***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: An investigation was carried out on six hospitalized elderly male urinary incontinent patients for 21 days to test three urinary sheath systems by means of a quasi-experimental trial , incorporating crossover . Observations were made , and recorded , of detachment or leakage in systems and of skin condition round the shaft of the penis . Results suggest that two of the systems differ significantly in their performance and that performance of the urinary sheath was probably the limiting factor in overall performance . Incidence of skin problems , and other problems within systems , were minimal . It was also observed that patients differ significantly in their suitability for the application of sheath systems . This observation was made at two time intervals . A further line of investigation is suggested to test the effect of components , other than sheaths , on performance of systems A new system of  urine collection to be used with  indwelling catheters or condom drainage  was developed and evaluated in the laboratory , and clinical ly . The aims included prevention of twisting of the tubes , non-leakage , comfortable body bags and ease of use of drainage taps . The new system was highly acceptable to patient and attendant alike 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 Urethral devices are one conservative management option for stress and mixed urinary incontinence , but there is little published data about their use . The aims of this study were to assess the safety and efficacy of a new urethral device ( NEAT ) and compare it with the Reliance Insert . The ease of use of both devices was then evaluated . Twenty-four women with mixed or stress urinary incontinence , patients at our tertiary care urogynecology unit and who met the inclusion and exclusion criteria , were enrolled in the study . Study subjects were blinded and r and omly assigned to a device group . Device efficacy was assessed by pad weighing at 0 and 4 months . Success was defined as a 50 % or greater reduction in urine loss using the formula 100[(pad weight without device −pad weight with device)/pad weight with device ] . Safety was evaluated using urinalysis and urine cultures . Ease of use assessment scales were also completed . Eleven patients were r and omized to the Reliance Insert and 13 to the NEAT device . There were no significant differences between the two groups in age , height , weight , duration of incontinence , pad weight , leakage score , parity or quality of life score . Based on the pad weight success formula , there was no significant difference in device success between the two groups at 4 months . Women who were postmenopausal had a trend towards a higher level of success in reduction of their pad weight . Previous treatment , diagnosis and hormone replacement therapy all had no relationship to device success . Leakage score data showed that subjects had a significant decrease in urine leakage when using either device . There was no statistically significant difference in ease of use between the two devices . Adverse symptoms most commonly noted were awareness of the device ( 62.5 % ) , urgency ( 29.2 % ) , and urethral discomfort or pain ( 20.8 % ) . One urinary tract infection ( UTI ) was observed . The most common finding on urinalysis was trace hematuria ( 15.8 % ) . Our conclusions are that the NEAT device appears to be at least as effective and safe as the Reliance Insert . Both devices are effective at decreasing urine leakage in patients with stress or mixed urinary incontinence . The risk of UTI is low , but these devices may cause trace hematuria Objective The objective of this study was to determine if differences exist in pelvic symptom distress and impact on women r and omized to pessary versus behavioral therapy for treatment of stress urinary incontinence ( SUI ) . Methods Change in symptom and condition-specific health-related quality -of-life ( HRQOL ) measures were compared between pessary and behavioral groups 3 months after r and omization in the Ambulatory Treatments for Leakage Associated With Stress Incontinence trial . Four hundred forty-six women with symptoms of SUI were r and omized to continence pessary , behavioral therapy ( pelvic floor muscle training and continence strategies ) or combination therapy . Vali date d measures utilized included urinary , prolapse , and colorectal scales of the Pelvic Floor Distress Inventory ; urinary , prolapse , and colorectal scales of the Pelvic Floor Impact Question naire ; and Stress and Urge scales of the Question naire for Urinary Incontinence Diagnosis . Student t test and analysis of variance were used to compare scores within and between groups . Results Mean age of participants was 49.8 ( SD , 11.9 ) years ; 84 % were white , and 10 % were African American . One hundred forty-nine were r and omized to pessary , and 146 to behavioral therapy .  