowest treatment success (19.2–57.6%). Approximately 94% achieved surgical success when it was defined as the absence of prolapse beyond the hymen. Subjective cure (absence of bulge symptoms) occurred in 92.1% while absence of re-treatment occurred in 97.2% of participants. Subjective cure was associated with significant improvements in the patient’s assessment of both treatment success and overall improvement, more so than any other definition considered (P<.001 and <.001, respectively). Similarly, the greatest difference in symptom burden and health-related quality of life as measured by the Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire scores between treatment successes and failures was noted when success was defined as subjective cure (P<.001). CONCLUSION: The definition of success substantially affects treatment success rates after pelvic organ prolapse surgery. The absence of vaginal bulge symptoms postoperatively has a significant relationship with a patient’s assessment of overall improvement, while anatomic success alone does not. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00065845. LEVEL OF EVIDENCE: II

Graft use in transvaginal pelvic organ prolapse repair: A systematic review

OBJECTIVE: To estimate the anatomic and symptomatic efficacy of graft use in transvaginal prolapse repair and to estimate the rates and describe the spectrum of adverse events associated with graft use. DATA SOURCES: Eligible studies, published between 1950 and November 27, 2007, were retrieved through Medline and bibliography searches. METHODS OF STUDY SELECTION: To assess anatomic and symptomatic efficacy of graft use, we used transvaginal prolapse repair studies that compared graft use with either native tissue repair or repair with a different graft. To estimate rates of adverse events from graft use, all comparative studies and case series with at least 30 participants were included. For spectrum of adverse events, all study designs were included. TABULATION, INTEGRATION AND RESULTS: Eligible studies were extracted onto standardized forms by one reviewer and confirmed by a second reviewer. Comparative studies were classified by vaginal compartment (anterior, posterior, apical, or multiple), graft type (biologic, synthetic-absorbable, synthetic nonabsorbable) and outcome (anatomic, symptomatic). We found 16 comparative studies, including six randomized trials, 37 noncomparative studies with at least 30 women, 11 case series with fewer than 30 women, and 10 case reports of adverse events. One randomized trial and one prospective comparative study evaluating synthetic, nonabsorbable graft use in the anterior compartment reported favorable anatomic and symptomatic outcomes with graft use. Data regarding graft use for posterior and apical compartments or for biologic or synthetic absorbable graft use in the anterior compartment were insufficient to determine efficacy. Rates and spectrum of adverse events associated with graft use included bleeding (0–3%), visceral injury (1–4%), urinary infection (0–19%), graft erosion (0–30%), and fistula (1%). There were insufficient data regarding dyspareunia, sexual, voiding, or defecatory dysfunction. CONCLUSION: Overall, the existing evidence is limited to guide decisions regarding whether to use graft materials in transvaginal prolapse surgery. Adequately powered randomized trials evaluating anatomic and symptomatic efficacy as well as adverse events are needed.

Sling surgery for stress urinary incontinence in women: a systematic review and metaanalysis.

OBJECTIVE Understanding the long-term comparative effectiveness of competing surgical repairs is essential as failures after primary interventions for stress urinary incontinence (SUI) may result in a third of women requiring repeat surgery. STUDY DESIGN We conducted a systematic review including English-language randomized controlled trials from 1990 through April 2013 with a minimum 12 months of follow-up comparing a sling procedure for SUI to another sling or Burch urethropexy. When at least 3 randomized controlled trials compared the same surgeries for the same outcome, we performed random effects model metaanalyses to estimate pooled odds ratios (ORs). RESULTS For midurethral slings (MUS) vs Burch, metaanalysis of objective cure showed no significant difference (OR, 1.18; 95% confidence interval [CI], 0.73-1.89). Therefore, we suggest either intervention; the decision should balance potential adverse events (AEs) and concomitant surgeries. For women considering pubovaginal sling vs Burch, the evidence favored slings for both subjective and objective cure. We recommend pubovaginal sling to maximize cure outcomes. For pubovaginal slings vs MUS, metaanalysis of subjective cure favored MUS (OR, 0.40; 95% CI, 0.18-0.85). Therefore, we recommend MUS. For obturator slings vs retropubic MUS, metaanalyses for both objective (OR, 1.16; 95% CI, 0.93-1.45) and subjective cure (OR, 1.17; 95% CI, 0.91-1.51) favored retropubic slings but were not significant. Metaanalysis of satisfaction outcomes favored obturator slings but was not significant (OR, 0.77; 95% CI, 0.52-1.13). AEs were variable between slings; metaanalysis showed overactive bladder symptoms were more common following retropubic slings (OR, 1.413; 95% CI, 1.01-1.98, P = .046). We recommend either retropubic or obturator slings for cure outcomes; the decision should balance AEs. For minislings vs full-length MUS, metaanalyses of objective (OR, 4.16; 95% CI, 2.15-8.05) and subjective (OR, 2.65; 95% CI, 1.36-5.17) cure both significantly favored full-length slings. Therefore, we recommend a full-length MUS. CONCLUSION Surgical procedures for SUI differ for success rates and complications, and both should be incorporated into surgical decision-making. Low- to high-quality evidence permitted mostly level-1 recommendations when guidelines were possible.

