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Evaluation of the subjective and objective effect of maximal electrical stimulation in patients complaining of urge incontinence.

BACKGROUND: Favorable results have been reported following Maximal Electrical Stimulation (MES) of patients with urgency and urge incontinence. However, patient groups have often been mixed and outcome measures poorly defined. We therefore wanted to treat a homogeneous patient population with MES and evaluate the effect by defined subjective and objective outcome measures. METHODS: Eighteen female patients complaining of urge incontinence had MES performed. Before and 3 months after MES, the patients performed a 24 hour micturition chart and pad test. They indicated on a visual analogue scale their subjective degree of urgency and leakage and had an ambulatory urodynamic monitoring performed. Nine months after MES the patients were asked whether their urge incontinence was less, equal or more troublesome than before MES. RESULTS: After MES the patients indicated significantly less urgency and leakage. A significant difference was not found in any of the objective outcome measures after MES. Six out of 18 patients (33%) found their urge incontinence less troublesome 9 months after MES, while 12 (66%) found it unchanged or more troublesome than before. CONCLUSIONS: Significantly subjective effect was found following MES. However, none of the objective outcome measures were significantly improved. We were disappointed by the results and have stopped using the method.

Adult↗

Does detubularization improve continence in bladder replacement?

Camey in the seventies promoted bladder replacement. In 1987, the French Association of Urology gave us the opportunity to review 729 Tubularized Ileocystoplasty (Camey operation) [1]. The day time continence was excellent or acceptable (mild stress incontinence) on 91% of the patients, the night time continence was excellent (no pads, no leakage) or acceptable (one pad or less than 3 wakes at night) for 44% of the patients (56% had to use a device). Since 1985, the detubularization attempted to improve the continence rate. Today, the review of the literature shows that day time continence has not changed and the night time continence improved less than 20% arising from 44% to 60%. Bladder replacement after prostatocystectomy has been proved to be superior to continent urinary diversion in patients whose urethral and external sphincter can be preserved. Day time continence is excellent in tubularized and detubularized bowel reservoirs. Night time continence, in 30 to 50% of patients, remains an unresolved problem also in detubularized low pressure reservoirs, even if they are of great capacity. The literature is therefore too optimistic when describing night time continence in 85% of the patients. These results are stated in spite of the absence of sensitivity in the neobladder, the loss of reflexic increase in sphincteric activity during bladder filling, and the low sphincteric tonus during sleeping. These optimistic results are due to lack of unanimous criteria for evaluating continence after bladder replacement and not taking into consideration as continence failure the abundant although not frequent nighttime incontinence. In order to improve continence, muscle reeducation and artificial sphincter implantation are the most adequate solutions.(ABSTRACT TRUNCATED AT 250 WORDS)

Humans↗

Sacral neuromodulation for the treatment of refractory urinary urge incontinence after stress incontinence surgery.

OBJECTIVE: This study was undertaken to evaluate the response to sacral neuromodulation in women with refractory, nonobstructive urinary urge incontinence after stress incontinence surgery. STUDY DESIGN: We reviewed the medical records of women in whom sacral neuromodulation was performed for worsening or de novo urinary urge incontinence after a stress incontinence procedure. All patients had undergone preliminary test stimulation. Demographics, surgical and urogynecologic history, including bladder diary and pad weight test, and urodynamic parameters were evaluated. RESULTS: Of 34 women, 22 (65%) responded to the test stimulation and underwent permanent lead implant. There was no difference between responders and nonresponders with respect to type of stress incontinence surgery. Incontinence or urodynamic parameters were not different between responders and nonresponders. Factors that were predictive of a positive response were women aged less than 55 years (P = .01), the test stimulation performed within 4 years of the stress incontinence procedure (P = .01), and evidence of pelvic floor muscle activity (P = .03). CONCLUSION: Sacral neuromodulation is a viable option for the treatment of refractory urinary urge incontinence that occurs after stress urinary incontinence surgery. Older women with no pelvic floor activity who are remote from their incontinence surgery may have a suboptimal response.

