Robert L. Holley

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.)

Douching and endometritis: results from the PID evaluation and clinical health (PEACH) study.

Background Douching has been related to risk of pelvic inflammatory disease (PID). Goal To examine the association between douching and PID in a large, multicenter, clinical trial of PID after adjustment for race/ethnicity. Study Design Interviews were conducted with 654 women who had signs and symptoms of PID. Vaginal Gram stains and upper genital tract pathology/cultures were obtained from all the women. Women with evidence of plasma cell endometritis and/or gonococcal or chlamydial upper genital tract infections were compared with women who had neither endometritis nor upper genital tract infection. Results Women with endometritis or upper genital tract infection were more likely to have douched more than once a month or within 6 days of enrollment than women who never douched. These associations remained after adjustment for confounding factors, after analysis of black women only; and among women with normal or intermediate vaginal flora but not bacterial vaginosis. Conclusion Among a predominantly black group of women with clinical PID, frequent and recent douching was associated with endometritis and upper genital tract infection.

Design of the PID Evaluation and Clinical Health (PEACH) Study

This paper describes the PID Evaluation and Clinical Health Study (PEACH), a multicenter, randomized clinical trial designed to compare treatment with outpatient and inpatient antimicrobial regimens among women with pelvic inflammatory disease (PID). PEACH is the first trial to evaluate the effectiveness and cost-effectiveness of currently recommended antibiotic combinations in preventing infertility, ectopic pregnancy, chronic pelvic pain, recurrent PID, and other health outcomes. It is also the largest prospective study of PID ever conducted in North America. We describe the PEACH studys specific aims, study organization, patient selection criteria, conditions for exclusion, data collected upon entry, randomization and treatment, adherence measures, follow-up activities, quality-of-life measures, outcomes, and statistical analyses. In the first 11 months of enrollment (March 1996-January 1997), 312 women were randomized. Of eligible women, 59% consented to enroll. Participating women are primarily black (72%) and young (mean age 24 years). After a median of 5.5 months of follow-up, we were in contact with 95% of study participants. The PEACH study will provide a rationale for selecting between inpatient and outpatient antibiotic treatment, the two most common treatment strategies, for PID.

Predictors of chronic pelvic pain in an urban population of women with symptoms and signs of pelvic inflammatory disease.

Objective: The objective of this study was to assess the risk profile for chronic pelvic pain (CPP) after pelvic inflammatory disease (PID). Study: Multivariate logistic regression was used to assess risk factors for CPP in a longitudinal study of 780 predominately black, urban women with clinically suspected PID: complaints of acute pain (<30 days); a clinical finding of pelvic tenderness; and leukorrhea, mucopurulent cervicitis, or untreated gonococcal or chlamydial cervicitis. CPP was defined as pain reported at ≥2 consecutive interviews conducted every 3 to 4 months for 2 to 5 years. Results: Nonblack race (odds ratio [OR], 2.17; 95% confidence interval [CI], 1.31–3.58), being married (OR, 2.06; 95% CI, 1.02–4.18), a low SF-36 mental health composite score (OR, 2.71; 95% CI, 1.69–4.34), ≥2 prior PID episodes (OR, 2.84; 95% CI, 1.07–7.54), and smoking (OR, 1.65; 95% CI, 1.01–2.71) independently predicted CPP. Histologic endometritis or evidence of endometrial Neisseria gonorrhoeae or Chlamydia trachomatis infection was negatively associated with CPP (OR, 0.69; 95% CI, 0.44–1.10). Conclusions: A range of demographic, clinical, historical, and behavioral factors predict CPP after PID.

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

The association of interleukin 6 with clinical and laboratory parameters of acute pelvic inflammatory disease

