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PubMed1999

Calculating the direct costs of urinary incontinence: a new test instrument.

OBJECTIVES: To develop a universally applicable test instrument to measure the total direct costs of urinary incontinence, including personal costs and treatment costs, i.e. the Dowell-Bryant Incontinence Cost Index (DBICI), and to study the construct validity and test-retest reliability of the instrument. PATIENTS AND METHODS: In a prospective observational study, 100 consecutive community-dwelling ambulatory women who presented with stress, urge or mixed incontinence were asked to complete the DBICI questionnaire on two occasions, 7 days apart, before any treatment. The construct validity of the DBICI was ascertained by correlation with other standard measures of urinary incontinence severity; (i) a visual analogue scale (VAS) to assess the impact of leakage upon lifestyle; (ii) frequency-volume charts (voids/24 h, leaks/week); (iii) urine loss during a standard 1 h pad test; and (iv) two disease-specific quality of life questionnaires. The test-retest reliability was measured by comparing the two test results and the construct validity of the individual subsets (personal and treatment) of the DBICI similarly assessed. RESULTS: Ninety-seven women completed the baseline assessment and 84 completed the re-test. The median (interquartile range) total direct incontinence cost (in Au$) was 12. 89 (5.26-22.67) per week, which comprised the median personal costs of 5.61 (1.68-10.36) and the median treatment costs of 4.96 (1.22-13. 37). The total direct incontinence cost was significantly correlated with the severity of urinary leakage on a 1 h pad test (Kendall's rank correlation, P=0.01), with the VAS impact score (P<0.001) and with the number of leaks/week (P=0.005). The correlation between the personal cost subset and other quantitative measures was also highly significant. Test-retest analysis of the personal costs subset revealed that this subset was robust and satisfied the statistical criteria of repeatability. CONCLUSIONS: The DBICI gives a detailed measure of the direct economic costs of urinary incontinence in ambulatory home-dwelling women, with the construct validity confirmed by the significant correlation with other quantitative measures of incontinence. By substituting local prices into the test format, the index should be useful in other countries. In the current climate of economic rationalization, such an index should be a part of future urinary incontinence research.

Adult↗
PubMed2002

Long-term assessment of the incontinence ring pessary for the treatment of stress incontinence.

A prospective cohort of 38 women who presented with predominantly stress incontinence symptoms were fitted with an incontinence ring pessary. They had documented stress incontinence on multichannel urodynamic testing. Nine women (24%) were not leaking by subjective measures. Six women (16%) continued using the pessary. This group of women had no statistically identifiable parameters that distinguished them from women who had not wanted to continue using the pessary. There was a trend showing that successfully fitted women were younger (41 vs 52 years old), had less pelvic surgery and leaked less on semiquantitative pad testing (10.7 g vs 19.2 g). In women who chose to continue using the pessary there was a trend showing a decrease in the semiquantitative pad score (1.2 g from 10.7 g) and 7-day voiding diary (1.5 episodes from 4.1). In conclusion, the incontinence pessary was successful in a small proportion of women with stress incontinence.

Adult↗
PubMed2006

SPARC sling system for treatment of female stress urinary incontinence in the elderly.

OBJECTIVE: To investigate the safety and efficacy of the suprapubic arch (SPARC) sling procedure for the management of stress urinary incontinence (SUI) in elderly women. METHOD: Forty-three women, aged 65-91 yr, underwent the SPARC procedure for urodynamic SUI. Before surgery, a complete medical history was obtained and a urogynecology examination and urodynamic test were performed. The objective cure rate was evaluated by clinical and urodynamic examination at 3, 6, and 12 mo and the subjective cure rate was assessed using a visual analogue score and a global patient impression questionnaire. RESULTS: No severe intraoperative or postoperative complications occurred. No patient referred de novo urge incontinence. Significant differences were found between the preoperative and postoperative number of daytime voidings (p < 0.001), the pad weights and numbers of pads used (p < 0.001), and the visual analogue score (p = 0.021). No significant differences in preoperative and postoperative urodynamic parameters were reported. At the mean follow-up of 36+/-14 mo (range, 12-54 mo), objective and subjective cure rates were 91% and 95%, respectively. CONCLUSIONS: The SPARC procedure is effective and offers a satisfactory cure rate without significant morbidity in elderly women with SUI.

