Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7).

OBJECTIVE: To develop short forms of 2 valid and reliable condition-specific quality-of-life questionnaires for women with disorders of the pelvic floor including urinary incontinence, pelvic organ prolapse, and fecal incontinence (Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire). STUDY DESIGN: Data from the 100 women who contributed to the development and validation of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire long forms were used to develop the short-form questionnaires. All subsets regression analysis was used to find the items in each scale that best predicted the scale score on the respective long form. When different items appeared equivalent, a choice was made on item content. After development, the short forms and the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire long forms were administered preoperatively to 45 women with pelvic floor disorders scheduled to undergo surgery to evaluate the correlation between short and long forms in a second independent population. The short forms were readministered 3 to 6 months postoperatively to assess the responsiveness of the instruments. RESULTS: The short-form version of the Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Each short-form scale demonstrates significant correlation with their long-form scales (r=.86, r=.92, and r=.93, respectively, P<.0001). For the Pelvic Floor Impact Questionnaire short form, the previously developed short form for the Incontinence Impact Questionnaire-7 was used as a template. The 7 items identified in the previously developed Incontinence Impact Questionnaire-7 short form correlate highly with the Incontinence Impact Questionnaire long form (r=.96, P<.0001) as well as the long forms of the Colorectal-Anal Impact Questionnaire scale (r=.96, P<.0001) and the Pelvic Organ Prolapse Impact Questionnaire (r=.94, P<.0001). All subsets regression analysis did not identify any items or combination of items that correlated substantially better for any of the 3 scales. The scales of the Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire-7 maintained their excellent correlation to the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire long forms in the second independent sample (r=.88 to .94 for scales of Pelvic Floor Distress Inventory-20; r=.95 to .96 for scales of Pelvic Floor Impact Questionnaire-7, P<.0001 for all). The test-retest reliability of each scale was good to excellent (intraclass correlation coefficient 0.70 to 0.93, P<.001 for all scales). The scales and summary scores of the Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire-7 demonstrated moderate to excellent responsiveness 3 to 6 months after surgery. CONCLUSION: The Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire-7 are valid, reliable, and responsive short forms of 2 condition-specific quality-of-life questionnaires for women with pelvic floor disorders.

Duloxetine vs placebo in the treatment of stress urinary incontinence: a four-continent randomized clinical trial.

OBJECTIVES: To further assess, in a phase 3 study, treatment with duloxetine for women with stress urinary incontinence (SUI) in other geographical regions, including Argentina, Australia, Brazil, Finland, Poland, South Africa and Spain, as previous trials in North America and Europe provided evidence for the safety and efficacy of duloxetine as a pharmacological treatment for SUI in women. PATIENTS AND METHODS: The study included 458 women aged 27-79 years enrolled in a double-blind, placebo-controlled trial. The patients with predominantly SUI were identified using a validated clinical algorithm. They were randomly assigned to receive placebo (231) or duloxetine 40 mg twice daily (227) for 12 weeks. The primary outcome variables included the incontinence episode frequency (IEF) and the Incontinence Quality of Life (I-QOL) questionnaire. Van Elteren's test was used to analyse the percentage changes in IEF where the stratification variable was weekly baseline IEF (IEF < 14 and > or = 14). Analysis of covariance was used to analyse I-QOL scores. RESULTS: The mean baseline IEF was 18.4/week; 55% of patients had a baseline IEF of > or = 14. There was a significantly greater median decrease in IEF with duloxetine with placebo (54% vs 40%, P = 0.05), with comparable significant improvements in quality of life (I-QOL score increases of 10.3 vs 6.4, P = 0.007). The improvements with duloxetine were associated with significantly greater increases in voiding intervals than with placebo (20.4 vs 8.5 min, P < 0.001). The placebo response was 10.7% and 12.5% higher than those reported in two European and North American phase 3 trials. This may have been related to more patients being naïve for incontinence management in the current trial. Discontinuation rates for adverse events were 1.7% for placebo and 17.2% for duloxetine (P < 0.001), with nausea being the most common reason for discontinuation (3.1%); it was the most common adverse event with duloxetine, but was mild or moderate in most (81%), did not worsen in any patient and resolved within 7 days in 60% and within 1 month in 86% of continuing patients; 88% of women who experienced nausea while taking duloxetine completed the trial. CONCLUSIONS: These results show improvements in incontinence and quality of life with duloxetine 40 mg twice daily for 12 weeks that are in keeping with those reported in two other recently completed phase 3 trials in Europe and North America.