Electric Stimulation Therapy↗

Pelvic floor electrical stimulation in the treatment of stress incontinence: an investigational study and a placebo controlled double-blind trial.

PURPOSE: We designed an investigational study and a placebo controlled, double-blind study to evaluate the usefulness of electrical pelvic stimulation in stress incontinence. MATERIALS AND METHODS: We studied 44 patients with stress incontinence (six men and 38 women, age 63 +/- 13), including 9 patients in the investigational study and 35 in the double-blind study. We used 50 Hz. square waves of 1 ms. pulse duration for stimulation. A vaginal electrode was used in women and an anal electrode in men. Urethral pressure profile before, during and after 15-minute stimulation was measured in the investigational study. In the double-blind trial an active device and a dummy device were used, and efficacy was judged from patient impressions, records in frequency/volume chart, results of 1-hour pad test and urodynamic parameters after 4-week treatment. RESULTS: In the investigational study maximum urethral closure pressure (mean plus or minus standard deviation) before, during and after stimulation was 44.4 +/- 17.5, 64.5 +/- 28.8 and 46.8 +/- 25.6 cm. water, respectively. This parameter significantly increased (p = 0.0275) during stimulation. In the double-blind trial patient impressions were good in 60% of the active device group and 8% of the dummy device group (p = 0.0051). For the pad test significant improvement was noted in the active device group (p = 0.0100). Cure rate was 45% in the active device group and 7.7% in the dummy device group. There were significantly more cured or improved patients for frequency of leakage (p = 0.0196) and pad test (p = 0.0100). CONCLUSIONS: Electrical stimulation is effective for the treatment of stress incontinence.

Aged↗

An assessment of the early surgical outcome and urodynamic effects of the tension-free vaginal tape (TVT).

Fifty-two women underwent a tension-free vaginal tape (TVT) procedure for genuine stress incontinence (GSI). Preoperative assessment included a detailed medical history, pelvic examination, a 1-hour pad test with a comfortably full bladder, and urinary culture. Thirteen of the 52 women were excluded for various reasons. Both before and 12-24 months postoperatively all patients had a full urodynamic investigation using microtip transducer catheters. The study subjects were instructed to maintain a 1-week baseline urinary diary 1 week before the operation, and postoperative urodynamic assessment as well. The period of follow-up ranged from 12 to 24 months (median 19 months). Another 1-hour pad test with a comfortably full bladder and urinary culture were carried out thereafter. Comparisons of the 39 women pre- and postoperatively found a significantly improved 1-hour pad test (34.9 +/- 34.7 vs 8.3 +/- 24.0, P<0.001). Analyzing the urodynamic effects of surgery revealed no significant postoperative changes except for the maximal urethral closure pressure (MUCP) at rest. An objective assessment using a pad test revealed the success rate (cure plus improved) to be 90% (35/39) and the failure rate 10% (4/ 39). TVT can thus be considered a safe and effective procedure for GSI in women. Moreover, the urodynamic effects of surgery were not found to be critical to success.

Adult↗

A new double-layered launderable bed sheet for patients with urinary incontinence.

In a skilled nursing facility, 36 patients (chiefly elderly) with persistent urinary incontinence were the subjects of this study. In their management, the usual disposable pads were compared with a new launderable bed sheet (Kylie) which absorbs urine in the second layer while maintaining a dry surface next to the patient's skin. There was a 42 percent reduction in the frequency of bedding changes with the new bed sheets. The patients experienced increased comfort due to decreased skin wetness and decreased creasing of the sheets. The reduced frequency of bed linen changes permitted longer undisturbed periods for the patient. Management costs were reduced by 40 percent with the launderable bed sheets. There were no adverse effects on the condition of the patients or in the quality of care.

Adult↗

The male bulbourethral sling procedure for post-radical prostatectomy incontinence.