Aged↗
PubMed1997

Patient-reported impotence and incontinence after nerve-sparing radical prostatectomy.

BACKGROUND: The age-adjusted rate of radical prostatectomy, the most common treatment of early (nonmetastatic) prostate cancer, increased almost sixfold between 1984 and 1990. This increase was due in part to reported improvements in postoperative sexual potency after the use of newly developed "nerve-sparing" procedures. However, published estimates from physicians of impotence following various types of radical prostatectomy may be low, since not all patients may report treatment-related complications accurately and completely to their doctors. In contrast, direct surveys of patients indicate much higher rates of postoperative sexual and urinary dysfunction. One problem with most physician and patient surveys is that they have been performed retrospectively, and pretreatment impotence and incontinence prevalent in older men cannot be assessed accurately in retrospective studies. PURPOSE: This study was initiated in a cohort of men before they underwent radical prostatectomy to assess treatment-related effects on impotence and incontinence. METHODS: The study population consisted of 94 men enrolled in a cohort study of treatment for early prostate cancer. The patients completed questionnaires about sexual and urinary functions before surgery and at 3 and 12 months after surgery and had adequate information to assess the type of surgical technique used (non-nerve-sparing, unilateral nerve-sparing, or bilateral nerve-sparing). Because items assessing sexual function were inadvertently omitted from the questionnaire in the initial months of the study, information on sexual function for all time periods was available for only 49 men. RESULTS: Compared with men who had not been treated with a nerve-sparing procedure, men who underwent nerve-sparing radical prostatectomy, particularly of the bilateral type, were younger and had better prognostic features, indicating less advanced cancers. Before surgery, nine (75%) of 12 men not treated with a nerve-sparing procedure reported erections that were usually inadequate for sexual intercourse compared with six (33%) of 18 men and one (5%) of 19 men who underwent unilateral and bilateral nerve-sparing prostatectomies, respectively. At 12 months after surgery, most men reported inadequate erections, including 15 (79%) of the 19 men who had bilateral nerve-sparing surgery; unilateral nerve preservation provided no apparent benefit. In general, nerve-sparing surgery was associated with more use of absorbent pads at 3 and 12 months following treatment, and this approach was associated with substantial urinary incontinence at 3 months but not at 12 months following surgery. CONCLUSIONS: Nerve-sparing prostatectomy, particularly when performed unilaterally, improves postoperative sexual function to a lesser extent than previously reported. Because men with preoperative impotence and more advanced cancers receive nerve-sparing surgery less often, some of the previously reported benefit of nerve preservation may be the result of patient selection and not of the technique per se.

Aged↗
PubMed2004

Efficacy and morbidity of autologous fascia lata sling cystourethropexy.

PURPOSE: Sling cystourethropexy for intrinsic sphincter deficiency has more recently been accepted as effective surgical treatment for all types of stress urinary incontinence. We report our experience using autologous fascia lata for sling cystourethropexy, regarding treatment efficacy, harvest site morbidity and patient satisfaction. MATERIALS AND METHODS: A retrospective data base review identified all women who underwent sling cystourethropexy using autologous fascia lata for stress urinary incontinence. A followup survey study using questionnaires (Black and Urogenic Distress Inventory-6) combined with questions regarding pad use, satisfaction and leg morbidity was done. RESULTS: A total of 100 women who could be contacted and who had undergone autologous fascia lata sling cystourethropexy performed by a single surgeon between 1993 and 2002 were surveyed. Mean patient followup was 4.4 years (range 0.8 to 9.3). Of the women 85% stated that they were dry or improved and 93% were pain-free at the harvest site by 7 days. There was no harvest site infection and no lower extremity thrombotic complication. Of the patients 83% indicated that the procedure had a positive effect on their life with only 4% stating that it had a negative effect, while 77% were satisfied with the procedure, 82% would recommend the procedure to a friend with incontinence and 83% would undergo the procedure if making the decision again. CONCLUSIONS: Autologous fascia lata sling cystourethropexy is associated with high patient satisfaction and treatment efficacy comparable to that of other sling cystourethropexy materials, as determined by questionnaire. Harvest site morbidity is low. Sling cystourethropexy using autologous fascia lata should be considered as a primary surgical approach in women with stress urinary incontinence.