Effects of pelvic floor muscle training on strength and predictors of response in the treatment of urinary incontinence.

AIMS: The objectives of this study were (1) to determine the effect of training on pelvic floor muscle strength; (2) to determine whether changes in pelvic floor muscle strength correlate with changes in continence; and (3) to determine whether demographic characteristics, clinical incontinence severity indices, or urodynamic measures predict response to pelvic floor muscle training. METHODS: One hundred thirty-four women with urinary incontinence (95=genuine stress incontinence [GSI]; 19=detrusor instability [DI]; 20=mixed incontinence [GSI+DI]) were randomized to pelvic floor muscle training (n=67) or bladder training (n=67). Urinary diaries, urodynamic evaluation, and vaginal pressure measurements by using balloon manometry were performed at baseline and after 12 weeks of therapy. Primary outcome measures consisted of incontinent episodes per week and vaginal pressure measurements. RESULTS: Both treatment groups had a reduction in incontinent episodes (P

Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders.

OBJECTIVE: To evaluate the psychometric properties of the Pelvic Floor Distress Inventory (PFDI) and the Pelvic Floor Impact Questionnaire (PFIQ). METHODS: The PFDI and PFIQ are based on the structure and content of two previously validated questionnaires (the Urinary Distress Inventory [UDI] and the Incontinence Impact Questionnaire [IIQ]) and have additional questions regarding pelvic organ prolapse and colorectal dysfunction. The PFDI assesses symptom distress in women with pelvic floor disorders and has 3 scales: UDI (28 items), Colorectal-anal Distress Inventory (17 items), and Pelvic Organ Prolapse Distress Inventory (16 items). The PFIQ assesses life impact and also has 3 scales: IIQ, Colorectal-anal Impact Questionnaire, and the Pelvic Organ Prolapse Impact Questionnaire (31 items each). One hundred women with pelvic floor symptoms were enrolled and completed both the PFDI and PFIQ at baseline and again 1 week later. Patients underwent a comprehensive evaluation that included a structured history, Pelvic Organ Prolapse Quantitation, and a 1-week prospective bowel/bladder diary. Patients with urinary incontinence and stage III or IV pelvic organ prolapse also had a urodynamic evaluation. RESULTS: Each scale of the PFDI and PFIQ proved to be internally consistent (alphas: PFDI.82-.89; PFIQ.96-.97) and reproducible (interclass correlations: PFDI.86-.87; PFIQ.77-.92). Both the UDI and the IIQ significantly correlated with the number of urinary incontinence episodes per week (rho =.26, P <.05; rho =.46, P <.0001, respectively) and the number of pads used per week (rho =.26, P <.05; rho =.40, P <.0001, respectively). The Pelvic Organ Prolapse Distress Inventory and the Pelvic Organ Prolapse Impact Questionnaire significantly correlated with the stage of prolapse (rho =.32 and rho =.33, P <.01 each), and the Colorectal-anal Distress Inventory and Colorectal-anal Impact Questionnaire significantly correlated with the number of fecal incontinence episodes per month (rho =.49, P <.0001 and rho =.30, P <.01) and a diagnosis of defecatory dysfunction (rho =.47, P <.0001 and rho =.29, P <.01). The total time taken to complete both instruments averaged 23 minutes (range, 9-55). CONCLUSION: The PFDI and the PFIQ are reliable, valid, condition-specific quality of life instruments for women with pelvic floor disorders.

Vaginal mesh erosion after abdominal sacral colpopexy.

