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.)

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

OBJECTIVE: To determine symptom-specific distress and quality-of-life impact outcomes among women who had undergone transvaginal repair of symptomatic rectocele. METHODS: Women who underwent transvaginal repair of symptomatic rectocele at the University of Alabama at Birmingham, USA, between April 2006 and June 2009 were included in a retrospective case series. Minimum follow-up was 1 year post-surgery. Women who underwent concomitant surgery, other than perineoplasty and/or midurethral sling, were excluded. End points were assessed using the Pelvic Floor Distress Inventory (PFDI-20) and the Pelvic Floor Impact Questionnaire (PFIQ-7). RESULTS: Overall, 113 women underwent repair of symptomatic rectocele, of whom 69 (61.1%) completed preoperative questionnaires and 66 (58.4%) responded to follow-up questionnaires. Mean time from surgery was 31.2±11.2 months. PFDI-20 and PFIQ-7 scores were significantly improved following surgery, with a median pre- and post-surgery difference of 35.4 (P<0.001) and 31.0 (P=0.002), respectively. CONCLUSION: Patients who underwent transvaginal repair of symptomatic rectocele reported improvements in symptom-specific distress and impact on quality of life.

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.

Synthetic graft use in vaginal prolapse surgery: objective and subjective outcomes.

INTRODUCTION AND HYPOTHESIS: This study reports 1-year outcomes in women who underwent transvaginal pelvic organ prolapse (POP) surgery with Prolift transvaginal mesh. METHODS: Pre- and postoperative objective vaginal Pelvic Organ Prolapse Quantification (POP-Q) and subjective symptom and impact assessments (Pelvic Floor Distress Inventory (PFDI)-20 and Pelvic Floor Impact Questionnaire (PFIQ)-7, respectively) were performed. Postoperative vaginal tenderness, stricture, and patient satisfaction were also obtained. Paired t tests were utilized for analysis. RESULTS: Mean age was 61.8 +/- 9.8 years; mean follow-up interval was 425.0 +/- 80.0 days (range, 237-717). POP-Q measurements of Ba, Bp, and C were significantly improved (all p values

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 >or=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), >or=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.

A randomized, double-blind clinical trial of vaginal acidification versus placebo for the treatment of symptomatic bacterial vaginosis.

BACKGROUND AND OBJECTIVES: Vaginal acidification has been suggested as a means of normalizing the vaginal flora. GOAL: The purpose of this study was to determine the effectiveness of an acetic acid-based vaginal gel in the treatment of bacterial vaginosis (BV). STUDY DESIGN: Forty-four patients with BV were enrolled in a randomized, double-blind clinic trial. Of these, 29 were evaluable. Patients were randomized to receive either 5 mL acetic acid gel (n = 14) or placebo gel (n = 15) intravaginally twice daily for 7 days. Clinical criteria and vaginal Gram stain scores were compared between the initial visit and at 2 weeks after initiating therapy. RESULTS: No significant differences were noted when comparing drug and placebo in terms of subjective or clinical improvement or improvement in Gram stain smears for bacterial vaginosis. CONCLUSION: Vaginal acidification with an acetic acid gel formulated to pH 3.9 to 4.1 was ineffective therapy for bacterial vaginosis.

Cadaveric fascia lata sling for stress urinary incontinence: a prospective quality-of-life analysis.

OBJECTIVE: The purpose of this study was to describe the effects of full-length cadaveric fascia lata (CFL) sling on quality-of-life outcomes. STUDY DESIGN: Patients were 102 women (aged 29 to 87 years) who underwent the sling procedure for stress incontinence associated with intrinsic sphincter deficiency. They were followed up at 12, 24, 36, and 48 months with the Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6), and a patient satisfaction questionnaire. RESULTS: Mean IIQ score declined from 55.1 before surgery to 11.0 at 12 months (P<.001). Mean UDI score declined from 67.1 to 28.0 at 12 months (P<.01). At 12 months, 79.7% of patients reported that leakage was better or much better, and 90.2% reported that they were somewhat or completely satisfied with their progress. Results were maintained throughout the 48-month follow-up period. CONCLUSION: The CFL sling procedure has an enduring beneficial effect on lower urinary tract symptoms and quality of life.

Endometritis does not predict reproductive morbidity after pelvic inflammatory disease.

OBJECTIVE: We investigated the association between endometritis and reproductive morbidity. STUDY DESIGN: Participants were 614 women in the PID Evaluation and Clinical Health (PEACH) Study with pelvic pain, pelvic organ tenderness, and leukorrhea, mucopurulent cervicitis, or untreated cervicitis. We compared women with endometritis (>or=5 neutrophils or >or=2 plasma cells), Neisseria gonorrhoeae or Chlamydia trachomatis upper genital tract infection (UGTI) or both to women without endometritis/UGTI for outcomes of pregnancy, infertility, recurrent pelvic inflammatory disease (PID), and chronic pelvic pain (CPP), adjusting for age, race, education, PID history, and baseline infertility. RESULTS: Endometritis/UGTI was not associated with reduced pregnancy (odds ratio [OR] 0.8, 95% CI 0.6-1.2) or elevated infertility (OR 1.0, 95% CI 0.6-1.6), recurrent PID (OR 0.6, 95% CI 0.4-0.9), or CPP (OR 0.6, 95% CI 0.4-0.9). PEACH participants with and without endometritis/UGTI had higher age- and race-specific pregnancy rates than 1997 national rates. CONCLUSION: Among women with clinically suspected mild-to-moderate PID treated with standard antibiotics, endometritis/UGTI was not associated with reproductive morbidity.

Effectiveness of inpatient and outpatient treatment strategies for women with pelvic inflammatory disease: results from the Pelvic Inflammatory Disease Evaluation and Clinical Health (PEACH) Randomized Trial.

OBJECTIVE: Pelvic inflammatory disease (PID) is a common and morbid intraperitoneal infection. Although most women with pelvic inflammatory disease are treated as outpatients, the effectiveness of this strategy remains unproven. STUDY DESIGN: We enrolled 831 women with clinical signs and symptoms of mild-to-moderate pelvic inflammatory disease into a multicenter randomized clinical trial of inpatient treatment initiated by intravenous cefoxitin and doxycycline versus outpatient treatment that consisted of a single intramuscular injection of cefoxitin and oral doxycycline. Long-term outcomes were pregnancy rate, time to pregnancy, recurrence of pelvic inflammatory disease, chronic pelvic pain, and ectopic pregnancy. RESULTS: Short-term clinical and microbiologic improvement were similar between women randomized to the inpatient and outpatient groups. After a mean follow-up period of 35 months, pregnancy rates were nearly equal (42.0% for outpatients and 41.7% for inpatients). There were also no statistically significant differences between outpatient and inpatient groups in the outcome of time to pregnancy or in the proportion of women with pelvic inflammatory disease recurrence, chronic pelvic pain, or ectopic pregnancy. CONCLUSION: Among women with mild-to-moderate pelvic inflammatory disease, there was no difference in reproductive outcomes between women randomized to inpatient treatment and those randomized to outpatient treatment.