Fascia Lata↗
PubMed2002

Clinical effects of preoperative radiation therapy on anorectal function after proctectomy and colonic J-pouch-anal anastomosis.

PURPOSE: Preoperative radiotherapy is increasingly used for certain rectal cancers, although some evidence suggests that it may adversely affect anorectal function. Reconstruction with a colonic J-pouch-anal anastomosis after complete proctectomy is thought to improve function, but few published data on pouch function after radiation exists. The aim of our study was to compare long-term bowel habits in patients receiving preoperative radiation for rectal cancer followed by colonic J-pouch-anal anastomosis with those of patients having similar rectal cancer surgery without radiation. METHODS: Patients (n = 125) having undergone colonic J-pouch-anal anastomosis for rectal cancer, of whom 28 had preoperative radiotherapy and 97 did not, responded to a detailed questionnaire about their bowel habits at least 12 months after surgery, with a mean (+/- standard deviation) interval of 64 (+/-42) months. Radiation was administered preoperatively as a short (25 Gy over 5 days, n = 22) or long (45 Gy over 4 weeks, n = 6) course. All patients had colonic J-pouch-anal anastomosis with manual anastomosis at or immediately above the dentate line. RESULTS: Except for tumor stage, no preoperative difference was observed between the two groups. The number of bowel movements per 24 hours in patients with and without radiation was 1.8 (+/-0.8) and 1.8 (+/-1.5), respectively (P> 0.05). In the irradiated group, diarrhea (39 vs.13 percent, P= 0.005) and nocturnal defecation (36 vs.15 percent, P= 0.03) were more frequent than in the nonirradiated group. No other significant difference existed between groups with regard to stool clustering, use of protective pads, ability to defer evacuation >15 minutes, ability to evacuate the bowel within 30 minutes, incontinence score, use of medications, or dietary restriction. CONCLUSION: Preoperative radiotherapy followed by proctectomy and colonic J-pouch-anal anastomosis significantly increased nocturnal defecation frequency and diarrhea compared with similar nonirradiated patients but had no influence on the other bowel-habit parameters studied.

Aged↗
PubMed2002

[Functional and urodynamic characteristics in patients with ileal neobladder].

We analyzed the functional and urodynamic characteristics in 19 patients with ileal neobladder by the Hautmann procedure. A questionnaire survey by mail was performed for functional information of neobladder. Seventeen of the 19 patients (89.5%) could voluntarily void via the urethra and the others needed clean intermittent self catheterization (CIC) because of their significant residual volume. Eight of the 19 patients (42.1%) micturated at least two times at night. Two of the 19 patients (10.5%) were incontinent in the day time and 12 (63.2%) in the night time. They needed 2 pads in the day time and one pad at night on average. Eight out of 18 patients (44.4%) were satisfied with their micturition state. A urodynamic study showed the neobladder to be a low-pressure reservoir with a mean capacity of 395.2 +/- 96.8 ml. The mean residual volume of the patients without CIC was 27.8 +/- 28.2 ml. In 10 out of 11 patients high frequency and high amplitude spikes were seen by the perineal electromyogram in the voiding phase.

Adult↗
PubMed2004

Prospective trial of gasless laparoscopic Burch colposuspension using conventional surgical instruments.