OBJECTIVE: Our goal was to compare the prevalence of vaginal mesh erosion between abdominal sacral colpopexy and various sacral colpoperineopexy procedures. STUDY DESIGN: We undertook a retrospective analysis of all sacral colpopexies and colpoperineopexies performed between March 1, 1992, and February 28, 1999. The patients were divided into the following 4 groups: abdominal sacral colpopexy, abdominal sacral colpoperineopexy, and 2 combined vaginal and abdominal colpoperineopexy groups, one with vaginal suture passage and the other with vaginal mesh placement. Survival analysis and Cox proportional hazards models were developed to examine erosion rates and time to erosion between groups. RESULTS: A total of 273 abdominal sacral vault suspensions were performed with the use of permanent synthetic mesh. There were 155 abdominal sacral colpopexies and 88 abdominal sacral colpoperineopexies. Among the 30 combined abdominal-vaginal procedures, 25 had sutures attached to the perineal body and brought into the abdominal field and 5 had mesh placed vaginally and brought into the abdominal field. Overall, mesh erosion was observed in 5.5% (15/273). The prevalence of mesh erosion was 3.2% (5/155) in the abdominal sacral colpopexy group and 4.5% (5/88) in the abdominal sacral colpoperineopexy group (P not significant). The rates of erosion when sutures or mesh was placed vaginally were 16% (4/25) and 40% (2/5), respectively, and were significantly increased in comparison with the rates for abdominal sacral colpopexy (hazard ratio, 5.4; 95% confidence interval, 1.6-18.0; P = .005; vs hazard ratio, 19.7; 95% confidence interval, 3.8-101.5; P < .001). These variables retained their significance after we controlled for other independent variables, including age, concomitant hysterectomy, concomitant posterior repair, and estrogen status. The median time to mesh erosion was 15.6 months for abdominal sacral colpopexy, 12.4 months for abdominal sacral colpoperineopexy, 9.0 months in the suture-only group (P < .005), and 4.1 months in the vaginal mesh group (P < .0001). CONCLUSIONS: The rate of mesh erosion is higher and the time to mesh erosion is shorter with combined vaginal-abdominal sacral colpoperineopexy with vaginal suture and vaginal mesh placement in comparison with abdominal sacral colpopexy.

Which women with stress incontinence require urodynamic evaluation?

OBJECTIVE: This study was undertaken to determine the predictive value of the symptom of stress urinary incontinence and to evaluate the ability of other factors suggested by a published Agency for Health Care Policy and Research guideline for the discrimination of patients unlikely to require urodynamic testing before surgical management. STUDY DESIGN: We evaluated 950 consecutive women without advanced (stage III or IV) pelvic organ prolapse who were referred with symptoms of incontinence. Incontinence was recorded by means of standard forms and was characterized as "any stress loss" (76.4%), "primarily stress loss" (58.9%), "stress loss only" (29.8%), "stress and urge loss" (52.2%), "urge loss only" (13.8%), "constant and stress loss" (1.9%), or "constant loss" (2.3%). Other variables were assessed by means of a standardized history, physical examination (including urethral axis determination and stress test), 1-week urinary diary, and postvoid residual volume measurement. A urodynamic diagnosis of pure genuine stress incontinence was used as the criterion standard. Sensitivity, specificity, and positive and negative predictive values were calculated. Logistic regression models incorporating various combinations of stress loss only, previous prolapse or incontinence surgery, nocturia, voiding frequency, urethral hypermobility, and postvoid residual volume <100 mL (the factors recommended by the Agency for Health Care Policy and Research guidelines), along with age and race as predictors of genuine stress incontinence, were constructed to evaluate the predictive ability of the guideline in a subset of 447 patients for whom data on all variables were available. RESULTS: Of the entire population 480 (50.5%) had pure genuine stress incontinence, 134 (14.1%) had both genuine stress incontinence and detrusor instability, 180 (18.9%) had pure detrusor instability, and 40 (4.2%) had intrinsic sphincter deficiency. Fifty-four (5.7%) had normal study results, and 62 (6.5%) had other nonincontinence diagnoses. Among the subjects with symptoms of stress loss only, 10.8% did not have genuine stress incontinence confirmed on urodynamic examination. Agency for Health Care Policy and Research guideline criteria had excellent discrimination (C statistic of 0.807) compared with the sole criterion of stress urinary incontinence only (C statistic of 0.574), with a positive predictive value of 85.7%. Only 7.8% of subjects met all the criteria, however, and 5.7% of these ultimately had a urodynamic diagnosis of either detrusor instability or normal study result. CONCLUSION: The predictive value of stress symptoms alone was not high enough to serve as the basis for surgical management. Agency for Health Care Policy and Research guidelines improved the predictive value but were applicable to only a small subset of patients referred with urinary incontinence.

Pelvic muscle electromyography of levator ani and external anal sphincter in nulliparous women and women with pelvic floor dysfunction.

