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[Artificial sphincter in severe urinary incontinence: 9 years of experience].

OBJECTIVE: To present the results achieved with the artificial urinary sphincter in the treatment of 44 patients with severe urinary incontinence. METHODS: From April 1990 to December 1998, an artificial urinary sphincter was implanted in 44 patients with severe urinary incontinence, aged 21 to 82 years (mean 56). These patients were categorized into the following groups: Group A comprised 24 males, aged 37 to 82 years (mean 66), who had undergone previous prostatic procedures. Four of them had undergone radical retropubic prostatectomy. The remaining 20 had undergone a total of 34 de-obstructive procedures (mean 1.7 procedures/patient; range 1-3); 28 were endoscopic procedures and 6 open prostatectomy. One of them had a previous ileocystoplasty due to severely low compliance. Ten were completely incontinent and were using a condom catheter (7), penile clamp (2) or permanent indwelling Foley catheter (1). The rest used a mean of 3.7 pads per day. Group B comprised 11 males with a complex urologic history: 9 had neurogenic dysfunction, 1 had bladder exstrophy and 1 had a previous cystectomy and Studer neobladder. Eight were using a condom catheter. The cuff was placed in the bulbar urethra in 8 (4-4.5 cm) and in the bladder neck in 4 (9-10 cm). Group C comprised 9 women with type III stress incontinence after failed previous interventions (range 1-4, mean 2.7). All of these patients required at least 3 pads per day (mean 4.5). The cuff was placed in the bladder neck with diameters ranging from 5 to 10 cm. RESULTS: The mean follow-up was 28.5 months (range 8-96). One patient died two years after implantation of the artificial sphincter which was never activated. In group A, 83% are socially continent and 17 do not require pads. Three of the 20 patients with the artificial sphincter have undergone a total of 4 surgical revisions. In group B, the social continence rate was 63% with a 36% revision rate. Four patients required a complete change of the system. In group C, The continence rate with revision was 66%. One patient underwent two successive successful revisions and 3 required removal of the device, accounting for a failure rate of 33%. Definitive removal of the artificial sphincter was required in 3 females and 5 males. Aside from one male who refused a new implant, the rest were considered unsuitable for a new device. Six patients underwent at least one reoperation to change one or more parts of the system. Continence was recovered in 66% after the revision. CONCLUSIONS: The artificial urinary sphincter achieves a good continence rate in patients with severe incontinence, although careful patient follow-up is required.

Adult↗

A new device for the treatment of female stress urinary incontinence.

Treatment for stress urinary incontinence (SUI) comprises a broad range of possible interventions. Non-surgical options include absorbent pads, vaginal weights and cones, biofeedback and minimally invasive techniques such as urethral bulking agents (UBAs). Surgical interventions range in complexity from sling surgery and suspension techniques to more major surgeries such as burch colposuspension. Each option has its challenges and limitations. This paper will focus on UBAs, which are implantable materials whose purpose is to augment urethral tissue function and restore continence. The characteristics required of such materials, and the challenges to be overcome when incorporating them in a successful product design, will be described and discussed. Particular attention will be given to the latest developments in the administration of polydimethylsiloxane elastomer UBA.

Biocompatible Materials↗

The long-term effect of adjuvant postoperative chemoradiotherapy for rectal carcinoma on bowel function.