STUDY OBJECTIVE: To prospectively evaluate the use of gasless laparoscopy techniques in the performance of a traditional Burch colposuspension in women with urodynamically-demonstrated genuine stress incontinence and urethral hypermobility. DESIGN: Multicenter, prospective, single-intervention series (Canadian Task Force Classification II-2). SETTING: Three urogynecologic referral centers. PATIENTS: Fifty-eight women. INTERVENTION: Traditional Burch colposuspension performed utilizing gasless laparoscopic access and conventional surgical instruments. MEASUREMENTS AND MAIN RESULTS: Follow-up was 12 to 38 months. On pad testing, urine loss was significantly reduced, from 6.0 g (CI: 0.55-11.45) to 0.3 g (CI: 0-1.53). Average daily incontinence episodes based on 7-day voiding diaries decreased from 4.7 (CI: 0.87-8.53) to 0.3 (CI: 0-1.58). Q-tip angles were normalized: 49.8 degrees (CI: 40.86-58.74) to 10 degrees (CI: 1.49-18.51). Ninety-five percent of subjects reported resolution of stress incontinence. Three subjects (5%) reported recurrent/persistent genuine stress incontinence: one was operated on during the postpartum period while breastfeeding, and two developed intrinsic sphincteric deficiency postoperatively. Fifty-five percent of subjects underwent other pelvic reconstructive surgery including posterior wall repairs. Average operative time was 60.8 minutes (range, 40-92). The ideal candidate has an unscarred abdominal wall. CONCLUSION: Gasless laparoscopic access was used to effectively perform traditional Burch colposuspension using conventional open surgical instruments. Bladder neck hypermobility was normalized in all subjects, and 95% of subjects reported no further stress incontinence.

Adult↗
PubMedDate not supplied

Pelvic floor muscle training with biofeedback and bladder training in elderly women: a feasibility study.

OBJECTIVE: It is generally assumed that interventions used to treat urinary incontinence (UI) in young women could simply be applied to older competent and motivated women, but these assumptions have not been formally tested. The purpose of this study was to determine the feasibility of using physical therapies to treat UI in older women. DESIGN: Twelve-week time series. SETTINGS AND SUBJECTS: We recruited women older than 75 years with UI from an outpatient urology clinic and a waiting list for incontinence surgery. METHODS: After a baseline evaluation, the women collected data on their incontinence symptoms and bladder habits for 3 weeks using the 72-hour voiding diary and the 24-hour pad test. They then received 6 physical therapy treatments consisting of a combination of bladder training and pelvic floor muscle training assisted with biofeedback for 6 weeks. This was followed by another 3-week period of data collection and a final evaluation. RESULTS: Ten women participated in the study; 7 completed it. They were all comfortable with the treatment. They complied with the study demands in terms of attendance at treatment session (100%), data collection (96%), and completion of exercises at home (82%). The authors observed a decrease in the number of incontinent and urgency episodes. CONCLUSION: This preliminary study demonstrates that some women older than 75 years are good candidates to undertake physical therapies for UI and follow study demands. Random controlled studies that include this population will provide evidence regarding the effectiveness of these therapies.

Age Factors↗
PubMed2000

Update on extracorporeal magnetic innervation (EXMI) therapy for stress urinary incontinence.