PURPOSE: We evaluate the efficacy of the male bulbourethral sling procedure in the treatment of post-radical prostatectomy urinary incontinence. MATERIALS AND METHODS: We reviewed the records of 64 consecutive men with severe post-prostatectomy incontinence who underwent the male bulbourethral sling procedure at Northwestern Memorial Hospital and Stanford University Hospital. Preoperatively 50% of the patients were completely incontinent (diapers, clamps or condom catheter), and the remainder required a mean of 4.7 pads per day. Data were collected by chart review, patient interviews at followup appointments and telephone interviews. Median followup was 18.1 months (mean 22.4, range 6.5 to 53.8). RESULTS: Following a single sling procedure 36 patients (56%) became dry, and 5 (8%) were significantly improved. In 17 patients 23 retightening procedures were performed, which decreased the median followup to 16 months and increased the success rate to 75% (67% cured, 8% improved). The revision, erosion and infection rates were 27, 6 and 3%, respectively. CONCLUSIONS: The male bulbourethral sling procedure is effective treatment for post-radical prostatectomy urinary incontinence. Patients who had received adjuvant radiation therapy demonstrated a lower continence rate than those who had not. Further followup is needed to assess long-term efficacy.

Aged↗

Timed voiding for the management of urinary incontinence in adults.

BACKGROUND: Timed voiding is a fixed time interval toileting assistance program that has been promoted for the management of people with urinary incontinence who cannot participate in independent toileting. For this reason, it is commonly assumed to represent current practice in residential aged care settings. OBJECTIVES: To assess the effects of timed voiding for the management of urinary incontinence in adults who cannot participate in independent toileting. SEARCH STRATEGY: We searched the Cochrane Incontinence Group specialised register (9 May 2002), MEDLINE (January 1966 to December 2002), EMBASE (January 1980 to Week 18 2002), CINAHL (January 1982 to February 2001), PsycINFO (January 1972 to current), Biological Abstracts (January 1980 to December 2000), Current Contents (January 1993 to December 2001) and the reference lists of relevant articles. We also contacted experts in the field, searched relevant websites and handsearched journals and conference proceedings. SELECTION CRITERIA: We selected all randomised and quasi-randomised trials that addressed timed voiding in an adult population and that had an alteration in continence status as a primary outcome. We included those trials that had assessed timed voiding delivered either alone or in combination with another intervention and compared it with either usual care, or no timed voiding, or another intervention. DATA COLLECTION AND ANALYSIS: Data extraction and quality assessment were undertaken by at least two people working independently of each other. Any differences were resolved by discussion until agreement was reached. The relative risk for dichotomous data were calculated with 95% confidence intervals. Where data were insufficient to support a quantitative analysis, a narrative overview was undertaken. MAIN RESULTS: Two trials with a total of 298 participants met the inclusion criteria. Both compared timed voiding plus additional intervention with usual care. In one of these timed voiding was combined with continence products, placement of a bedside commode for each participant, education to staff on transfer techniques, feedback and encouragement to staff, praise to participants for "successful responses" and administration of oxybutynin in small doses. The mean percentage who were incontinent when checked daily was 20% in the intervention group compared with 80% in the control group. No further between group analysis was possible from the data reported. The other trial combined timed voiding with a medical assessment and individualised medical management that was based on clinical data. Reduction in the number of participants with daytime and night-time incontinence was greater in the intervention group but this difference was statistically significant only for night-time wetting. There was no difference in the volume of urine lost as determined by pad weighing. The methodological quality of these trials was not high based on the quality appraisal criteria of the Cochrane Incontinence Group. In particular, there was a lack of clarity regarding levels of blinding. It was not possible to combine data from trials. In both trials, the fixed schedule of toileting was combined with other interventions. The extent to which the results reflect the contribution of timed voiding is unknown because the trials' design did not allow assessment of the effects of the fixed schedule of toileting separately from other components of the interventions. REVIEWER'S CONCLUSIONS: The data were too few and of insufficient quality to provide empirical support for or against the intervention of timed voiding.

Adult↗

Urinary incontinence after radical prostatectomy: implications and urodynamics.