OBJECTIVE: The authors assessed the long-term effect of postoperative chemoradiotherapy on bowel function. SUMMARY BACKGROUND DATA: Adjuvant postoperative radiation therapy, often combined with chemotherapy, is being used increasingly often for rectal carcinoma. However, the long-term effect of this treatment on bowel function has not been investigated. METHODS: The records were reviewed of all patients undergoing anterior resection for rectal carcinoma 2 to 5 years previously. During this period, patients with Astler-Coller stage B2 or C tumors generally were given postoperative radiation therapy with chemotherapy, whereas those with earlier stage tumors were not. To minimize possible confounding factors that may have been more common in the group receiving chemoradiotherapy and that may affect bowel function, extensive exclusion criteria were used, such as invasion of contiguous organs, local or distant metastases, use of a dysfunctioning stoma, and anastomotic or pelvic complications. One hundred remaining patients were suitable for inclusion in the study and participated in a telephone questionnaire; 41 patients had postoperative chemoradiotherapy, and 59 did not. RESULTS: The two groups were well matched for sex, level of anastomosis, and length of follow-up, although the group receiving chemoradiotherapy was slightly younger. The group that had chemoradiotherapy had more bowel movements per day than the group that did not have radiation therapy (median 7 vs. median 2, p < 0.001); the former group had "clustering" of bowel movements more often (42% vs. 3%, p < 0.001), had nighttime movements more often (46% vs. 14%, p < 0.001), had occasional or frequent incontinence more often (39% and 17% vs. 7% and 0%, p < 0.001), wore a pad more often (41% vs. 10%, p < 0.001), and were unable to defer defecation for more than 15 minutes more often (78% vs. 19%, p < 0.001). The group that had chemoradiotherapy also had stool of liquid consistency, used antidiarrheal medications, had perianal skin irritation, were unable to differentiate stool from gas, and needed to defecate again within 30 minutes of a movement significantly more often than the group that did not receive chemoradiotherapy. CONCLUSION: Adjuvant postoperative chemoradiotherapy for rectal carcinoma has a major long-term detrimental effect on bowel function.

Adenocarcinoma↗

Long-term intravesical oxybutynin chloride therapy in children with myelodysplasia.

PURPOSE: We evaluated the clinical use of long-term intravesical oxybutynin chloride in the treatment of neurogenic bladder dysfunction in children with myelodysplasia who could not tolerate oral anticholinergics. MATERIALS AND METHODS: We retrospectively reviewed the records of all patients recommended for intravesical oxybutynin chloride therapy. A total of 12 girls and 18 boys 1 to 17 years old was recruited for study. Oxybutynin chloride (5 mg.) was instilled 2 times daily and pretreatment cystograms were compared to followup urodynamic studies. Duration of therapy was 2 to 26 months (mean 13, median 12). RESULTS: Mean total capacity plus or minus standard deviation increased from 209 +/- 103 to 282 +/- 148 ml. (p < 0.01), mean safe capacity increased from 157 +/- 105 to 234 +/- 147 ml. (p < 0.01) and mean age adjusted safe capacity increased from 76 +/- 36 to 115 +/- 62%. Of the 29 patients who were incontinent 3 (10%) achieved continence and 19 (65%) reported a decreased use of sanitary pads. None of the patients had systemic side effects related to intravesical treatment. CONCLUSIONS: We believe that intravesical oxybutynin chloride is a viable treatment option for patients with myelodysplasia in whom oral therapy fails.

Administration, Intravesical↗

Artificial urinary sphincter for post-prostatectomy incontinence in men who had prior radiotherapy: a risk and outcome analysis.

PURPOSE: We retrospectively reviewed our experience with the artificial urinary sphincter for post-prostatectomy incontinence, comparing the outcome of those patients who did and did not receive previous radiation therapy. MATERIALS AND METHODS: A total of 86 patients with post-prostatectomy incontinence treated with implantation of artificial urinary sphincter includes 58 who did not (group 1) and 28 who did (group 2) receive prior radiation therapy during treatment of prostate carcinoma. In group 2 radiation was the primary treatment followed by salvage prostatectomy in 5 patients, adjuvant after radical retropubic prostatectomy 20 and after transurethral prostatic resection 3. Mean patient age plus or minus standard deviation was 68.3 +/- 6.6, and 69.7 +/- 6.6 years in groups 1 and 2, respectively. Activation of the sphincter was 4 weeks from the date of surgery, and deactivation at night was not adopted in either group. Patients were followed for a mean period of 31 +/- 23, and 36 +/- 21 months in groups 1 and 2, respectively. Comparison of continence, urodynamic testing, complication rate, overall satisfaction and quality of life was done between both groups. RESULTS: Reoperation was required in 13 (22.4%) patients in group 1 and 7 (25%) group 2 (p >0.05). Urethral atrophy and/or inadequate compression was seen in 8 (14%) and 4 (14%) patients, and urethral erosion was observed in 1 (2%) and 2 (7%) in groups 1 and 2, respectively (p >0.5). Infection of the device was observed in 4 (7%) patients in group 1 but none group 2 (p >0.05). Continence status was similar in both groups, with 60% and 64% of patients who wore 0 to 1 pad daily in groups 1 and 2, respectively (p >0.05). Urgency with or without urge incontinence was reported after implantation of artificial urinary sphincter in 47%, and 44% of patients in groups 1 and 2, respectively (p >0.05). On a visual analog scale (range 0 to 5, 0-not satisfied at all, 5-extremely satisfied) for satisfaction with the results of the artificial urinary sphincter 86% and 91% of patients reported 4 or greater in groups 1 and 2, respectively (p >0.05). CONCLUSIONS: The artificial urinary sphincter has a similar outcome in patients with post-prostatectomy incontinence whether or not they have received previous radiation therapy. No special precaution needs to be adopted for the men in group 2 with post-prostatectomy incontinence considering implantation of artificial urinary sphincter.

