A new external urethral occlusive device for female urinary incontinence.

OBJECTIVE: Determine the efficacy of a new external anti-incontinence urethral device. METHODS: A before-after 1 month trial, open longitudinal study of 155 women complaining of urinary incontinence recruited from a referral urogynecology practice and local media advertising was performed. Primary outcomes included assessing the efficacy of the device using visual analogue scales, quality-of-life questionnaires, 1- and 48-hour standardized pad tests, and voiding diary. Secondary outcomes consisted of the evaluation of the adverse effects and the clinical profile of patients willing to use the device after study completion. RESULTS: Ninety-six (62%) of 155 women enrolled completed the study. Scores on the visual analogue scales improved for the symptoms of stress incontinence, urgency, and urge incontinence (P < .001). The score for irritation/discomfort increased (P < .001). Data from diaries showed that 38 (44%, n = 86) patients were dry. Of 454 recorded patient-days, 325 (72%) were dry days. On pad testing, incontinence was cured in 49% (1-hour pad test, n = 59, P < .001) and 44% (48-hour pad test, n = 32, P < .001) of patients. Quality-of-life scores were significantly improved in 48% (n = 96, Incontinence Impact Questionnaire, P < .001) and 32% (n = 96, Urogenital Distress Inventory, P < .001) of patients. There was no increase in bacteriuria. After study completion, 61 (39%) women chose to continue using the device, but this was not predictable from baseline data. CONCLUSION: Use of this device resulted in a significant reduction in incontinence and improvement in quality-of-life issues with minimal adverse events in the majority of women. This new anti-incontinence device could become a useful addition to the armamentarium of nonsurgical options.

Dry mouth with conventional and controlled-release oxybutynin in urinary incontinence. The Ditropan XL Study Group.

OBJECTIVE: To compare the efficacy and safety of controlled-release oxybutynin with conventional, immediate-release oxybutynin and determine rates of dry mouth. METHODS: Patients (n = 226) who were known to be responsive to anticholinergic therapy and who had seven or more urge incontinence episodes per week were randomized to receive controlled-release oxybutynin or immediate-release oxybutynin. After an initial placebo run-in period, dosing in each began at 5 mg per day and increased weekly by 5 mg per day to a maximum of 20 mg per day or when a balance between improvement of incontinence symptoms and tolerability of side effects was achieved. Rates of urge incontinence and dry mouth were compared. Post hoc Kaplan-Meier survival analysis was used to describe elimination of incontinence episodes by dose and to analyze dry mouth risk by dose. RESULTS: Reductions in urge urinary incontinence episodes from baseline to the end of treatment were 18.6 to 2.9 per week (83% mean decrease) and 19.8 to 4.4 per week (76% mean decrease) in the controlled- and immediate-release oxybutynin groups (P =.36), respectively. At equal doses, comparable proportions of patients in both groups reported the absence of urge incontinence (P =.85). The incidence of dry mouth increased with dose in both groups, but there was no difference in dry mouth rates between the groups: 47.7% and 59.1% for the controlled- and immediate-release oxybutynin (P =.09), respectively. However, Kaplan-Meier analysis to examine first report of dry mouth at a given dose revealed that a significantly lower proportion of patients taking controlled-release oxybutynin had moderate to severe dry mouth (P =.007) or any dry mouth (P =.003) compared with those taking immediate-release oxybutynin. CONCLUSION: At the same daily dose, controlled- and immediate-release oxybutynin demonstrated comparable efficacy in reduction of urge incontinence episodes. The incidence of dry mouth was dose dependent but equal in both groups; first report of moderate to severe dry mouth was significantly lower in the controlled-release group.

Skin collagen changes in postmenopausal women receiving different regimens of estrogen therapy.

Collagen is a widespread body constituent that is affected by estrogen status in women. Its decrease after menopause can be prevented and/or restored by estrogen treatment. We explored the effect of four different hormonal replacement regimens on total skin collagen content by measuring hydroxyproline in skin biopsy specimens taken from postmenopausal women. All regimens showed increases in skin collagen levels proportionate to the levels at the start of the treatment. Estrogen replacement therapy is shown to be prophylactic in women who have higher skin collagen levels and both prophylactic and therapeutic in women with lower skin collagen levels.

Videourodynamic diagnosis of occult genuine stress incontinence in patients with anterior vaginal wall relaxation.