OBJECTIVE: The purpose of this study was to compare results of electromyographic assessment of muscular recruitment between nulliparous control subjects without pelvic floor dysfunction and parous subjects with genuine stress urinary incontinence and with pelvic organ prolapse. Interference pattern analysis is an electromyographic technique that reproducibly measures muscular recruitment by detecting both "turns" in the electromyographic signal produced by positive and negative peaks of the motor unit potentials and motor unit potential amplitude. Fewer turns can indicate loss of motor units or failure of central activation of contraction, whereas greater amplitude can indicate reinnervation after nerve damage. STUDY DESIGN: We performed concentric needle electrode electromyographic examinations of the levator ani and external anal sphincter in 15 nulliparous control subjects and 20 parous subjects with abnormalities (n = 9 with genuine stress urinary incontinence, n = 11 with stage III or IV pelvic organ prolapse). We made digital recordings at multiple sites at rest and with moderate and maximal contraction. Interference pattern analysis yielded the number of turns per second and the mean signal amplitude (in microvolts) for each site at each contraction level. We compared individual patient data with data from the healthy population by means of cloud analysis. Mean values of number of turns per second and mean amplitude in each group were then compared with nonparametric methods and regression models. RESULTS: Mean ages were 28.7 years (range, 20-49 years) for the control group, 54.3 years (range, 35-75 years) for subjects with genuine stress urinary incontinence, and 65 years (range, 41-77 years) for subjects with pelvic organ prolapse. Median clinical levator ani strengths were 9 (range, 5-9) in the control group, 5 (range, 2-7) in the genuine stress urinary incontinence group, and 5 (range, 2-8) in the pelvic organ prolapse group. Median external anal sphincter strengths were 9 (range, 7-9) in the control group, 5 (range, 3-9) in the genuine stress urinary incontinence group, and 8 (range, 4-9) in the pelvic organ prolapse group. The external anal sphincters of subjects with pelvic organ prolapse had the highest percentage of abnormal study results according to cloud analysis. Mean number of turns per second in levators was greater in control subjects than in subjects with abnormalities (P =.034). We found similar differences in number of turns per second for the external anal sphincter (P =.004). In contrast, we did not find differences between groups in mean amplitude in either the levator ani or the external anal sphincter. Comparison of patients with genuine stress urinary incontinence versus subjects with pelvic organ prolapse showed no significant difference in the number of turns per second in either muscle. Mean amplitude was greater in the pelvic organ prolapse group than in the genuine stress urinary incontinence group for both muscles (levator ani, P =.028; external anal sphincter, P =.048). Neither mean amplitude nor the number of turns per second could be predicted by clinically estimated levator ani strength, age, or fecal incontinence. CONCLUSION: Compared with nulliparous control subjects, patients with genuine stress urinary incontinence and pelvic organ prolapse had changes in the levator ani and external anal sphincter consistent with either motor unit loss or failure of central activation, or both. Subjects with pelvic organ prolapse had findings consistent with greater recovery than was found in those with genuine stress urinary incontinence. Measures of recruitment by interference pattern analysis correlated better with clinical external anal sphincter strength than with levator ani strength and were independent of age.

Bilateral uterosacral ligament vaginal vault suspension with site-specific endopelvic fascia defect repair for treatment of pelvic organ prolapse.

OBJECTIVE: The anatomic and functional success of suspension of the vaginal cuff to the proximal uterosacral ligaments is described. STUDY DESIGN: Forty-six women underwent vaginal site-specific repair of endopelvic fascia defects with suspension of the vaginal cuff to the proximal uterosacral ligaments for pelvic organ prolapse. Outcome measures included operative complications, pelvic organ prolapse quantitation, and assessment of pelvic floor symptoms. RESULTS: After a median follow-up of 15.5 months (range, 3.5 months-3.4 years), 90% of patients had both resolution of vaginal bulging or prolapse symptoms and improvement of the stage of prolapse. There were improvements in all pelvic organ prolapse quantitation measurements except for total vaginal length, for which the median decrease was 0.75 cm. Intraoperatively, ureteral occlusion was noted in 11% (5/46) of patients with universal cystoscopy. In 3 patients the uterosacral suspension sutures were removed and replaced with resolution of the occlusion and in 2 patients ureteral reimplantation was required. Symptomatic prolapse (2 apical segment, 1 anterior, and 1 posterior) developed in 4 patients (10%), and 3 of them underwent reoperation. There were significant improvements in symptoms of bulging and pressure, voiding dysfunction, and vaginal and perineal splinting. CONCLUSION: Suspension of the vaginal vault to the proximal uterosacral ligaments combined with site-specific repair of endopelvic fascia defects provides excellent anatomic and functional correction of pelvic organ prolapse in most women. The risk of ureteral injury with this technique makes intraoperative cystoscopy essential.

Quantitative electromyographic analysis of levator ani and external anal sphincter muscles of nulliparous women.