Aged↗

A unique cause of unconscious urinary incontinence.

The authors present a case of a healthy 55-year-old woman with a 1-year history of vaginal malodor and perineal dampness. A pyridium (phenazopyridine) pad test revealed a well-defined stain area no greater than 3 cm. Cystoscopic examination revealed multiple multilobulated polypoid neoplasms, which we feel probably represent pedunculated hemangiomas. Removal of the neoplasms cured the dampness, malodor and recurrent vaginal infections. We submit this case as a unique cause of extraurethral incontinence.

Female↗

Combined tension-free vaginal tape and prolapse repair under local anaesthesia in patients with symptoms of both urinary incontinence and prolapse.

OBJECTIVE: To study the combination of tension-free vaginal tape (TVT) and prolapse repair under local anaesthesia in patients suffering from stress incontinence and prolapse. STUDY DESIGN: The study was designed as a prospective, open, nonrandomized study. A standardized protocol was used for pre- and postoperative evaluation. Check-ups were performed after 2, 6, 12 and 24 months. The protocol included medical history, stress test (supine and standing position with a comfortably filled bladder), life quality assessment including a visual analogue scale, 24- to 48-hour pad test, and 48-hour micturition diary. PATIENTS: In total 32 patients participated. All suffered from urinary stress incontinence (grade 1-3) and prolapse (grade 1-3). 2 patients had previously undergone surgery 2 and 3 times, respectively, for urinary incontinence with methods other than TVT (traditional anti-incontinence surgery). 3 patients had a history of total hysterectomy. 1 patient had a large rectocele with urinary and faecal incontinence. Mean age was 54 (range 31-74) years, mean parity 2 (range 0-5), and mean duration of incontinence 13 (range 2-29) years. SURGICAL TECHNIQUE: TVT was carried out according to the standardized technique as originally described. The prolapse repair included anterior and/or posterior colporrhaphy. All operations could be performed under local anaesthesia. RESULTS: 30 of 32 patients (93%) were cured. One patient (3%) was considerably improved, and 1 patient (3%) was considered a failure. Mean urinary leakage in 24 h was 96 (range 12-355) g preoperatively, and postoperatively 2.7 (range 0-28) g. Mean intraoperative bleeding was 75 (range 25-300) ml. Mean residual urine preoperatively was 15 (range 0-85) ml, and postoperatively 7 (range 0-40) ml. The mean stay in hospital after surgery was 2 (range 1-5) days. No postoperative urinary retention, no defective healing, and no tape rejection occurred. There was one uneventful bladder perforation in a patient who had previously undergone traditional incontinence surgery. This patient left the hospital the day after surgery without postoperative catheterization. CONCLUSION: The study clearly demonstrates that TVT can be combined with prolapse surgery to effectively treat symptoms of prolapse and urinary stress incontinence.

Adult↗

The prevalence of urinary incontinence in women in four European countries.

OBJECTIVE: To determine the prevalence, type and treatment behaviour of women with urinary incontinence in four European countries. SUBJECTS AND METHODS: Data were collected using a postal survey which was sent to 29,500 community-dwelling women aged > or = 18 years in France, Germany, Spain and the UK. Subjects were asked about the type of urinary incontinence they had experienced and their treatment behaviour. RESULTS: Of the women who responded, 35% reported involuntary loss of urine in the preceding 30 days; stress urinary incontinence was the most prevalent type. The lowest prevalence was in Spain (23%), while the prevalence was 44%, 41% and 42% for France, Germany and the UK, respectively. About a quarter of women with urinary incontinence in Spain (24%) and the UK (25%) had consulted a doctor about it; in France (33%) and Germany (40%) the percentages were higher. Overall, <5% of the women had ever undergone surgery for their condition. While pads were used by half of the women, there were some differences among the countries. CONCLUSIONS: Millions of women in Europe have urinary incontinence; the consultation and treatment rates were low in the European countries included in this study.