OBJECTIVE: To (1) utilize videourodynamics, the gold standard, to assess the prevalence of occult genuine stress incontinence (GSI) among preoperative patients with symptomatic anterior vaginal wall relaxation and (2) identify urodynamic discriminators that might help predict occult GSI. METHODS: In this prospective study, videourodynamic evaluation was performed on 48 consecutive patients presenting for preoperative urodynamic evaluation of anterior vaginal wall prolapse. Patients with occult GSI were identified by urodynamic testing with and without Gehrung pessary support of the bladder base during stress maneuvers. Variables from the history, physical examination, and videourodynamics were then analyzed. RESULTS: The overall incidence of occult GSI was 25% (22.7% in the pelvic organ prolapse [POP] group and 26.9% in the POP-UI group). Patients with occult GSI were not identifiable on history but did have a higher incidence of late first sensation, open bladder neck at rest, and hypermobility on imaging with videourodynamics. CONCLUSION: This study suggests that one quarter of women presenting with anterior wall relaxation with or without incontinence symptoms have occult GSI. Given this high prevalence, preoperative evaluation with urodynamics, possibly videourodynamics, utilizing bladder base support is justified if the data are substantiated in a larger, definitive study. Patients with a late first sensation, open bladder neck, and hypermobility may have a higher incidence of occult GSI.

Skin collagen changes in post-menopausal women receiving oestradiol gel.

Sixteen post-menopausal women who had never previously received any hormonal treatment applied Oestrogel cream 1.5 mg/day percutaneously for 1 yr. Skin biopsies were taken from the abdomen and from the lateral aspect of the thigh at 0, 3, 6 and 12 mth, and the changes in skin collagen content were noted. The abdominal skin collagen content increased significantly (P less than 0.001) over the 1-yr treatment period. The thigh skin collagen content also increased, but did not reach significant levels. There was a strong correlation between the change in skin collagen content (in both the abdomen and the thigh) and the original skin collagen content, indicating that the change in collagen content in response to oestrogen therapy is dependent on the original level. There is no further increase once an 'optimum' skin collagen level has been reached.

Physiotherapy for stress urinary incontinence: a national survey.

OBJECTIVE: To study the physiotherapeutic treatment of urinary stress incontinence in England. DESIGN: Postal questionnaire survey. SETTING: All 192 English district health authorities. SUBJECTS: One physiotherapist from each district who was primarily concerned with urinary incontinence. A consensus view was requested. MAIN OUTCOME MEASURES: Responses to questionnaire and analysis of a visual analogue scale to indicate effectiveness. RESULTS: There was a 98% response rate. Treatment was often by senior physiotherapists (108 senior I grade or above) who, in 117 districts, claimed to have made a specialty of treating the condition. Gynaecologists and obstetricians were far more likely to refer patients than any other agency (147 respondents said that they were the commonest source of referral). One hundred and fifty four respondents stated that physiotherapy was usually used as the first line of treatment. Pelvic floor exercises and interferential treatment were most commonly used (by 178 and 144 respondents respectively) and thought to be the most effective, especially in combination, though various techniques were used in applying them. Positive motivation (108), recent onset of symptoms (55), and youth (40) were viewed optimistically, and obesity (60), previous surgery (59), prolapse (42), and a chronic cough (36) were considered to be bad prognostic features. The number of patients treated varied greatly (range 10-360) between districts and was poorly correlated with catchment size (correlation coefficient 0.3). CONCLUSIONS: As physiotherapists are treating considerable numbers of patients with stress incontinence research is urgently needed to produce efficacy data to enable rationalisation of resources to cater for the whole population.

The significance of an open bladder neck in women.

The significance of an open bladder neck at rest has been investigated in 147 women presenting to a urodynamic clinic. The prevalence of this condition was 21%; there was an association with urethral sphincter incompetence but an open bladder neck was not diagnostic of it. It is suggested that the finding of an open bladder neck at rest during urodynamic investigation is of little consequence.

Discriminant analysis of urethral pressure profilometry data for the diagnosis of genuine stress incontinence.

Urethral pressure profilometry (UPP) has been advocated for the diagnosis of genuine stress incontinence (GSI) but no published data exist to define clearly the criteria of measurement that should be used. The aim of this study was to examine the value of UPP in the diagnosis of GSI. Data from 102 urodynamically normal women and 70 women with GSI were compared. Thirty UPP variables from the resting and stress profiles were examined. The urodynamic diagnosis was made on the basis of a pad test, uroflowmetry and videocystourethrography. Each UPP variable was examined singly and thereafter all the measurements were examined by discriminate analysis. The single most discriminatory UPP variable was 'area under the stress profile' but the overlap between normal and GSI patients was too great to allow the test to be used diagnostically. Discriminate analysis resulted in correct classification in 78% of cases. On the basis of these results, UPP is not an accurate test for the diagnosis of GSI.