Pulsed magnetic technology has been developed for pelvic floor muscle strengthening for the treatment of urinary incontinence. This report includes an update of the prospective multicenter study of extracorporeal magnetic innervation (ExMI) therapy for stress incontinence and a discussion of the possible mechanisms of action. Issues of patient selection for ExMI therapy will also be discussed. One hundred and eleven women with demonstrable stress urinary incontinence were studied. The mean age was 55 +/- 13 years, and the mean duration of symptoms was 11 years. Ninety-seven completed ExMI therapy and analysis. Evaluation before treatment included bladder diaries, dynamic pad weight test, urodynamics, and a quality-of-life survey. For treatment the patients were seated fully clothed in a Neocontrol chair with a magnetic field therapy head in the seat. Treatment sessions were for 20 minutes, twice a week, for 6 weeks. After ExMI therapy, all of the measures were repeated at 8 weeks, including the dynamic pad weight testing and quality-of-life survey. At 6 months, further data were added, including repeat bladder diary, pad use, and quality-of-life survey. Forty-seven women completed 6 months of follow-up; of the 47, 13 patients were completely dry (28%) and 25 used no pad or less than 1 pad per day (53%). Pad use was reduced in 33 patients (70%). The median number of pads was reduced from 2.16 to 1 per day (Wilcoxon signed rank test, P <0.005). The frequency of leak episodes was reduced from 3.0 to 1.7 at 6 months (Wilcoxon signed rank test, P = 0.004). Detrusor instability was demonstrated in 10 before and 6 after ExMI (P <0.05). ExMI offers an alternative approach for the treatment of urinary incontinence. ExMI therapy is effective for both stress and urge incontinence. The best results are achieved in those patients who use no more than 3 pads a day and have had no prior continence surgery.

Adult↗
PubMed1997

Use of a vaginal sponge during aerobic exercises in patients with stress urinary incontinence.

A newly marketed vaginal sponge intended to support the urethra was tested during aerobic exercise in a group of 6 women suffering from stress urinary incontinence. The patients performed half an hour of aerobic exercises on 2 consecutive days, with and without the vaginal sponge. A pad was worn during exercise and weighed before and after. Without the vaginal sponge the patients had a mean loss of 7 g (range 2-18 g) during exercise. With the vaginal sponge in situ there was no leakage. The sponge can be recommended for use during sports in patients with mild to moderate incontinence.

Adult↗
PubMed2006

A new postoperative predictor of time to urinary continence after laparoscopic radical prostatectomy: the urine loss ratio.

OBJECTIVES: To assess the correlation of a newly defined parameter, "urine loss ratio" (ULR), with the time to continence and probability for incontinence after laparoscopic radical prostatectomy (LRP). MATERIALS AND METHODS: A standardized "micturition protocol" that uses 24-h pad testing to objectively quantify urine loss after removal of the catheter was obtained from 939 patients who underwent LRP and were provided complete follow-up regarding continence. ULR was defined as the weight of urine loss in the pad divided by daily micturition volume, distinguishing between ULR on the first day after catheter removal and the last day of hospital stay. The time to continence was classified as early (0-3 mo), midterm (4-12 mo), and late continence (13-24 mo). RESULTS: Early continence was attained in 69.8% (n=655) of patients, midterm continence in 18.4% (n=173), and late continence in 3.5% (n=33). Of 939 patients in whom first-day ULR was quantified, 495 patients were not discharged immediately and their last-day ULR was quantified (2.3 d following catheter removal). There was a linear correlation between time to continence and ULR, which was more significant for last- than first-day ULR (p<0.001). A cutoff point of more than 15% of urine loss indicates a high risk of incontinence (ie, 8-fold for first-day ULR, 55-fold for last-day ULR). CONCLUSION: ULR predicts the time to continence and may be used to select patients for specific rehabilitation programs and early adjuvant medical therapy, particularly when urine loss exceeds 15%.

Adult↗
PubMed2006

Analysis of risk factors associated with surgical failure of inside-out transobturator vaginal tape for treating urodynamic stress incontinence.

The goals of this study were to assess the efficacy of inside-out transobturator vaginal tape (TVT-O) as a treatment of urodynamic stress incontinence (USI) and to explore the possible factors determining surgical success and failure. Each woman had a 20-min pad test and urodynamic study including uroflowmetry, cystometry, and stress urethral pressure profile before and after treatment. Forty-six of the 54 women (85%) were cured of the disease, and two (4%) showed clinical improvement; TVT-O had failed to treat USI in six patients (11%) during the 9-month follow-up period. We assessed the relationship between clinical features, urodynamic parameters, and treatment outcome. Of these, only age and previous anti-incontinence surgery were significant risk factors for surgical failure. The success rate during the 9-month follow-up period decreased significantly in women > or =60 years and in women with previous anti-incontinence surgery. Women with USI can be treated by the TVT-O procedure.