OBJECTIVES: The purpose of this study was to evaluate urine loss, quality of life, and urodynamics in men who had urinary incontinence after radical prostatectomy and who were at least 12 months post surgery. SUBJECTS AND METHODS: Men from a previous study (N = 180) regarding quality of life and treatment of incontinence post prostatectomy were solicited. Twenty-one men were still incontinent 2 or more years post surgery; 16 agreed to further evaluation. The latter patients completed a 24-hour pad test, frequency/volume chart, quality-of-life questionnaire, and underwent video urodynamics. RESULTS: Median time from surgery was 22 months (14 to 33 months) and the mean urine loss over 24 hours was 164 g. Incontinence had an impact on quality of life, but men adjusted their lives and most would undergo radical prostatectomy again. Half of the subjects experiencing stress urinary incontinence on urodynamics also had a component of detrusor dysfunction (urge incontinence/decreased compliance). CONCLUSIONS: Quality of life was significantly affected by urinary incontinence, but most subjects would undergo radical prostatectomy again. Symptoms of stress urinary incontinence alone may not reflect the urodynamic diagnosis. Detrusor dysfunction should be considered in the etiology of incontinence after radical prostatectomy.

Aged↗

Prospective patient-reported continence after laparoscopic radical prostatectomy.

OBJECTIVES: To perform a prospective study using confidential patient-completed questionnaires about their urinary habits before and after laparoscopic radical prostatectomy. Published reports on urinary continence after radical prostatectomy vary depending on the definitions of urinary continence and methods of data collection. METHODS: From May 1998 to February 2000, 228 men underwent laparoscopic radical prostatectomy for clinically localized prostate cancer. The patients were given questionnaires before surgery and at 1, 3, 6, and 12 months postoperatively. RESULTS: Before surgery, no patient reported incontinence. At 1, 3, 6, and 12 months postoperatively, perfect diurnal urinary control (no pads, no leakage at all) was reported in 9.9%, 28.6%, 57.4%, and 56.8% of patients, respectively. No pads were used in 18.8%, 58.4%, 68.9%, and 78.4% at 1, 3, 6, and 12 months, respectively. No patient reported use of more than 1 pad daily at 6 months of follow-up. CONCLUSIONS: Continence after laparoscopic radical prostatectomy is comparable to the results after traditional radical retropubic prostatectomy. Ongoing use of the laparoscopic route for treating clinically localized prostate cancer is warranted.

Aged↗

Surgical reconstruction for complete urinary incontinence: a 10 to 22-year followup.

A 22-year followup study was performed on 27 children and 7 adults treated surgically for complete urinary incontinence. The etiology of the incontinence was iatrogenic, traumatic or congenital. The patients had undergone a urethral reconstruction that created a physiological sphincter by ureteral reimplantation and trigonal tubularization. Success was defined if a patient was dry with no leakage or stress urinary incontinence and partial success was noted if the patient wore 1 to 3 perineal pads per day that were moist to damp. Of 7 adults 4 (57 per cent) were dry and 2 (29 per cent) were considered a partial success, compared to 19 (70 per cent) and 1 (3 per cent), respectively, of 27 children. Postoperatively, no significant residual urine was present and the excretory urograms were normal. Failures and alternative treatments for failures are discussed.

Adult↗

Randomized clinical trial comparing suprapubic arch sling (SPARC) and tension-free vaginal tape (TVT): one-year results.

PURPOSE: Suprapubic Arch sling (SPARC) has been initially presented as being comparable to Tension-free Vaginal Tape (TVT) without published trials. To test the safety and efficacy of this new product, we designed a prospective, randomized clinical trial with a minimum follow-up of 1 year. MATERIALS AND METHODS: 84 women presenting with Stress Urinary Incontinence (SUI) were randomly assigned to SPARC or TVT as a minimally invasive mid-urethral sling procedure. All patients were re-evaluated at 1, 6, and 12 months. Symptom assessment, Incontinence Impact Questionnaire (IIQ), physical examination, Uro-Dynamic Studies (UDS) and 1-hour pad test were repeated at 1-year follow-up. RESULTS: 41 patients were randomized to SPARC and 43 to TVT. The two groups had similar baseline characteristics. Both procedures resulted in similar peri-operative complications: bladder perforation (24% vs. 23%), median estimated blood loss (0-50 ml), median hospital stay (1-night), post-operative analgesia, and persistent urinary retention necessitating tape resection (2 patients in each group). There were three other complications in the SPARC group: tape erosion, infected pelvic hematoma, and urinary tract infection. At 12 months, there was no statistically significant difference between SPARC and TVT, in terms of objective cure rates as determined by 1-hour pad test of less than two grams (83% vs. 95%; p< or =0.1; 12% difference, 95% CI: 25.4% to -1.4%) and subjective cure rates as determined by IIQ scores (49.9+/-25.6 vs. 45.3+/-18.4; p=0.46). CONCLUSIONS: At 1-year follow-up, there is no statistically significant difference between SPARC and TVT. Longer follow-up is needed to confirm these results.