The Minimum Important Differences for the Urinary Scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire

OBJECTIVE We sought to estimate the minimum important difference (MID) for the Urinary Distress Inventory (UDI), UDI-stress subscale of the Pelvic Floor Distress Inventory, and Urinary Impact Questionnaire (UIQ) of the Pelvic Floor Impact Questionnaire. STUDY DESIGN We calculated MID using anchor- and distribution-based approaches from a randomized trial for nonsurgical stress incontinence treatment. Anchors included a global impression of change, incontinence episodes from a urinary diary, and the Incontinence Severity Index. Effect size and standard error of measurement were the distribution methods used. RESULTS Anchor-based MIDs ranged from -22.4 to -6.4 points for the UDI, -16.5 to -4.6 points for the UDI-stress, and -17.0 to -6.5 points for the UIQ. These data were supported by 2 distribution-based estimates. CONCLUSION Reasonable estimates of MID are 11, 8, and 16 points for the UDI, UDI-stress subscale, and UIQ, respectively. Statistically significant improvements that meet these thresholds should be considered clinically important.

Nonsurgical management of heavy menstrual bleeding: a systematic review.

OBJECTIVE: To compare the effectiveness of nonsurgical abnormal uterine bleeding treatments for bleeding control, quality of life (QOL), pain, sexual health, patient satisfaction, additional treatments needed, and adverse events. DATA SOURCES: MEDLINE, Cochrane databases, and Clinicaltrials.gov were searched from inception to May 2012. We included randomized controlled trials of nonsurgical treatments for abnormal uterine bleeding presumed secondary to endometrial dysfunction and abnormal uterine bleeding presumed secondary to ovulatory dysfunction. Interventions included the levonorgestrel intrauterine system, combined oral contraceptive pills (OCPs), progestins, nonsteroidal anti-inflammatory drugs (NSAIDs), and antifibrinolytics. Gonadotropin-releasing hormone agonists, danazol, and placebo were allowed as comparators. METHODS OF STUDY SELECTION: Two reviewers independently screened 5,848 citations and extracted eligible trials. Studies were assessed for quality and strength of evidence. TABULATION, INTEGRATION, AND RESULTS: Twenty-six articles met inclusion criteria. For reduction of menstrual bleeding in women with abnormal uterine bleeding presumed secondary to endometrial dysfunction, the levonorgestrel intrauterine system (71–95% reduction), combined OCPs (35–69% reduction), extended cycle oral progestins (87% reduction), tranexamic acid (26–54% reduction), and NSAIDs (10–52% reduction) were all effective treatments. The levonorgestrel intrauterine system, combined OCPs, and antifibrinolytics were all superior to luteal-phase progestins (20% increase in bleeding to 67% reduction). The levonorgestrel intrauterine system was superior to combined OCPs and NSAIDs. Antifibrinolytics were superior to NSAIDs for menstrual bleeding reduction. Data were limited on other important outcomes such as QOL for women with abnormal uterine bleeding presumed secondary to endometrial dysfunction and for all outcomes for women with abnormal uterine bleeding presumed secondary to ovulatory dysfunction. CONCLUSION: For the reduction in mean blood loss in women with heavy menstrual bleeding presumed secondary to abnormal uterine bleeding presumed secondary to endometrial dysfunction, we recommend the use of the levonorgestrel intrauterine system over OCPs, luteal-phase progestins, and NSAIDs. For other outcomes (QOL, pain, sexual health, patient satisfaction, additional treatments needed, and adverse events) and for treatment of abnormal uterine bleeding presumed secondary to ovulatory dysfunction, we were unable to make recommendations based on the limited available data.

Delivery method, anal sphincter tears and fecal incontinence: new information on a persistent problem.

Purpose of review To review the risk factors for anal sphincter tears during vaginal delivery and their association with fecal incontinence symptoms. Recent findings Recent evidence links sphincter tears with fecal incontinence, which has a significant negative impact on quality of life. The Childbirth and Pelvic Symptoms cohort study reported that the incidence and severity of fecal incontinence was increased in primiparous women experiencing a sphincter tear. Risk factors for tear included forceps, occiput posterior, vacuum delivery, prolonged second stage of labor and epidural. Using cesarean delivery to prevent fecal incontinence has not been justified, but the confluence of these risk factors in the context of labor management may be important in deciding on earlier intervention with cesarean delivery. Internal anal sphincter defects impact fecal incontinence, highlighting the identification and repair of the internal anal sphincter for future research and clinical applications. Routine episiotomy (or instrumentation) is not warranted, and there is no clear advantage to mediolateral episiotomy or overlapping sphincter repair. Postpartum ultrasound of the sphincter complex may have an emerging role. Summary The modifiable risk factors of routine episotomy and instrumented delivery are associated with sphincter tear; definitive recommendations for labor management remain unclear in preventing fecal incontinence.

Association between urinary incontinence and depressive symptoms in overweight and obese women.