Adult↗
PubMed1997

Vaginal electrostimulation for the treatment of genuine stress incontinence.

The value of vaginal electrostimulation for genuine stress incontinence was evaluated in 30 women with this condition. Subjective and objective measurements were made before and after 3 and 15 months of treatment using urinary diaries, perineometry and pad tests. After 3 months use, 21 women (70%) reported a subjective improvement, but this had fallen to 9 (30%) by 15 months. There were significant reductions in the numbers of daily incontinent episodes and pad/pant changes and significant increases in the perineometry readings at both 3 and 15 months. There were no side-effects observed with electrostimulator use, but 1 patient withdrew due to a dislike of the method of treatment. Vaginal electrostimulation would seem to be a simple and well tolerated means of managing genuine stress incontinence in a selected group of women.

Adult↗
PubMed1996

Assessing and Managing Urinary Incontinence in Primary Care.

Incontinence generally results from a problem either with the urethra or with the bladder. The urethra can permit urine to leak when it moves incessantly due to poor support or when it closes poorly, as can occur with a neurologic disorder. In the bladder, hyperactivity due to involuntary contractions, or low compliance, can lead to urinary incontinence. A thorough history and physical examination guide management. The history should elicit information that can allow the clinician to assess how severe the problem is (eg, number of pads used per day, frequency of leakage) and factors that may cause or influence the problem, such as medications used, previous surgical and obstetric history, and urologic history including prior therapy for incontinence. Information about when leakage is at its worst is useful. Leakage that worsens in winter is typically associated with detrusor instability. Leakage that worsens at night can indicate a problem with bladder compliance. Incontinence that started after the onset of an antihypertensive or antipsychotic medication may be due to alpha-receptor antagonist effects of drugs such as prazosin or chlorpromazine. Difficulty emptying the bladder may be associated with medications that block cholinergic and calcium-channel activity, such as sedatives, antidepressants, antispasmodics, antiemetics, antipsychotics, antiarrhythmics, and anticonvulsants. Mild incontinence can be managed conservatively in a primary care setting, with pelvic-floor exercise, behavior therapy, or anticholinergic therapy. Patients with severe incontinence or an unclear etiology of incontinence should be referred to a specialist for urodynamic testing.

Journal Article↗
PubMed2006

Comparison of bone-anchored male sling and collagen implant for the treatment of male incontinence.

AIM: To compare the effectiveness of transurethral collagen injection and perineal bone-anchored male sling for the treatment of male stress urinary incontinence (SUI). METHODS: Seventy-one men with SUI underwent either transurethral collagen injections (n = 34) or perineal bone-anchored male sling (n = 37) between June 1999 and October 2003. Most of the patients in each group had radical retropubic prostatectomy and/or external beam radiation therapy (EBRT) in relation to the cause of incontinence. There was one patient in both groups who only had EBRT for the cause. The mean duration of incontinence were 4.2 and 4.4 years, respectively. Collagen injections were carried out transurethrally either under regional or general anesthesia until co-aptation of mucosa was observed. The male sling was placed under spinal anesthesia with a bone drill using either absorbable or synthetic materials. Retrospectively, all patients were assessed for continence status and procedure-related morbidity, if present. The outcome of both procedures was also compared with the degree of incontinence. RESULTS: Ten (30%) patients in the collagen group showed either significant improvement or were cured following injections. Preoperatively, the mean pad use in collagen group was 4.5 (SD 2.8) per day, whereas it was 2.2 (SD 1.1) after the injection(s). Collagen injection failed in 24 (70%) of the patients. Patients who received the male sling had a mean preoperative pad use of 3.7 (SD 1.5) and postoperatively, the number decreased to 1.6 (SD 1.2). Most of the patients in this group were either totally dry or significantly improved (n: 28, 76%). There was a statistically significant difference between two groups in respect to success rate (P < 0.05). Analysis of treatment outcome with the degree of incontinence revealed that the male sling is most effective in patients with minimal-to-moderate incontinence. CONCLUSIONS: Our results suggest that the male sling, a minimally invasive procedure, is more effective than collagen implant in the treatment of mild-to-moderate SUI in men.