Adolescent↗

Duloxetine versus placebo for the treatment of North American women with stress urinary incontinence.

PURPOSE: Duloxetine, a selective serotonin and norepinephrine reuptake inhibitor, increases rhabdosphincter contractility via the stimulation of pudendal motor neuron alpha-1 adrenergic and 5-hydroxytryptamine-2 receptors. In this first phase 3 study we assessed the efficacy and safety of duloxetine in women with stress urinary incontinence (SUI). MATERIALS AND METHODS: A total of 683 North American women 22 to 84 years old were enrolled in this double-blind, placebo controlled study. The case definition included a predominant symptom of SUI with a weekly incontinence episode frequency (IEF) of 7 or greater, the absence of predominant symptoms of urge incontinence, normal diurnal and nocturnal frequency, a bladder capacity of 400 ml or greater, and a positive cough stress test and stress pad test. After a 2-week placebo lead-in period subjects were randomly assigned to receive placebo (339) or 80 mg duloxetine daily (344) as 40 mg twice daily for 12 weeks. Primary outcome variables included IEF and an incontinence quality of life questionnaire. Van Elteren's test was used to analyze percent changes in IEF with a stratification variable of weekly baseline IEF (less than 14 and 14 or greater). ANCOVA was used to analyze incontinence quality of life scores. RESULTS: Mean baseline IEF was 18 weekly and 436 subjects (64%) had a baseline IEF of 14 or greater. There was a significant decrease in IEF with duloxetine compared with placebo (50% vs 27%, p <0.001) with comparably significant improvements in quality of life (11.0 vs 6.8, p <0.001). Of subjects on duloxetine 51% had a 50% to 100% decrease in IEF compared with 34% of those on placebo (p <0.001). These improvements with duloxetine were associated with a significant increases in the voiding interval compared with placebo (20 vs 2 minutes, p <0.001) and they were observed across the spectrum of incontinence severity. The discontinuation rate for adverse events was 4% for placebo and 24% for duloxetine (p <0.001) with nausea the most common reason for discontinuation (6.4%). Nausea, which was also the most common side effect, tended to be mild to moderate and transient, usually resolving after 1 week to 1 month. Of the 78 women who experienced treatment emergent nausea while taking duloxetine 58 (74%) completed the trial. CONCLUSIONS: These phase 3 data are consistent with phase 2 data and they provide further evidence for the safety and efficacy of duloxetine as a pharmacological agent for the treatment of women with SUI.

Adult↗

Pad-weighing test performed with standardized bladder volume.

The result of the one-hour pad-weighing test proposed by the International Continence Society has been demonstrated to depend on the urine load during the test. To increase reproducibility of the pad-weighing test by minimizing the influence of variation in urine load the test was done with a standardized bladder volume (50% of the cystometric bladder capacity). Twenty-five female patients with stress or mixed incontinence underwent two separate tests. Test-retest results were highly correlated (r = 0.97, p less than 0.001). Nonetheless, analysis of test-retest differences revealed a variation up to +/- 24 g between two tests. It is concluded that this setup (i.e., standardized bladder volume) of the one-hour pad-weighing test allows for a more reliable assessment of urinary incontinence for quantitative purposes.

False Negative Reactions↗

[Clinical, urodynamic and radiologic parameters for determining success following surgery of incontinence].

The basis of any quality control after surgery for SUI is objective control by pre- and postoperative quantification of urinary loss. Whereas a clinical stress test or the ICS pad-weigh-test allows to quantify, history as well as urodynamic data do not. For analysis of failures the whole diagnostic range (history, urodynamic, radiology/sonography, gynecologic examination) is needed, which enables to decide about second line therapy. Voiding difficulties and urge-incontinence after surgery for SUI are major complications and have to be critically analysed.