OBJECTIVES: Our aims were to introduce a method of digital quantitative electromyography of the levator ani and external anal sphincter muscles and to establish reference values. STUDY DESIGN: Fifteen nulliparous, symptom-free women underwent concentric needle electromyographic examination of the levator ani and external anal sphincter. We sampled the levator ani transvaginally at 4 sites and the external anal sphincter at 2 sites. The signal was filtered and amplified, and digital recordings were made at 3 levels of voluntary activation at each site. Analyses of motor unit action potentials and interference patterns were performed with the use of these taped signals. Normal ranges were generated and compared with those established for other striated muscles. RESULTS: The mean age of the subjects was 28.7+/-7.5 years. A median of 24 motor unit action potentials was recorded in each levator ani, and a median of 6 was recorded in each external anal sphincter. Parameters of the levator ani action potentials were significantly greater than those of the external anal sphincter in amplitude (0.48 vs. 0.37 mV; P =.001), duration (10.40 vs. 8.27 ms; P =.002), number of turns per second (2. 80 vs. 2.28; P<.001), and area (0.65 vs. 0.36; P<.001). Parameters of the interference patterns were significantly greater in the levator ani than in the external anal sphincter in number of turns per second (241.6 vs. 183.9; P =.015), amplitude (302.7 vs. 225.3 microV; P<.0001), activity (95.6 vs 61.2; P =.004), envelope size (861.1 vs 567.6 microV; P<.0001), and number of small segments (105. 8 vs 81.4; P =.047). There were no significant differences between levator ani, external anal sphincter, and published parameters from the biceps muscle with regard to amplitude and duration of motor unit action potentials. CONCLUSIONS: Electromyography of the levator ani and external anal sphincter is feasible and well tolerated. Our findings confirm that the levator ani muscle has larger, more readily recruited motor units than does the external anal sphincter. Ranges for important quantitative electromyographic parameters for these muscles are similar to those published for the biceps.

Effect of patient position on clinical evaluation of pelvic organ prolapse.

OBJECTIVE: To compare the severity of pelvic organ prolapse between examinations performed in dorsal lithotomy position and examinations performed upright in a birthing chair using the Pelvic Organ Prolapse Quantification System (POPQ). METHODS: One hundred eighty-nine consecutive women were evaluated between April 1997 and September 1998. All women were examined in the dorsal lithotomy position and in a birthing chair at a 45 degrees angle. Degree of pelvic organ prolapse was assessed using the POPQ. RESULTS: When examined upright, 133 patients (70%) had the same stage of prolapse, whereas 49 (26%) had a higher stage and seven (4%) had a lower stage. Of patients who were stage 0 or I when examined in lithotomy position, 23 (36%) were stage II or greater when examined upright. Similarly, of patients who were stage II in lithotomy, 17 (23%) were stage III or higher when examined upright. There was a statistically significant increase in the degree of prolapse at all the POPQ measurements (P <.05 for each point), except for measurement of total vaginal length. Forty-eight percent of patients had at least one measurement increase by 2 cm or more when examined upright. Logistic regression identified no patient characteristics that were independently associated with a significant increase in stage or POPQ values with change in examination position. CONCLUSION: The degree of pelvic organ prolapse assessed with the patient in the lithotomy position correlates well with assessment performed upright; however, overall there is a higher degree of prolapse with upright examination.

A survey of pessary use by members of the American urogynecologic society.

OBJECTIVE: To describe trends in pessary use for pelvic organ prolapse. METHODS: An anonymous survey administered to the membership of the American Urogynecologic Society covered indications, management, and choice of pessary for specific support defects. RESULTS: The response rate was 48% (359 of 748). Two hundred fifty surveys were received at the scientific meeting and 109 were returned by mail. Seventy-seven percent used pessaries as first-line therapy for prolapse, while 12% reserved pessaries for women who were not surgical candidates. With respect to specific support defects, 89% used a pessary for anterior defects, 60% for posterior defects, 74% for apical defects, and 76% for complete procidentia. Twenty-two percent used the same pessary, usually a ring pessary, for all support defects. In the 78% who tailored the pessary to the defect, support pessaries were more common for anterior (ring) and apical defects (ring), while space-filling pessaries were more common for posterior defects (donut) and complete procidentia (Gellhorn). Less than half considered a prior hysterectomy or sexual activity contraindications for a pessary, while 64% considered hypoestrogenism a contraindication. Forty-four percent used a different pessary for women with a prior hysterectomy and 59% for women with a weak pelvic diaphragm. Ninety-two percent of physicians believed that pessaries relieve symptoms associated with pelvic organ prolapse, while 48% felt that pessaries also had therapeutic benefit in addition to relieving symptoms. CONCLUSION: While there are identifiable trends in pessary use, there is no clear consensus regarding the indications for support pessaries compared with space-filling pessaries, or the use of a single pessary for all support defects compared with tailoring the pessary to the specific defect. Randomized clinical trials are needed to define optimal pessary use.