Aged↗

Long-term results of the bulbourethral sling procedure.

PURPOSE: We evaluated the long-term efficacy of the male bulbourethral sling procedure in the treatment of post-radical prostatectomy urinary incontinence. MATERIALS AND METHODS: Between October 1994 and June 2000, 95 patients with post-radical prostatectomy incontinence underwent bulbourethral sling placement with tetrafluoroethylene bolsters at our hospital. Ultimately 71 of these patients responded to our questionnaire and they were classified into 2 groups. Group 1 consisted of 62 patients who had not undergone prior radiation therapy and group 2 consisted of 9 who had undergone radiation therapy before the sling procedure. Patients were asked to respond to questions regarding continence status as well as the validated Incontinence Quality of Life and International Prostate Symptom Score questionnaires. RESULTS: Mean followup from the most recent sling procedure was 4 years (range 0.27 to 6.55). Average patient age at questionnaire response was 74 years. A total of 86 procedures were performed on 71 patients. Of the 71 patients 7 underwent either sling removal or artificial urinary sphincter placement and were excluded from questionnaire analysis. Including retightening procedures 68% of the patients (72% of group 1, 43% of group 2) required 2 or less pads daily. Of the patients 36% (42% of group 1 and 14% of group 2) required 0 pads. CONCLUSIONS: The male bulbourethral sling procedure remains an effective treatment for post-prostatectomy incontinence at 4-year followup.

Aged↗

Can we afford to take short cuts in the management of stress urinary incontinence?

Is urodynamics necessary in the management of female stress urinary incontinence? This has remained a point of contention among urologists and gynaecologists alike. In this prospective study we evaluated 28 patients urodynamically to assess our diagnostic accuracy and to audit our intended management. These patients had complained solely or predominantly of stress incontinence. None of them had previous abdominal or vaginal surgery for stress urinary incontinence or a history suggestive of voiding disorder. All 28 of them were listed for either a Burch colposuspension or Stamey endoscopic bladder neck suspension operation based on demonstrating the sign stress incontinence clinically or radiologically on screening cystography. In all these cases the diagnosis of genuine stress incontinence was presumed and urodynamics would not have been performed preoperatively, if not for this study. As a result, there was a 21% overall change in the intended management. Routine but simplified urodynamics (to include pad test, provocative cystometry, uroflowmetry and residual urine measurement) would appear to be a pre-requisite of genuine stress incontinence surgery, even in patients complaining solely of stress incontinence.

Adult↗

An evaluation of a new pattern of electrical stimulation as a treatment for urinary stress incontinence: a randomized, double-blind, controlled trial.

OBJECTIVE: To evaluate a new pattern of electrical of electrical stimulation as a treatment for stress incontinence. DESIGN: A randomized, double-blind, controlled trial. SETTING: The study took place on three clinical sites. SUBJECTS: Patients (n = 27) with urodynamically proven stress incontinence recruited via consultant referral. INTERVENTIONS: Patients were randomly allocated to one of two groups: the new pattern of stimulation or sham stimulation. MAIN OUTCOME MEASURES: Patients were assessed pre, mid and post treatment using: perineometry, digital assessment and pad testing. The following were only used pre and post treatment: seven-day frequency/volume chart, SF-36, the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. RESULTS: No significant between-group differences were highlighted except when quality of life was assessed with the Urogenital Distress Inventory (p = 0.01). A significant reduction in scores was observed in the stimulation group (p = 0.03) However, improvements were seen in both the strength and endurance characteristics of the pelvic floor musculature, although these changes were not translated into a reduction in symptoms. CONCLUSION: Although promising, the improvement in pelvic floor function did not result in a reduction in symptoms in all patients. Further research is required to investigate the effects of the new stimulation in combination with pelvic floor exercises and to compare the new stimulation pattern with existing forms of electrical stimulation.