Female↗

Pelvic floor electrical stimulation for the treatment of urge and mixed urinary incontinence in women.

OBJECTIVES: To determine the efficacy of daily or every-other-day electrical stimulation in treating detrusor instability (urge) or urge plus genuine stress (mixed) urinary incontinence in women. METHODS: A multicenter, prospective, nonrandomized study enrolled subjects with urge and mixed urinary incontinence assigned to daily or every-other-day treatments (15 minutes twice daily) using pelvic floor stimulation. Outcome measures assessed were (1) leakage episodes, nocturnal episodes, voiding frequency, total voids, and pad count, and (2) patient subjective assessment and quality of life. RESULTS: Seventy-two subjects were enrolled. Sixty-eight subjects completed the 20-week protocol: 33 treated daily and 35 treated every other day. The entire study group (n = 68) experienced a significant decrease in total leaks (P < 0.001), nocturnal episodes (P = 0.001), pad count (P = 0.002), and total voids (P = 0.003) and on visual analog scales. Sixty-nine percent (n = 46) of subjects with urge or mixed incontinence were cured or improved by at least 50%, with 28% (n = 19) being cured. There were no significant differences between daily and every-other-day users. Nonresponse was correlated with number of previous therapies (P < 0.001) and number of vaginal deliveries (P = 0.007). Overall, subjects were 93% compliant with device use, and 72% (n = 47) were satisfied with the therapy. CONCLUSIONS: Twenty weeks of pelvic floor electrical stimulation therapy is effective in treating urge and mixed urinary incontinence, regardless of daily or every-other-day treatments.

Adult↗

Discreet products for children and teenagers with continence problems.

The National Service Framework for Children, Young People and Maternity Services (Department of Health, 2004a) estimates that 'at least 500,000 children suffer from nocturnal enuresis, and a significant number with daytime wetting and faecal incontinence'. The NSF also acknowledges that 'incontinence is distressing for children and young people; it can lead to bullying at school and cause emotional and behavioural problems'.

Absorbent Pads↗

The use of an artificial urinary sphincter in women with type III incontinence and a negative Marshall test.

PURPOSE: We evaluate the efficacy of the AMS 800 artificial urinary sphincter in women with type III incontinence. MATERIALS AND METHODS: We enrolled 207 women with genuine stress incontinence due to intrinsic sphincter deficiency. Primary inclusion criterion was a negative Marshall test. A modified surgical procedure was used to implant the AMS 800 through an abdominal approach, with placement of the cuff around the bladder neck between the periurethral fascia and vagina. Followup data were available for 206 women, including 179 with nonneurogenic and 27 with neurogenic bladders (mean followup 3.9 years). RESULTS: There were 12 (5.9%) explantations due to the prosthesis either through an erosion, extrusion or both that were necessary. The only significant risk factor for explantation was perioperative injury. This injury resulted in 8 explantations in 49 patients compared with 4 in 155 who did not have such injuries (p = 0.0016). Of the 190 patients with working devices continence was achieved in 88.7% (49 of 168) and 81.8% (18 of 22) of those with nonneurogenic and neurogenic bladders, respectively. Social continence (slight leakage but no pad use) was reported by 7.7% (13 of 168) and 9.1% (2 of 22) of patients in the nonneurogenic and neurogenic groups, respectively. The remaining patients reported leakage and pad use. CONCLUSIONS: The AMS 800 can be used successfully to treat women with genuine stress incontinence due to intrinsic sphincter deficiency. The modified surgical approach resulted in fewer perioperative injuries and, consequently, a low explantation rate. Women with genuine stress incontinence, a low urethral closure pressure and negative Marshall test indicating severe intrinsic sphincter deficiency are potential candidates for artificial urinary sphincter implantation.

Adult↗

Simple urodynamic techniques.

Urodynamics is defined as a set of tests used to measure lower urinary tract function. For many health care professionals, the term urodynamics is limited to complex techniques that require sophisticated analog or computerized equipment capable of measuring flow, pressure, and electromyography. However, simple urodynamic techniques offer continence nurses and their patients a set of practical, safe, and inexpensive methods for the evaluation of urinary incontinence. This article provides specific indications for simple urodynamic evaluation, with a detailed discussion of application and interpretation of patient history, bladder records, pad tests, observation of urinary stream, postvoid residual measurement, and bedside cystometry with "eyeball" and manometer techniques.