The urethrodetrusor facilitative reflex in women: results of urethral perfusion studies.

OBJECTIVE: This study was undertaken to describe the effects of urethral perfusion on bladder activity, urethral pressure, and sensation in patients with either incontinence or prolapse or both of these. STUDY DESIGN: Among 76 consecutive patients who were seen for urodynamic evaluations, 63 had vesical, abdominal, and urethral pressures measured while the urethra was perfused with fluid. A perfusion study result was considered positive if the perfusion provoked a detrusor contraction. RESULTS: Of the 63 women 9 (14%) had a positive urethral perfusion study result, and all of them had detrusor instability independent of perfusion. Among the women with detrusor instability 53% (n = 9/17) had positive study results, versus none of the 46 women without detrusor instability (P =. 000001). Women with mixed incontinence were more likely to have a positive perfusion test result (n = 4/7; 57%) than were those without mixed incontinence (n = 5/56; 10%; P =.006), although urethral hypermobility was not significantly associated with a positive test result. Among the subjects 60% experienced urgency during perfusion, and in half of these urethral pressure was concurrently increased. Among those who had no urgency 84% demonstrated decreased urethral pressure (P =.01). CONCLUSIONS: Positive perfusion study results were more common among women with detrusor instability but did not discriminate any patient with detrusor instability whose condition was not diagnosed by standard urodynamic studies. The association of positive perfusion study results with mixed incontinence seems primarily related to poor central inhibition of detrusor activity rather than to urethral stimulation.

Observed patient compliance with a structured outpatient bladder retraining program.

OBJECTIVE: Our purpose was to determine patient compliance with a telephone-based retraining program. STUDY DESIGN: This was a retrospective study of 123 women with urinary urgency or urge incontinence who were offered bladder retraining with facsimile machine submission of a retraining diary and weekly telephone feedback. RESULTS: Completion was defined as having >/=4 follow-up sessions and >/=6 weeks of retraining. Seventy-one percent (87/123) began the retraining program; 63% (55/87) of them completed it, for an overall compliance rate of 45% (55/123). When we compared those who completed retraining with those who started but did not complete it, only concurrent use of pharmacologic therapy was significantly different (87% vs 53%, respectively; P <.001). This difference remained significant after we controlled for other independent variables, including urodynamic diagnosis and physician. CONCLUSIONS: A total of 55% of women to whom telephone-based bladder retraining was recommended either never started or were noncompliant with the treatment. Bladder retraining success in the "real world" may be substantially lower than that described in well-funded labor-intensive clinical trials.

Understanding lower urinary tract function in women soon after bladder neck surgery. Continence Program for Women Research Group.

The aim of this work was to correlate anatomic and urodynamic measures with function following bladder neck surgery. Eighty-seven women who underwent bladder neck surgery at two tertiary academic medical centers in the southeastern U.S. were studied in this prospective outcomes analysis. Preoperative and 6-week and 6-month postoperative status was assessed with urodynamic testing, physical examination, and condition-specific quality of life instruments. Correlations of dynamic urethral obstruction (quantified by pressure transmission ratio, PTR, determinations) and urethral support (quantified by urethral axis measurements) with functional status were determined. At 6 weeks, 50% of the subjects with inadequate dynamic obstruction (PTR < 90%) had genuine stress incontinence (GSI) compared to 5% of those with PTR >/= 90% (P = .00002). Of those with excessive obstruction (PTR > 110%), 32% had detrusor instability (DI) and 47% had emptying phase dysfunction (EPD) compared to 6% and 24%, respectively, of those with PTR /= 90% but

The effect of bladder training, pelvic floor muscle training, or combination training on urodynamic parameters in women with urinary incontinence. Continence Program for Women Research Group.