OBJECTIVE We sought (1) to determine whether interleukin 6 levels are increased in plasma and cervical secretions and endometrial tissue obtained from women with a clinical diagnosis of pelvic inflammatory disease, (2) to determine whether interleukin 6 levels in these sample sites reflected the clinical severity of acute infection, and (3) to determine whether interleukin 6 levels in endometrial tissue obtained from these women were higher in the presence of histologic endometritis. STUDY DESIGN We performed a prospective pilot study on 20 women with a clinical diagnosis of pelvic inflammatory disease (patients) and then compared them with 20 women presenting to the gynecology clinic without pelvic complaints (control subjects). Interleukin 6 levels were measured by enzyme-linked immunologic testing in plasma, cervical secretions, and endometrial biopsy specimens. RESULTS Cervical interleukin 6 levels were higher in patients than control subjects (median, 317 vs 111 pg/mL; P =.003). Among women with pelvic inflammatory disease, statistically significant positive correlations were noted between the clinical severity score and the erythrocyte sedimentation rate (r = 0.45; P =.04), the clinical severity score and the white blood cell count (r = 0.49; P =.03), the plasma interleukin 6 levels and the erythrocyte sedimentation rate (r = 0.55; P =.02), and the plasma interleukin 6 levels and the white blood cell count (r = 0.54, P =.01). Endometrial tissue interleukin 6 levels were also higher in patients with versus those without histologic endometritis (median, 427 vs 17 pg/mL; P =.004). CONCLUSION In this pilot study interleukin 6 levels in cervical secretions were significantly higher in women with pelvic inflammatory disease versus those without pelvic inflammatory disease. In women with pelvic inflammatory disease, endometrial tissue samples with histologic evidence of endometritis were observed to have higher levels of interleukin 6. Interleukin 6 may be a useful adjunct to the clinical diagnosis of pelvic inflammatory disease.

The cost of preoperative urodynamics: A secondary analysis of the ValUE trial

Urodynamic studies (UDS) are generally recommended prior to surgical treatment for stress urinary incontinence (SUI), despite insufficient evidence that it impacts treatment plans or outcomes in patients with uncomplicated SUI. This analysis aimed to calculate the cost incurred when UDS was performed as a supplement to a basic office evaluation and to extrapolate the potential savings of not doing UDS in this patient population on a national basis.

Laparoscopic and Psychologic Evaluation of Women with Chronic Pelvic Pain

Objective: Pelvic pain can account for up to 40 percent of laparoscopies performed by gynecologists. This report compares the psychological profiles and efficacy of laparoscopic surgery at long-term follow-up in a series of laparoscopy-positive and laparoscopy-negative patients with chronic pelvic pain. Method: A retrospective chart review was performed on patients diagnosed with chronic pelvic pain combined with postoperative written questionnaires and self-rating scales. These questionnaires were used to assess long-term post laparoscopy follow-up of the physical and psychological status of women with positive findings at laparoscopy compared to those women with negative findings. Results: There were no statistically significant demographic differences between respondents and nonrespondents. In the respondents, no statistically significant differences were noted even with long-term follow-up when comparing responses of the laparoscopy-positive and laparoscopy-negative groups on the above questionnaires. Conclusion: Though reporting modest improvement in pelvic pain since laparoscopy, both groups reported a high incidence of anxiety, depression, physical worries, and marital/sexual problems.

Testing and validation of a low-cost cystoscopy teaching model: a randomized controlled trial.

OBJECTIVE: To estimate whether the use of a low-cost cystoscopy model effectively trains residents in cystourethroscopy and to validate the model as a teaching tool. METHODS: A randomized, controlled, and evaluator-blinded study was performed. Twenty-nine obstetrician–gynecologist residents had access to fresh-frozen cadavers on which baseline cystoscopic skills were assessed using the validated Objective Structured Assessment of Technical Skills checklists for cystourethroscopy. Subsequently, residents were randomized to one of two arms, a didactic study arm using the cystoscopy model and a control arm. Repeated technical skills testing was performed. RESULTS: The study group demonstrated statistically significant decreases in cystoscope assembly time (128.8 seconds at baseline to 54.9 seconds postintervention; P=.005), and increases in task-specific checklist scores (from 59.3 at baseline to 92.9 postintervention; P<.001) and in global rating scale scores (from 61.0 at baseline to 87.8 postintervention; P<.001). Further, there was a significant improvement in task-specific checklist (P<.001), global rating scale (P=.002), and knowledge quiz scores (P=.011) in the study arm compared with the control arm. CONCLUSION: Use of the bladder model exhibited validity in enhancing performance and knowledge of cystourethroscopy among ob-gyn residents. LEVEL OF EVIDENCE: I

Effects of transvaginal repair of symptomatic rectocele on symptom-specific distress and impact on quality of life

To determine symptom‐specific distress and quality‐of‐life impact outcomes among women who had undergone transvaginal repair of symptomatic rectocele.