Decision Trees↗

Canadian economic comparison of extended-release oxybutynin and immediate-release tolterodine in the treatment of overactive bladder.

BACKGROUND: Overactive bladder (OAB) is a condition characterized by urgency, increased frequency of micturition, or urge incontinence. It affects a considerable segment of the population, particularly with increasing age. Pharmacotherapy is one of the most common approaches to the treatment of OAB. OBJECTIVE: This article describes the development and results of a model comparing health-economic outcomes for the new extended-release (XL) formulation of oxybutynin and immediate-release (IR) tolterodine in a population of community-dwelling Canadian adults with OAB. METHODS: A Markov model was developed to compare health-economic outcomes over the course of 1 year. Effectiveness and treatment-persistence data were derived from the OBJECT (Overactive Bladder: Judging Effective Control and Treatment) trial, a 3-month comparison of oxybutynin XL 10 mg and tolterodine IR 4 mg, and were used, together with data from the literature (identified through a MEDLINE search of articles published between 1990 and 2003), to project outcomes beyond the trial period. Severity-specific cost profiles for incontinence were developed. In the principal analyses, cost items were limited to drug therapy, physician visits, use of pads or other protection, and laundry costs. Costs are reported in 2002 Canadian dollars. RESULTS: Costs after 1 year were estimated to be an average of $32 less per patient for oxybutynin XL compared with tolterodine IR, and 3.1 additional patients in every 100 who received oxybutynin XL were expected to attain complete continence compared with those who received tolterodine. During the course of 1 year, patients receiving oxybutynin XL were expected to have a mean 16.5 additional incontinence-free days compared with those receiving tolterodine IR. The results were sensitive to relative drug prices. In the other sensitivity analyses, however, oxybutyrin XL maintained its advantage over a wide range of inputs. CONCLUSION: The results of these analyses suggest that when priced equivalently, oxybutynin XL would reduce costs and provide better results than tolterodine IR over 1 year of treatment.

Benzhydryl Compounds↗

Periurethral polytetrafluoroethylene injection following urethral reconstruction in female patients with urinary incontinence.

We present our results with periurethral polytetrafluoroethylene (Polytef) injection after urethral reconstruction in 20 female patients with urinary incontinence. These patients have failed previous urethral reconstructive procedures to cure incontinence, including Young-Dees-Leadbetter bladder neck reconstruction, transvaginal urethroplasty, transvaginal urethral plication and vesical flap urethroplasty. Of the patients 4 also underwent a bladder augmentation procedure. After polytetrafluorethylene injection 10 patients (50 per cent) were cured of the incontinence, 2 (10 per cent) had marked improvement from the preoperative condition, 5 (25 per cent) had definite improvement but still wear pads for protection and 3 (15 per cent) had no change from the preoperative condition. Bladder pressure recordings did not demonstrate a difference in results among patients with detrusor stability or instability. Periurethral polytetrafluoroethylene injection remains a valuable procedure in the management of persistent incontinence after bladder neck and urethral reconstruction.

Adult↗

A prospective, randomized controlled trial of inpatient versus outpatient continence programs in the treatment of urinary incontinence in the female.

Seventy-four patients presenting with a mixed pattern of urinary symptoms were randomly allocated to undergo either inpatient or outpatient continence programs as initial treatment, without prior urodynamic investigation. Both programs consisted of physiotherapy, bladder retraining, fluid normalization, dietary advice and general support and advice. Nine out of 39 in the outpatient group and 8 out of the 35 of the inpatient group failed to complete the study. There was a significant decrease in frequency, nocturia, number of incontinent episodes and visual analog scores for both groups. In addition the outpatients had a significant reduction in loss on pad testing, and a significantly greater improvement in their visual analog score. In each group 63% were cured or improved to the extent that they did not require further treatment. Staff costs per outpatient were half those for an inpatient. We conclude that outpatient conservative treatment as detailed above is a successful first-line treatment of urinary incontinence in women. It is as successful and possibly better than inpatient treatment, and is significantly cheaper.

Adult↗