Double-Blind Method↗

Effect of vaginal devices on bladder neck mobility in stress incontinent women.

OBJECTIVE: To evaluate how vaginal continence products affect the bladder neck mobility and ability to contract the pelvic floor muscles. MATERIAL AND METHODS: Fifteen stress incontinent women with leakage >8 g/24 hours were assessed by a questionnaire, 24 hours pad test and vaginal ultrasonography of bladder neck position and mobility. The patients were examined without any device, with a commercially available device (Conveen Continence Guard, CCG, Coloplast A/S) and two new shaped test models (TM I/II). Bladder neck position was measured in relation to the midline of the pubic symphysis at rest, Valsalva and squeezing. RESULTS: About two-thirds of the women became subjectively continent with the device. The mean leakage per 24 hours was reduced 87% (61-96%) with a vaginal device. No difference was found between the effect of old and new product. Evaluated by ultrasonography, the devices worked by supporting the bladder neck and reduced the mobility from 34 degrees to 18 degrees with CCG and to 15 degrees with TM. Neither CCG nor TM had any adverse effect on the ability to elevate the bladder neck during squeezing. CONCLUSIONS: Vaginal devices are effective in alleviating stress incontinence and work by supporting a hypermobile bladder neck. The devices had no negative effect on the ability to contract the pelvic floor muscles. Ultrasonography is a fast and low invasive method to study effect of vaginal devices both in the individual patient and for testing new products.

Adult↗

An external urine-collection device for women: a clinical trial.

Urinary incontinence imposes physical, social, and economic hardships on those who face it. For many, pads and diapers are invaluable. Many types of condom catheters are available for men, but there are few similar devices for women. For the past 10 years, we have been developing an external urine-collection device for women. This device adheres between the labia to surround the urethra. The purposes of this first, descriptive clinical trial were (1) to examine the device for fit, urine containment, maintenance of vulvar skin integrity, and comfort; and (2) to describe microorganism changes to urine and periurethral and vaginal tissue in women wearing the device.

Adult↗

Comparisons of urodynamic characteristics between female patients with overactive bladder and overactive bladder plus stress urinary incontinence.

OBJECTIVES: To determine and compare the urodynamic characteristics in patients with overactive bladder (OAB) and patients with OAB plus stress urinary incontinence (OAB+SUI). METHODS: A total of 120 patients (60 each in OAB and OAB+SUI groups) who underwent urodynamic study between January and April 2003 were recruited. A detailed history, physical examination, and multichannel urodynamic data, including uroflowmetry, filling and voiding cystometry, stress urethral pressure profile, and 20-minute pad test were obtained for each patient. The urodynamic findings of each patient were analyzed and the results compared between the two groups. RESULTS: The median age of both groups was 51 years (interquartile range 43 to 64) with a parity of 3 (interquartile range 2 to 4); 54% (n = 65) were menopausal. The urodynamic parameters of bladder storage function showed premature filling sensation with decreased bladder capacity. Additionally, 60 (50%) had genuine stress incontinence, 3 (3%) had idiopathic detrusor overactivity, 11 (9%) mixed type incontinence, and 12 (11%) had voiding dysfunction. Among the urodynamic parameters between the two groups, first desire, strong desire, urgency, functional urethral length, maximal urethral pressure, maximal urethral closure pressure, pad test, and percentage of genuine stress incontinence in the OAB+SUI group were significantly lower statistically than those in the OAB group (P <0.03); the differences in age, parity, and percentage of menopausal status were also statistically significant (P <0.03). CONCLUSIONS: Our data showed that patients in the OAB+SUI group had more impaired urodynamic parameters than those in the OAB group. Age, parity, and menopausal status were contributory factors.

Adult↗