Efficacy of an external urethral device in women with genuine stress urinary incontinence.

The efficacy of a new external anti-incontinence device in patients with a videourodynamic diagnosis of genuine stress incontinence (GSI) in an open longitudinal study is reported. Fourteen women with GSI underwent assessment before and after 3-4 weeks of device use. Assessment consisted of visual analog scores (VAS), quality of life (QOL) questionnaires, urine for culture and a 1 hour pad test. VAS scores showed a significant improvement for the symptom of stress incontinence (P<0.05). QOL scores improved significantly by 38% (P<0.05) and 29% (P<0.01) for the Incontinence Impact Questionnaire and Urogenital Distress Inventory, respectively. The mean pad weight decreased by 47% (P=0.056). Of the 9 women who had a positive pad test (>2 g) without the device, 5 were dry (<2 g) with the device (P<0.05). These preliminary data suggest that this device is effective in women with GSI.

Predictive value of clinical evaluation of stress urinary incontinence: a summary of the published literature.

Our objective was to evaluate the symptom and sign of stress incontinence in predicting the presence of urodynamically diagnosed genuine stress incontinence (GSI). The study was a computation of the sensitivity and predictive values from the published literature (1975-1998), evaluating the history and/or physical examination for the diagnosis of GSI, with calculation of efficacy variables. Results show that the isolated symptom of stress incontinence has a positive predictive value (PPV) of 56% for the diagnosis of pure GSI and 79% for GSI with additional abnormalities. The PPV of stress incontinence in association with other symptoms is 77% in detecting GSI (with or without additional abnormalities). A positive cough stress test has a PPV of 55% for detecting pure GSI and 91% for the mixed condition (GSI plus additional diagnosis). When isolated, the symptom or the sign of stress incontinence is a poor predictor of GSI. In combination, the prediction may be more promising.

Urethral function.

Our understanding of the pathophysiological mechanisms of the urethra is still limited but improving. The valsalva leak point pressure measurement has been proposed as a simple and reproducible technique for the evaluation of urethral resistance, and progress has been made in the elucidation of urethral closure pressure generation that may lead to effective pharmacological therapy for treatment of functional obstruction. Magnetic resonance imaging is the newest technique for providing detailed anatomical information on the urethra and peri-urethral tissues.

Perineal pad weighing versus videographic analysis in genuine stress incontinence.

A comparison was made of the sensitivity of perineal pad testing and the videographic diagnosis of genuine stress incontinence (GSI) in postmenopausal women. The 99% upper confidence limit for pad weight gains in 90 normal women was 1.4 g. Ninety-nine women with urodynamically proven GSI were studied and 14 had false negative pad tests. There was no significant correlation between the videographic assessment and the gain in pad weight. We recommend the use of the pad test to confirm incontinence only in the absence of imaging facilities as the latter is more sensitive.

Prolonged pregnancy.

The perceived risks to the fetus of the postmature syndrome have led to the obstetrician's dilemma of whether to await spontaneous parturition or to artificially bring forward the onset of labor to an arbitrarily defined gestation. A prolonged or post-term pregnancy relates to a gestation of greater than 42 weeks and should not be regarded as synonymous with postmaturity. The latter describes a clinical syndrome thought to be a consequence of failing placental function. It is the difficulty in identifying the 'at risk' fetus which has led to routine induction policies. But is such a policy justified in terms of fetal outcome, and if so, is the mother put at increased risk? This review puts into perspective the most recent publications and points out areas requiring further study.

A comparison of 25 mg and 50 mg oestradiol implants in the control of climacteric symptoms following hysterectomy and bilateral salpingo-oophorectomy.

OBJECTIVES: 1. To compare the effects of 25 mg and 50 mg oestradiol implants on serum follicle stimulating hormone and oestradiol levels; and 2. to assess the relationship of the dose of oestradiol implant and serum oestradiol on the effectiveness and duration of climacteric symptom control. DESIGN: Randomised, double-blind investigation. PARTICIPANTS: Forty-four women, who had undergone total abdominal hysterectomy and bilateral salpingo-oophorectomy. METHODS: The women were randomised to receive either 25 mg (n = 20) or 50 mg (n = 24) oestradiol implants. Follow up consisted of prospective symptom enquiry and hormone assays. MAIN OUTCOME MEASURES: Primary: climacteric symptom control: duration and effectiveness; secondary: serum oestradiol and follicle stimulating hormone levels. RESULTS: Serum oestradiol was significantly higher and serum follicle stimulating hormone significantly lower after the fourth month of treatment in women receiving 50 mg implants. No significant difference in symptom control was noted in the two groups. The mean duration of symptom control was similar in the two groups: 5.9 months (SD 2.4) in those receiving 50 mg oestradiol and 5.6 months (SD 2.3) in those receiving 25 mg. CONCLUSION: The higher level, 50 mg oestradiol implants does not result in better control of symptoms nor in longer periods of symptom control compared with 25 mg oestradiol implants. In order to maximise compliance, 25 mg oestradiol implants should therefore be the treatment of choice for women with normal bone density seeking relief of climacteric symptoms.

