Factors which influence the short-term success of pessary management of pelvic organ prolapse.

OBJECTIVE: The purpose of this study was to identify patient criteria which may affect the outcome of a pessary trial. STUDY DESIGN: Records of 407 patients presenting with symptomatic pelvic organ prolapse who had a trial of pessary management were reviewed. Success was defined both by the initial fitting as well as by whether the patient was using the pessary at the 3-week follow-up visit. Outcomes were compared using chi-square test, 2-sample Student t test, or the Wilcoxon rank sum test, as appropriate. Statistical analysis was carried out at a significance of .05. RESULTS: One hundred sixty-eight patients (41%) were successfully fitted and continuing to use a pessary at the time of the 3-week follow-up visit. The likelihood of a successful pessary trial was significantly lower in subjects with a past history of hysterectomy (P<.001) or known reconstructive surgery for prolapse (P=.010). There was no association between the stage of prolapse and pessary trial outcome. There was no significance found in the relationship between the predominant location of support loss and the pessary trial outcome at the 3-week follow-up visit. CONCLUSION: The type and severity of pelvic organ prolapse do not influence the likelihood of a successful pessary fitting, and should not be used as a basis on which to select patients for pessary management.

Current perception threshold evaluation of the female urethra.

The purpose of this study was to determine the feasibility of the current perception threshold (CPT) evaluation in the female urethra. Women without LUT dysfunction underwent CPT testing using a Neurometer (Neurotron, Inc., Baltimore, MD) connected to a ring electrode in the urethra. Testing was done in a standardized fashion at three frequencies, 2000, 250 and 5 Hz, to determine when subjects first perceived the stimuli and when perceived stimuli became painful. Current perception threshold testing was accomplished in all 10 subjects studied. The level at which subjects first perceived stimuli was significantly lower than that at which the stimuli became painful ( P<0.002). Mean perception thresholds at 2000, 250 and 5 Hz were 70 microA (range 14-230), 25 microA (4-80) and 17 microA (2-78), respectively, and mean pain thresholds were 229 microA (54-424), 91 microA (24-162) and 110 microA (25-200), respectively. There was no difference in subjects' perception thresholds at 250 and 5 Hz ( P=0.206). Perception thresholds and pain thresholds were significantly different at all other frequencies. Women without LUT dysfunction have lower perception thresholds than pain thresholds and can distinguish between most stimuli at different frequencies. Current perception threshold testing of the female urethra is technically feasible and may be useful for assessing the functional integrity of different afferent pathways.

Validation of a clinical algorithm to diagnose stress urinary incontinence for large studies.

PURPOSE: We assessed the accuracy with which a clinical diagnostic algorithm for stress urinary incontinence (SUI) based on symptoms and signs without including urodynamics predicted the observation of urodynamic SUI and the condition of SUI. Such an algorithm would have applicability to ensure that the majority of women entering large SUI clinical trials would have urodynamic SUI and/or the condition of SUI without performing urodynamic testing in all subjects. MATERIALS AND METHODS: A total of 1455 women with urinary incontinence at least 3 months in duration were enrolled in 3 randomized clinical trials (1 phase 2 and 2 phase 3 trials) of duloxetine vs placebo for the treatment of SUI in Europe and North America. Subjects were identified as having SUI based on a clinical algorithm that required a predominant symptom of SUI with a weekly incontinence episode frequency of 4 or greater (phase 2 study), or 7 or greater (phase 3 studies), absent predominant urge symptoms, normal diurnal and nocturnal frequency, a bladder capacity of 400 ml or greater, and a positive cough stress (sign of SUI) and stress pad test. Multichannel urodynamic studies were performed in a subset of 184 women at 23 study sites. Of these urodynamic tracings 173 (94%) were of adequate quality to make an assessment of the filling phase and assign a diagnosis of urodynamic SUI, detrusor overactivity or a normal filling phase. Two-sided 95% exact CIs for the proportions were calculated. RESULTS: The clinical algorithm had a positive predictive value of 90.2% for urodynamic SUI with or without detrusor overactivity and 76.9% for urodynamic SUI only (pure urodynamic SUI). The positive predictive value for the condition of pure SUI was 85.0%, while for the condition of SUI in pure and mixed forms the positive predictive value was 98.3%. Patient age, previous continence surgery or the severity of incontinence did not influence algorithm accuracy. CONCLUSIONS: The algorithm is suitably feasible and sufficiently predictive to be used in large clinical trials designed to evaluate conservative treatment for women with SUI. It ensures that the overwhelming majority of the study population would have urodynamic SUI and the condition of SUI.

Bladder-anal reflex.

AIMS: The purposes of this study were to evaluate the bladder-anal reflex (BAR) latency in asymptomatic women and determine the pathway of the reflex using selective anesthesia and neuromuscular block. METHODS: Urinary incontinence, voiding dysfunction, and pelvic organ prolapse are common problems in women. Evaluation of pelvic nerve function often augments the clinical assessment of these women. Urethral-anal and clitoral-anal reflex testing have been reported as methodologies to assess patients with neurogenic disorders. A bladder-anal reflex is also obtainable but has not been reported previously in the literature. Twenty-two subjects and two patients were recruited for evaluation of the BAR. RESULTS: This study has allowed us to estimate reference ranges for BAR latency and threshold. We defined the upper limit of these reference ranges as two standard deviations above their respective means. For the BAR latency, the upper limit of the reference range is 91 msec. Any latency value above this limit should be considered abnormal. The upper limit for the BAR threshold reference range is 37.7 mA. Lower thresholds are not thought to be clinically meaningful due to the presence of several low sensory thresholds in this asymptomatic normal population. CONCLUSIONS: The BAR was obtainable in asymptomatic women and compatible with known anatomy and innervation of the lower urinary tract.