***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: The objective of this study was to evaluate the effectiveness of duloxetine in improving quality of life among women with stress and mixed urinary incontinence . The study included 451 women with self-reported stress incontinence episodes ( ≥1/week ) who were r and omized to duloxetine ( 40 mg BID ) or placebo  in a double-blind , usual care design . Patients and physicians were allowed to titrate , augment , and /or discontinue treatment . Concomitant treatments were permitted . The primary outcome was the Incontinence Quality of Life Question naire ( I-QOL ) score , with assessment s at 3 , 6 , and 9 months . Other measures included the Patient Global Impression of Improvement ( PGI-I ) and adverse events . The adjusted mean change in I-QOL total score was greater in the duloxetine group than in the placebo group and at a level comparable to that found in previous clinical trials , but the difference between placebo and duloxetine was not statistically significant in the intent-to-treat , last observation carried forward ( LOCF ) analysis . The difference approached statistical significance in favor of duloxetine at 3 months ( p=0.07 ) . PGI-I ratings did not demonstrate significant superiority for duloxetine in LOCF analysis ; however , study completers taking duloxetine were significantly more likely to rate themselves as “ better ” ( 70.2 % ) than completers taking placebo ( 50.8 % , p<0.05 ) . Women utilized a variety of treatment methods including pelvic floor muscle training , estrogen , anticholinergic medication , weight reduction , and smoking cessation . In this study , while mean I-QOL change scores were numerically higher for the duloxetine group than mean change scores for the placebo group , this difference was not statistically significant . Among women who completed the study on study drug , a significantly greater proportion of duloxetine women versus placebo women rated their condition to be better CONTEXT Pelvic floor electrical stimulation ( PFES ) has been shown to be effective for stress incontinence . However , its role in a multicomponent behavioral training program has not been defined . OBJECTIVE To determine if PFES increases efficacy of behavioral training for community-dwelling women with stress incontinence . DESIGN AND SETTING Prospect i ve r and omized controlled trial conducted from October 1 , 1995 , through May 1 , 2001 , at a university-based outpatient continence clinic in the United States . PATIENTS Volunteer sample of 200 ambulatory , nondemented , community-dwelling women aged 40 to 78 years with stress or mixed incontinence with stress as the predominant pattern ; stratified by race , type of incontinence ( stress only vs mixed ) , and severity ( frequency of episodes ) . INTERVENTIONS Patients were r and omly assigned to 8 weeks ( 4 visits ) of behavioral training , 8 weeks ( 4 visits ) of the behavioral training plus home PFES , or 8 weeks of self-administered behavioral treatment using a self-help booklet ( control condition ) . MAIN OUTCOME MEASURES Primary outcome was percentage reduction in the number of incontinent episodes as documented in bladder diaries . Secondary outcomes were patient satisfaction and changes in quality of life . RESULTS Intention-to-treat analysis showed that incontinence was reduced a mean of 68.6 % with behavioral training , 71.9 % with behavioral training plus PFES , and 52.5 % with the self-help booklet ( P = .005 ) . In comparison with the self-help booklet , behavioral training ( P = .02 ) and behavioral training plus PFES ( P = .002 ) were significantly more effective , but they were not significantly different from each other ( P = .60 ) . The PFES group had significantly better patient self-perception of outcome ( P<.001 ) and satisfaction with progress ( P = .02 ) . Significant improvements were seen across all 3 groups on the Incontinence Impact Question naire but with no between-group differences . CONCLUSIONS Treatment with PFES did not increase effectiveness of a comprehensive behavioral program for women with stress incontinence . A self-help booklet reduced incontinence and improved quality of life but not as much as the clinic-based programs Abstract Our aim was to study the association between menstrual cycle characteristics , the use of female hormones and urinary incontinence ( UI ) in an age-stratified r and om population sample of 2158 premenopausal women who answered a question naire on urinary incontinence . Episodes of UI during 1997 were reported by 18.3 % and one or more episodes of UI the preceding year by 3.9 % . Based on multiple logistic regression , self-reported UI the day before answering the question naire was