Symptoms analysis for the diagnosis of genuine stress incontinence.

OBJECTIVE: To determine the accuracy of an analysis of symptoms alone for the diagnosis of genuine stress incontinence. DESIGN: A comparison of results of symptoms analysis with urodynamic findings. SETTING: A gynaecological video-urodynamic unit. SUBJECTS: 252 consecutive patients referred for urodynamic investigations. INTERVENTIONS: A questionnaire of 20 symptoms of lower urinary tract dysfunction, midstream specimen of urine, pad testing, uroflowmetry, and video-cystourethrography. MAIN OUTCOME MEASURES: Using the urodynamic diagnosis as the 'gold standard', the accuracy of discriminant function analysis of symptoms was determined. RESULTS: Symptoms analysis achieved a correct classification of 81% with a false positive rate of 16%. Use of an accumulative probability curve defines patients who fall into the equivocal range. CONCLUSIONS: All women presenting with incontinence should undergo preoperative urodynamic studies.

Urethral pressures: analysis of transmission pressure ratios.

Transmission pressure ratio (TPR) analysis of urethral pressure profilometry data has been advocated for the diagnosis of genuine stress incontinence (GSI). However, the clinical usefulness of the technique has not been adequately evaluated. Using videourodynamics as the gold standard, the TPR results of 150 continent women and 153 with GSI have been compared. The mean TPR for each quartile of the functional urethral length was computed, as was the maximum TPR value (TPR-max) and the position on the urethra where it occurred (TPR-mode). There was a statistically significant difference between the 2 groups for TPR values in the distal 2 quartiles of the urethra and for TPR-max and TPR-mode. With the use of the Kappa statistic it was found that the TPR-mode was the most discriminatory of the TPR parameters. Even using this measure, the overlap between normal and GSI was so great as to make accurate diagnosis impossible. It was therefore concluded that TPR analysis is useless for the diagnosis of GSI. However, such an analysis is helpful for the understanding of the pathophysiology of GSI and its treatment.

The impact on health-related quality of life of stress, urge and mixed urinary incontinence.

OBJECTIVE: To examine the impact of each type of urinary incontinence (stress, urge, and mixed) on health-related quality of life (HRQL). SUBJECTS AND METHODS: The USA National Overactive Bladder Evaluation (NOBLE) programme of prevalence was used to identify respondents with incontinence based upon telephone survey responses. A nested case-control study was then conducted on respondents with symptoms of an overactive bladder (OAB), and on age and gender-matched controls; this consisted of the respondents completing a series of questionnaires, including the OAB-q (an HRQL scale for OAB), the Medical Outcomes Study (MOS) Short-Form-36 (SF-36), the MOS Sleep Scale, and the Center for Epidemiological Studies - Depression (CES-D) scale. Respondents were categorized into subgroups according to the primary cause of urine loss, i.e. sudden/uncomfortable urge to urinate (urge, UI), physical pressure (stress, SI), or both (mixed, MI). Descriptive analyses, t-tests and analysis of variance with post hoc comparisons were used. RESULTS: Of the 919 participants in the nested case-control study, 171 reported incontinence, i.e. UI (69), SI (62) and MI (40). Among this cohort, 82.5% were female, 85.4% were Caucasian and the population had a mean age of 55.9 years. All OAB-q subscale scores were significantly (P < 0.01) worse among those with MI than with SI. Respondents with UI reported significantly higher levels of symptom bother and lower sleep scores (both P < 0.001) than those with SI. There were no differences in HRQL between the MI and UI groups. Voiding frequency and nocturia episodes did not differ among the groups but compared with the SI group, both UI and MI groups reported significantly higher ratings of urinary urge intensity (P < 0.001) and rated their need for medical care significantly higher (P < 0.01). The MI group reported more incontinence episodes (P = 0.02) than the SI group. CONCLUSION: Compared with SI, respondents with UI and MI reported not only significantly greater ratings of urinary urge intensity and more incontinence episodes, but also significantly worse HRQL. These results are consistent with previous findings which indicated a greater impact on HRQL for the urge component of MI than for the stress component.