The purpose of this study was to compare the effect of three conservative interventions: pelvic floor muscle training, bladder training, or both, on urodynamic parameters in women with urinary incontinence. Two hundred four women with genuine stress incontinence (GSI) or detrusor instability with or without GSI (DI +/- GSI) participated in a two-site trial comparing pelvic floor muscle training, bladder training, or both. Patients were stratified based on severity of urinary incontinence, urodynamic diagnosis, and treatment site, then randomized to a treatment group. All women underwent a comprehensive standardized evaluation including multi-channel urodynamics at the initial assessment and at the end of 12 weeks of therapy. Analysis of covariance was used to detect differences among treatment groups on urodynamic parameters. Post-treatment evaluations were available for 181 women. No differences were found among treatments on the following measurements: maximum urethral closure pressure, mean urethral closure pressure, maximum Kegel urethral closure pressure, mean Kegel urethral closure pressure, functional urethral length, pressure transmission ratios, straining urethral axis, first sensation to void, maximum cystometric capacity, and the MCC minus FSV. The effect of treatment did not differ by urodynamic diagnosis. Behavioral therapy had no effect on commonly measured urodynamic parameters. The mechanism by which clinical improvement occurs remains unknown. Neurourol. Urodynam. 18:427-436, 1999.

Accuracy of clinical assessment of paravaginal defects in women with anterior vaginal wall prolapse.

OBJECTIVE: The objective of this study was to determine the accuracy of clinical assessment of paravaginal defects in women with anterior vaginal wall prolapse. STUDY DESIGN: A retrospective chart review of all women undergoing surgery for anterior vaginal wall prolapse during the years of 1994 to 1996 identified operative notes that described the surgical assessment of paravaginal support. These surgical findings were compared with the preoperative clinical assessment. Clinical parameters that predicted poor correlation were identified. Statistical analysis used the chi(2) test. RESULTS: One hundred seventeen patients had surgery for anterior vaginal prolapse. Seventy had documentation of an intraoperative paravaginal support evaluation. Of these, 44 patients had vaginal procedures, and 26 had abdominal procedures. All patients had at least stage 2 prolapse before surgery, and all were noted to have excellent pelvic support 4 to 6 weeks after surgery. The prevalence of paravaginal defects at surgery was 47% on the right and 41% on the left. The sensitivity and negative predictive value for the clinical assessment for paravaginal defects were good on both the right and left sides, whereas the specificity and positive predictive values were poor. Stage of prolapse, previous hysterectomy, or previous anterior colporrhaphy did not significantly affect the accuracy of the clinical examination in predicting fascial defects. However, previous retropubic urethropexy did significantly decrease the accuracy of the clinical examination in predicting right paravaginal defects (P <.01) but not left. CONCLUSION: Although preoperative clinical assessment for paravaginal defects is useful, it does not substitute for careful intraoperative evaluation for endopelvic fascial defects.

Reliability and correlation of measurements during and after bladder neck surgery. The Continence Program for Women Research Group.

OBJECTIVES: To assess the reliability of seven intraoperative measurements of the effects of bladder neck suspension and correlate these measurements with postoperative dynamic urethral obstruction, quantified as the cough-pressure transmission ratio. PATIENTS AND METHODS: Sixty women undergoing surgery for bladder neck hypermobility had seven measurements performed in duplicate: (i) the endoscopic appearance of the bladder neck: (ii) the bladder neck-retropubic surface distance (BN-RP distance); (iii) urethral axis; (iv) slow urethral pressure profilometry (UPP); (v) fast UPP; (vi) straining UPP; and (vii) dynamic UPP. Reliabilities were assessed by computing the intraclass correlation coefficient (R) for continuous data or Kappa statistic (K) for ordinal data. Pearson correlation coefficients were used to assess the relationships between the intra-operative measures and postoperative pressure transmission. RESULTS: The intra-operative reliabilities for maximum pressure, length and area from the three UPP techniques were high (R=0.88-0.98) as were those for urethral axis measurements (R=0.98). In contrast, reliabilities were poor for pressure transmission ratios (R=0.15-0.33), BN-RP distance (R=0.55), and endoscopic appearance (K=0.10). There were significant correlations of the pressures from the UPPs and intra-operative pressure transmission ratios with postoperative pressure transmission ratios; however, the poor intra-operative reliability of intra-operative pressure transmission limits their usefulness. None of the other measures correlated significantly with postoperative pressure transmission ratios. CONCLUSIONS: Of the measures studied, only intra-operative UPPs had both high reliability and good postoperative correlations.

Urinary incontinence and pelvic organ prolapse in nulliparous women.