found to be associated with current hormone use for menstrual disorders ( OR 2.7 , 95 % CI 1.2–6.6 ) , a recent decrease in bleeding duration ( OR 2.2 , 95 % CI 1.3–3.7 ) , being on days 11–15 before the expected end of the menstrual cycle the preceding day ( OR 2.6 , 95 % CI 1.3–5.0 ) , and with general UI risk factors , i.e. vaginal childbirth , childhood enuresis , BMI ⩾530 and exposure to abdominal and /or gynecologic surgery . The findings are in accordance with a hypothesis of hormonal variation being a risk indicator of UI in premenopausal women AIMS This prospect i ve , r and omized , controlled clinical trial was performed to demonstrate the 12 months safety and efficacy of transurethral radiofrequency energy ( RF ) collagen micro-remodeling in women with stress urinary incontinence ( SUI ) . MATERIAL S AND METHODS Women with SUI , bladder outlet hypermobility , and leak point pressure ( LPP ) > or = 60 cmH(2)O were r and omized to RF micro-remodeling or " sham treatment . "  Adverse events ( AEs ) were recorded . Incidence of > or = 10 point incontinence quality of life ( I-QOL ) score improvement , a magnitude of improvement with a demonstrated responsiveness to patient satisfaction with treatment and to > or = 25 % reduction in both incontinence episode frequency and stress pad weight , served as a subjective outcome measurement . Change in mean LPP served as an objective outcome measurement . RESULTS 110 women underwent RF micro-remodeling and 63 underwent virtually identical " sham treatment " ( with the exception of RF delivery ) . The 12 months RF micro-remodeling safety profile was statistically no different than that of sham treatment ( a brief bladder catheterization ) . Seventy-four percent of women with moderate to severe baseline SUI experienced > or = 10 point I-QOL score improvement at 12 months ( P = 0.04 ) . Women who underwent RF micro-remodeling demonstrated LPP elevation at 12 months , while sham treated women demonstrated LPP reduction ( P = 0.02 ) . CONCLUSIONS Non-surgical , transurethral RF micro-remodeling is a safe treatment for women with SUI . In women with moderate to severe SUI , this novel therapy result ed in statistically significant improvement in quality of life of a magnitude associated with patient satisfaction with the treatment . Women who underwent RF micro-remodeling demonstrated a statistically significant elevation in mean LPP at 12 months Recent cases of fraud in clinical trials have attracted considerable media attention , but relatively little reaction from the biostatistical community . In this paper we argue that biostatisticians should be involved in preventing fraud ( as well as unintentional errors ) , detecting it , and quantifying its impact on the outcome of clinical trials . We use the term ' fraud ' specifically to refer to data fabrication ( making up data values ) and falsification ( changing data values ) . Reported cases of such fraud involve cheating on inclusion criteria so that ineligible patients can enter the trial , and fabricating data so that no requested data are missing . Such types of fraud are partially preventable through a simplification of the eligibility criteria and through a reduction in the amount of data requested . These two measures are feasible and desirable in a surprisingly large number of clinical trials , and neither of them in any way jeopardizes the validity of the trial results . With regards to detection of fraud , a brute force approach has traditionally been used , whereby the participating centres undergo extensive monitoring involving up to 100 per cent verification of their case records . The cost-effectiveness of this approach seems highly debatable , since one could implement quality control through r and om sampling schemes , as is done in fields other than clinical medicine . Moreover , there are statistical techniques available ( but insufficiently used ) to detect ' strange ' patterns in the data including , but no limited to , techniques for study ing outliers , inliers , overdispersion , underdispersion and correlations or lack thereof . These techniques all rest upon the premise that it is quite difficult to invent plausible data , particularly highly dimensional multivariate data . The multicentric nature of clinical trials also offers an opportunity to check the plausibility of the data su bmi tted by one centre by comparing them with the data from all other centres . Finally , with fraud detected , it is essential to quantify its likely impact upon the outcome of the clinical trial . Many instances of fraud in clinical trials , although morally reprehensible , have a negligible impact on the trial 's scientific conclusions OBJECTIVE To evaluate the effect of a