OBJECTIVE The objective of the study was to determine the association between urinary incontinence (UI) and depressive symptoms. STUDY DESIGN The study was a cross-sectional study of 338 incontinent and overweight women at baseline in the Program to Reduce Incontinence by Diet and Exercise trial. Depressive symptoms were defined as a Beck Depression Inventory score of 10 or greater. UI frequency was determined by a 7-day voiding diary. Symptom bother and quality of life were determined using the Urogenital Distress Inventory (UDI) and the Incontinence Impact Questionnaire (IIQ). Multivariable regression was used to estimate the association between UI and depressive symptoms. RESULTS Women with depressive symptoms (n = 101) reported a higher mean number of UI episodes per week (28 vs 23; P = .005) and higher (worse) mean scores on the UDI (176 vs 162; P = .02) and IIQ (136 vs 97; P < .001) compared with women without depressive symptoms. The risk of having depressive symptoms increased with each 7-episode increase in UI per week (adjusted odds ratio [AOR], 1.10; 95% confidence interval [CI], 1.01-1.21), each 50-point increase in UDI (AOR, 1.27; 95% CI, 1.01-1.60), and each 50-point increase in IIQ (AOR, 1.44; 95% CI, 1.22-1.71). CONCLUSION Urinary incontinence frequency, symptom bother, and quality of life are independently associated with depressive symptoms in overweight and obese women.

A systematic review comparing hysterectomy with less-invasive treatments for abnormal uterine bleeding

STUDY OBJECTIVE To compare hysterectomy with less-invasive alternatives for abnormal uterine bleeding (AUB) in 7 clinically important domains. DESIGN Systematic review. SETTING Randomized clinical trials comparing bleeding, quality of life, pain, sexual health, satisfaction, need for subsequent surgery, and adverse events between hysterectomy and less-invasive treatment options. PATIENTS Women with AUB, predominantly from ovulatory disorders and endometrial causes. INTERVENTIONS Systematic review of the literature (from inception to January 2011) comparing hysterectomy with alternatives for AUB treatment. Eligible trials were extracted into standardized forms. Trials were graded with a predefined 3-level rating, and the strengths of evidence for each outcome were evaluated with the Grades for Recommendation, Assessment, Development and Evaluation system. MEASUREMENTS AND MAIN RESULTS Nine randomized clinical trials (18 articles) were eligible. Endometrial ablation, levonorgestrel intrauterine system, and medications were associated with lower risk of adverse events but higher risk of additional treatments than hysterectomy. Compared to ablation, hysterectomy had superior long-term pain and bleeding control. Compared with the levonorgestrel intrauterine system, hysterectomy had superior control of bleeding. No other differences between treatments were found. CONCLUSION Less-invasive treatment options for AUB result in improvement in quality of life but carry significant risk of retreatment caused by unsatisfactory results. Although hysterectomy is the most effective treatment for AUB, it carries the highest risk for adverse events.

Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial - Design and methods

Background The primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach. Purpose To present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation. Methods The challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network. Results The ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization. Limitations Given the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability. Conclusion Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible with regards to data collection and be constantly aware of unanticipated opportunities for unmasking. Future surgical trials should be aware of potential challenges in maintaining masking and collection of cost-related information. Clinical Trials 2009; 6: 162—171. http://ctj.sagepub.com

Endometriosis after laparoscopic supracervical hysterectomy with uterine morcellation: a case control study

STUDY OBJECTIVE To compare the incidence of new-onset endometriosis after laparoscopic supracervical hysterectomy (LSH) with uterine morcellation to traditional routes. DESIGN Single center case-control study (Canadian Task Force classification II-2) of hysterectomies performed from January 2006 through December 2008. PATIENTS Two hundred seventy-seven laparoscopic supracervical hysterectomies with morcellation (cases) and 187 transvaginal or abdominal hysterectomies without morcellation (controls) were performed from January 2006 through December 2008. INTERVENTIONS A total of 464 women underwent hysterectomy, 277 cases via laparoscopic supracervical approach (LSH) with morcellation and 187 performed either transvaginally or abdominally without morcellation. Repeat operative procedures were performed for other benign indications on 16 of 464 (3.5%) patients who had undergone prior hysterectomy. MEASUREMENTS AND MAIN RESULTS One hundred two patients had endometriosis at the time of hysterectomy diagnosed by pathologic evaluation or gross visualization. In those without endometriosis, repeat operative procedures were performed for pain and bleeding in 3.3% (12/362). Sixty percent (3/5) of patients treated with LSH and 28.6% (2/7) of the control group were found to have newly diagnosed endometriosis, conferring a rate of 1.4% (3/217) in the LSH group and 1.4% (2/145) in the control subjects. In patients with endometriosis, repeat operative procedures for pain or bleeding occurred in 2.9% (3/102): 3/60 patients treated with LSH and none in the control group (0/42). Two of these 3 patients undergoing a second surgery had recurrent/continued endometriosis. CONCLUSION Newly diagnosed endometriosis was noted in 1.4% of patients after hysterectomy, with a similar incidence between the LSH and control groups. Reoperation for those with endometriosis at the time of LSH with morcellation was infrequent, but endometriosis was usually found. Further research is needed to delineate risk factors for development of de novo endometriosis after hysterectomy.