Baseline symptoms and HRQOL scores were significantly reduced within treatment arms at 3 months after r and omization , but there was no statistically significant difference between groups . Conclusions There was no difference in pelvic floor symptom bother and HRQOL between the pessary and behavioral therapy arms in women undergoing conservative treatment for SUI . Individualized preference issues should be considered in the approach to the nonsurgical treatment of SUI A developed urethral plug  was evaluated for the treatment of women with genuine urinary stress incontinence . The plug consists of an oval meatal plate , a soft stalk and one or two spheres along the stalk with fixed distances between the meatal plate and the spheres . Inside the stalk is a removable semi-rigid guide pin to ease insertion . Forty women were r and omly allocated to treatment with either the two-sphere or the one-sphere plug during period one ( two weeks ) . In period two ( two weeks ) the patients used the other plug . They then continued with what they judged to be the better plug in period three ( two months ) . Eighteen patients ( 45 % ) completed period three with the " preference " plug and 17 were subjectively and objective ly continent or improved . Fourteen of these women preferred the two-sphere device . The plugs were equally effective in patients with mild or severe incontinence . Six women developed urinary tract infections and two of these had a plug in the bladder . The urethral plug is an effective treatment in a group of women with stress incontinence . Removal by h and is advisable in order to avoid retention of plugs in the bladder Introduction and hypothesisManagement of stress urinary incontinence ( SUI ) with intravaginal devices is an alternative to surgical management , but data of a high level of evidence remain scarce . Our goal was to assess efficacy , tolerance , and acceptability of the 75NC007 intravaginal device for SUI management . Methods A phase III , multicenter r and omized controlled trial was conducted . After an initial washout period with no treatment , allowing baseline evaluation , women with SUI were r and omly assigned to a treatment or control group ( no treatment ) . The primary endpoint was the reduction of incontinence episode frequency ( IEF ) , according to bladder diaries , as compared to baseline . Secondary endpoints were variation of the Urinary Symptom Profile ( USP ) score , of 24-h pad test , and of CONTILIFE question naire scores as compared to baseline . Intent-to-treat and per- protocol analyses were conducted . Results Fifty-five patients were enrolled and analyzed ( 26 controls and 29 treated ) . The mean relative variations of IEF , SUI USP subscore , and overactive bladder ( OAB ) USP subscore were more significant in the treatment group than in the control group ( −31.7 ± 65.1 % vs −7.6 ± 24.5 % , p = 0.002 , −2.4 ± 2.6 vs 0.2 ± 2.2 , p = 0.004 , and −1.5 ± 2.8 vs 0.2 ± 1.8 , p = 0.016 , respectively ) . The dysuria USP subscore was slightly decreased in the treatment group . CONTILIFE scores were slightly improved in the treatment group . Pad test variations were not different between groups . No serious adverse event was noted throughout the entire study . Conclusions The 75NC007 intravaginal device is a safe and effective noninvasive treatment of SUI in women PURPOSE We evaluated the usefulness and safety of a bladder neck support prosthesis in patients with stress or mixed incontinence . MATERIAL S AND METHODS A total of 57 women with stress and 20 with mixed incontinence completed a 12-week prospect i ve clinical trial of a bladder neck support prosthesis . While indexes of incontinence episodes , leakage amounts and urgency along with a bothersome index were subjectively evaluated , a 60-minute pad test and urinary flow parameters were objective ly evaluated . Three patients scheduled to undergo surgery for stress incontinence voluntarily used the device , and provided urodynamic data and cystourethrograms . Two prongs at 1 end of the ring , a type of elastic vaginal pessary , elevate the bladder neck against the pubic bone and facilitate pressure transmission around the bladder neck , result ing in urinary continence . RESULTS Four subjective indexes significantly improved . There was no urinary flow obstruction . Urine loss decreased from 20.6 to 4.8 gm . per