OBJECTIVE: To determine differences between vaginally parous and nulliparous women presenting with urinary incontinence and pelvic organ prolapse. METHODS: Seven hundred forty eight consecutive referrals with urinary incontinence or pelvic organ prolapse, 62 of whom were nulliparous, were included in the analysis. Five hundred thirty-seven (72%) had urinary incontinence and 235 (31%) had at least stage III pelvic organ prolapse. Each subject had standard history, physical examination, and multichannel urodynamic testing. Differences between parous and nulliparous women were compared using parametric and nonparametric analysis of variance and the chi2 test with Yates correction where appropriate. RESULTS: The only significant demographic difference between the groups was that parous women had more previous continence and prolapse surgery. There were significant differences in distribution of diagnoses according to parity, with the nulliparas much less likely to have pelvic organ prolapse. Among incontinent women without prolapse, nulliparas were significantly more likely to have pure detrusor instability. Of those with pure genuine stress incontinence, nulliparas were older, had less anterior vaginal wall descent, less bladder neck mobility, narrower genital hiatus and perineal body measurements, and lower maximum urethral closure pressures. Of those with pure detrusor instability, the only difference was that nulliparas were significantly younger. For women with stage III pelvic organ prolapse or worse, no significant difference in any measured characteristic was noted. CONCLUSION: Nulliparous women were less likely to present with pelvic organ prolapse and those with urinary incontinence differed little from incontinent parous women.

An anatomic and functional assessment of the discrete defect rectocele repair.

OBJECTIVE: The aim of this study was to describe the anatomic and functional results of the discrete fascial defect rectocele repair. STUDY DESIGN: Sixty-nine women underwent rectocele repair at Duke University Medical Center during a 3-year period beginning January 1, 1994. Repair was limited to reapproximation of discrete defects in the rectovaginal fascia, without levator plication or perineorrhaphy. Outcome measures included Pelvic Organ Prolapse Quantitation measurements, prolapse stage, and a symptom questionnaire. Univariate and nonparametric tests were used as appropriate. RESULTS: Before the operation 46% patients (32/69) reported constipation, 39% (27/69) reported splinting, 32% (22/69) reported tenesmus, and 13% (9/69) reported fecal incontinence. The median preoperative posterior Pelvic Organ Prolapse Quantitation stage was 2 (1-4). Pelvic Organ Prolapse Quantitation stage had improved for all but 2 women at 6 weeks. Eighteen percent (8/43) had recurrent rectoceles at 12 months. Mean values for the points describing the posterior vaginal wall improved >2 cm (P <.0001). Although perineorrhaphy was not performed, the genital hiatus decreased by 2. 3 cm (P <.0001), with no significant change in the length of the perineal body. Functional results mirrored anatomic results, with statistically significant improvements for all symptoms. CONCLUSIONS: The discrete defect rectocele repair provides anatomic correction of rectoceles with alleviation of associated symptoms for most women.

Comparative efficacy of behavioral interventions in the management of female urinary incontinence. Continence Program for Women Research Group.

OBJECTIVE: We compared the efficacy of bladder training, pelvic muscle exercise with biofeedback-assisted instruction, and combination therapy, on urinary incontinence in women. The primary hypothesis was that combination therapy would be the most effective in reducing incontinent episodes. STUDY DESIGN: A randomized clinical trial with three treatment groups was conducted in gynecologic practices at two university medical centers. Two hundred and four women diagnosed with genuine stress incontinence (n = 145) and/or detrusor instability (n = 59) received a 12-week intervention program (6 weekly office visits and 6 weeks of mail/telephone contact) with immediate and 3-month follow-up. Outcome variables included number of incontinent episodes, quality of life, perceived improvement, and satisfaction. Data analyses consisted of analysis of covariance using baseline values as covariates and chi2 tests. RESULTS: The combination therapy group had significantly fewer incontinent episodes, better quality of life, and greater treatment satisfaction immediately after treatment. No differences among groups were observed 3 months later. Women with genuine stress incontinence had greater improvement in life impact, and those with detrusor instability had less symptom distress at the immediate follow-up; otherwise, no differences were noted by diagnosis, incontinence severity, or treatment site. CONCLUSIONS: Combination therapy had the greatest immediate efficacy in the management of female urinary incontinence regardless of urodynamic diagnosis. However, each of the 3 interventions had similar effects 3 months after treatment. Results suggest that the specific treatment may not be as important as having a structured intervention program with education, counseling, and frequent patient contact.