Adult↗
PubMed2006

Bowel dysfunction in patients with cauda equina lesions.

Despite their serious sequels on bowel function, lesions of the cauda equina have not been previously systematically studied in larger patient populations. This was the aim of the present report. From the registrars of a diagnostic and rehabilitation centres 67 patients with clinical, electrodiagnostic and radiological findings supportive of the cauda equina lesions were recruited. The Slovene versions of the standard questionnaires for anal incontinence and constipation were used. The responses were scored, impairments categorized and previous treatments noted. Neurological examination, electromyography (EMG) of lumbo-sacral myotomes, quantitative anal sphincter EMG and electromyographic evaluation of the sacral reflex were performed. Severe anal incontinence/constipation was reported by 18%/0%, moderate by 36%/33%, and slight by 28%/43% of our patients. Twenty-one per cent of patients wore pads continuously and 14% occasionally. More than half of the patients (60%) reported changes in their lifestyle due to anal incontinence. No patient had completely normal findings on neurological examination. Perianal sensory loss correlated (P < 0.05) with anal incontinence and gender with constipation (women > men). Only two patients had received medical attention for bowel dysfunction. Study thus demonstrated significant bowel impairment in patients with lesions of the cauda equina, which has received insufficient medical attention.

Adult↗
PubMed1999

An open study of the bladder neck support prosthesis in genuine stress incontinence.

OBJECTIVE: To determine the proportion of unselected women with genuine stress incontinence in whom a bladder neck support prosthesis could be fitted successfully by three gynaecologists with no prior knowledge of the device, and to measure efficacy of the device. DESIGN: Prospective interventional study. SETTING: Two metropolitan urodynamic units. SAMPLE: Eighty women with genuine stress incontinence. MAIN OUTCOME MEASURES: Average number of leaks per day on a frequency volume chart, average number of pads worn per day, urine loss on a one-hour pad test, and urine flow rate. RESULTS: Of the 80 recruits, 11 had exclusion criteria and four could not be fitted at the first visit. Of 65 participants, 39 (58%) withdrew from the study before week four. In 20 of 39 women (51%) post-surgical scarring made fitting difficult, and six (15%) withdrew for unrelated personal or medical reasons. In five women (13%) the device was never effective; six withdrew because of adverse events and two required devices that were larger or smaller than those presently available. Thus 38 of 65 participants (58%) could be fitted by the three gynaecologists. Of 26 women who wore the device for four weeks, median leaks per day fell from 2.5 (interquartile range (IQR) 1.9-4.6) to 1.0 (IQR 0-2); median number of pads per day fell from 1.5 (IQR 0.5-3) to 0 (IQR 0-1); and median pad test loss fell from 19 g/h (IQR 8-49) to 2 g/h (IQR 0-8). Sixteen of these 26 patients (62%) achieved objective success, six (23%) were socially continent, one failed to respond and three declined to complete all outcome measures. Urine flow rates revealed no evidence of outflow obstruction. At the sixth month, 18 of 26 patients (69%) were wearing the device successfully; 15 of these women continued to the 12th month, and all but one were objectively dry. CONCLUSIONS: The bladder neck support prosthesis is a useful addition to the range of treatments available for the management of genuine stress incontinence, but may be difficult to fit in women who are oestrogen-deprived or have undergone multiple surgical procedures. The demands of the trial protocol were found to be onerous by frail elderly women.

Aged↗