hour ( p < 0.001 ) on the 60-minute pad test . Of the patients 22 ( 29 % ) reported complete continence and 39 ( 51 % ) had decreased severity of incontinence by more than 50 % . Minor adverse effects occurred in 26 % of the patients . Taking subjective evaluation , changes in objective parameters and adverse effects into consideration , 62 patients ( 81 % ) had some or maximum benefit according to the global usefulness rating . CONCLUSIONS The bladder neck support prosthesis is safe , well tolerated and clinical ly effective for the treatment of stress or mixed incontinence OBJECTIVE : To identify factors that may predict success and satisfaction in women undergoing nonsurgical therapy for stress urinary incontinence . METHODS : Baseline demographic and clinical characteristics of women participating in a multicenter r and omized trial of pessary , behavioral , or combined therapy for stress urinary incontinence were evaluated for potential predictors of success and satisfaction . Success and satisfaction outcomes were assessed at 3 months and included the Patient Global Impression of Improvement , stress incontinence subscale of the Pelvic Floor Distress Inventory , and Patient Satisfaction Question naire .  Logistic regression was performed to identify predictors , adjusting for treatment and other important clinical covariates . Adjusted odds ratios ( ORs ) , 95 % confidence intervals ( CIs ) , and associated P values are presented . RESULTS : Four hundred forty-six women were r and omized . College education or more and no previous urinary incontinence surgery predicted success based on the stress subscale of the Pelvic Floor Distress Inventory ( adjusted OR 1.61 , 95 % CI 1.01–2.55 , P=.04 and adjusted OR 3.15 , 95 % CI 1.04- 9.53 , P=.04 , respectively ) . Menopausal status predicted success using the Patient Global Impression of Improvement ( adjusted OR 2.52 postmenopausal compared with premenopausal , 95 % CI 1.29–4.95 ; adjusted OR 1.32 unsure menopausal status compared with premenopausal , 95 % CI 0.65–2.66 ; P=.03 across all three groups ) . Fewer than 14 incontinence episodes per week predicted satisfaction with the Patient Satisfaction Question naire ( adjusted OR 1.97 , 95 % CI 1.21–3.19 ; P=.01 ) . These predictors did not differ across the three treatment groups . CONCLUSION : Menopause , higher education , no previous urinary incontinence surgery , and lower incontinence frequency were found to be predictors of success and satisfaction with nonsurgical therapy for stress urinary incontinence . This information may help better-align provider and patient expectations with nonsurgical treatment outcomes . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00270998 . LEVEL OF EVIDENCE : OBJECTIVES The purpose of this study was to test the safety and effectiveness of a urethral insert for managing stress or mixed urinary incontinence . METHODS We performed a prospect i ve , multicenter study of 135 female patients who were treated for 4 months with the Reliance Urinary Control Insert .  The effectiveness of the insert was measured objective ly at the time of first use and after 4 months ' use by st and ardized pad weight studies . Insert effectiveness was also measured by reports of symptom improvement during patient interviews and on patient diaries . Urine microscopy and culture were obtained monthly ; cystoscopy and urodynamics were conducted at study entry and at 4 months . RESULTS Significant improvement in involuntary urine loss was observed . Objective measurement of urine loss revealed that 80 % of the patients were completely dry , and 95 % of the patients achieved greater than an 80 % decrease in urine loss . In addition , patients ' perceptions of acceptability , incontinence symptom improvement , ease of learning , comfort , and time to habituation also showed improvements . Untoward events reported during the study included hematuria , bacteriuria , and bladder irritation . These events did not require significant medical intervention and did not result in any long-term clinical sequelae . CONCLUSIONS These preliminary results indicate that 
    Output:
    
Three small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment , the evidence for this was inconclusive .
While at three months there were more withdrawals from the device-only group , at 12 months differences between the groups were not sustained on any measure .
The place of mechanical devices in the management of urinary incontinence remains in question .
There was also insufficient evidence in favour of one device over another and little evidence to compare mechanical devices with other forms of treatment