low‐intensity behavioral therapy program on urinary incontinence in older women . METHODS A r and omized clinical trial for community‐dwelling women at least 55 years reporting at least one urinary incontinent episode per week was conducted . Women were r and omly assigned to a behavioral therapy group ( n = 77 ) or a control group ( n = 75 ) . The treatment group had six weekly instructional sessions on bladder training and followed individualized voiding schedules . The control group received no instruction but kept urinary diaries for 6 weeks . After this period , the control group underwent the behavioral therapy protocol . Using per‐ protocol analyses , t and χ2 tests were used to compare the treatment and control groups , and paired t tests were used to evaluate the efficacy of behavioral therapy for all women ( treatment and control groups before and after behavioral therapy ) . RESULTS Women in the treatment group experienced a 50 % reduction in mean number of incontinent episodes recorded on a 7‐day urinary diary compared with a 15 % reduction for controls ( P = .001 ) . After behavioral therapy , all women had a 40 % decrease in mean weekly incontinent episodes ( P = .001 ) , which was maintained over 6 months ( P < .004 ) . Thirty ( 31 % ) women were 100 % improved ( dry ) , 40 ( 41 % ) were at least 75 % improved , and 50 ( 52 % ) at least 50 % improved . There were no differences in treatment efficacy by type of incontinence ( stress , urge , mixed ) or group assignment ( treatment , control ) . CONCLUSION A low‐intensity behavioral therapy intervention for urinary incontinence was effective and should be considered as a first‐line treatment for urinary incontinence in older women In a r and omized double-blind manner , 43 women with grade I and II stress urinary incontinence were treated with either phenylpropanolamine p.o . 50 mg twice daily ( Rinexin , 1 tablet b.i.d . ) or placebo during two weeks . Urethral CO2 profilometry , with recording of maximum urethral closure pressure ( MUCP ) and functional urethral length ( FUL ) , and subjective response were considered for effect evaluation . The subjective response of Rinexin was highly significant ( p = 0.01 ) above that of placebo .  Clinical improvement was reported by 15 of 21 women on Rinexin and by 8 of 22 women on placebo . A significant increase in MUCP , 14 % , was registered in women on Rinexin treatment . This increase was more pronounced in the grade I than in the grade II incontinent women . No statistically significant correlations were obtained between subjective response and increase in MUCP . An increase in FUL was recorded in both two treatment groups , but no statistically significant difference between them was obtained . Adverse drug reactions were rare . No changes in blood pressure occurred . Based on the present study , Rinexin ( 1 tablet b.i.d . ) is an effective and safe medication for female grade I and II stress incontinence and is also recommended as adjunctive therapy to physiotherapy before Teflon injection or operation The efficacy of bladder training was evaluated in a r and omized clinical trial involving 123 noninstitutionalized women 55 years and older with urinary incontinence . Subjects were urodynamically categorized as those with urethral sphincteric incompetence ( N = 88 ) and those with detrusor instability with or without concomitant sphincteric incompetence ( N = 35 ) . Bladder training reduced the number of incontinent episodes by 57 % ; the effect was similar for both urodynamic diagnostic groups . The quantity of fluid loss was reduced by 54 % . This was greater for patients with detrusor instability than for those without it . Diurnal and nocturnal voluntary micturitions were also reduced . The effect on nocturnal micturition , however , was not observed in subjects with unstable detrusor function . It is recommended that bladder training be considered as an initial step in treatment of women with urinary incontinence . Provided prior comprehensive clinical evaluation is done , it can be prescribed without the need for urodynamic characterization The purpose of our study was to compare the two st and ard routes of urethral bulking injection in a prospect i ve r and omized trial . Forty women with genuine stress incontinence ( n=36 ) , or mixed incontinence with a minor and controlled urge component ( n=4 
    Output:
    
Most studies examined short-term curative effects of treatment in participants with urinary incontinence .
Evidence of the Comparative Effectiveness of Clinical Interventions on Urinary Incontinence in Community-Dwelling Women Urinary continence after various interventions was defined as self-reported ability to control urination according to voiding