[Summary text]
RCT
Inclusion:Urinary incontinence (min 5 episodes of UI in 3 d voiding diary) of any kind.
BMI > 25
Exclusion: Medical therapy for UI within a month
Attempt to weight loss within a month
Urinary tract infection within 6 months
Pregnancy or parturition within 6 months
Previous genitourinary surgery
Patients with UI due to neurological or functional origins, or with significant systemic and genitourinary medical conditions, and women who required
Characteristics: intevention/control
Age: 44.1 (8.6)/ 43.8 (9.7)
BMI: 32.7 (4.1)/ 32.3 (3.6)
UUI: 34 (21%)/40 (25%)
Mixed UI: 63 (39%)/
SUI: 66 (41%)/62 (39%)
POP Min stg.2: 47 (29%)/ 50 (32%)
Intervention:
Et superviseret vægttabsprogram omhandlende kost og fysisk aktivitet. Kalorierestiktion 1200-1800 kcal/dgl. Månedlig fremmøde. Mål samlet vægttab 7-9% af udgangsvægt.
6 months treatment, 6 months follow up
Control:
Ingen. Alle (intervention + control) deltog i en fælles undervisning omhandlende vægttab, kost, motion og dets betydning for urininkontinens.
6 months treatment, 6 months follow up
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: included individuals at 16 clinical centers.Eligibility criteria were age 45 to 76 years and a BMI of25 kg/m2 or greater (greater than 27 kg/m2 if currentlytaking insulin). Major exclusions included HbA1c 11%or greater, blood pressure 160/100 mm Hg or greater,triglycerides 600 mg/dl or greater, inadequate control ofcomorbid conditions, factors that may limit adherenceto the intervention, and underlying disease likely tolimit life span and/or affect safety of the interventions.
Excluded criteria: Major exclusions included HbA1c 11% or greater, blood pressure 160/100 mm Hg or greater,triglycerides 600 mg/dl or greater, inadequate control ofcomorbid conditions, factors that may limit adherence to the intervention, and underlying disease likely to limit life span and/or affect safety of the interventions. For the purpose of this substudy men were also excluded.
Intervention Characteristics
Intervention
Control
Inkontinensrelateret livskvalitet
Antal tilfælde af inkontinens/uge
Patientoplevet effekt
Vægt
BMI
Frafald
Antal opereret med midturethral slynge
antal kvinder med inkontinens
Sponsorship source: Supported by the Department of Health and Human Services through cooperative agreements from the National Institutes of Health DK57136,DK57149, DK56990, DK57177, DK57171, DK57151, DK57182, DK57131, DK57002, DK57078, DK57154, DK57178, DK57219, DK57008, DK57135and DK56992; the National Institute of Diabetes and Digestive and Kidney Diseases; National Heart, Lung, and Blood Institute; National Instituteof Nursing Research; National Center on Minority Health and Health Disparities; Office of Research on Women’s Health; Centers for DiseaseControl and Prevention; Intramural Research Program of the National Institute of Diabetes and Digestive and Kidney Diseases; The Johns HopkinsMedical Institutions Bayview General Clinical Research Center (M01-RR-02719); the Massachusetts General Hospital Mallinckrodt General ClinicalResearch Center (M01-RR-01066); the University of Colorado Health Sciences Center General Clinical Research Center (M01 RR00051) and ClinicalNutrition Research Unit (P30 DK48520); the University of Tennessee at Memphis General Clinical Research Center (M01RR00211-40); theUniversity of Pittsburgh General Clinical Research Center (M01 RR000056 44); National Institutes of Health Grant DK 046204; University ofWashington/VA Puget Sound Health Care System Medical Research Service, Department of Veterans Affairs; and National Institute of Diabetesand Digestive and Kidney Diseases K-24 Midcareer Investigator Award in Patient Oriented Research PA-98-053 (JSB, LLS).
Country: USA
Setting: Clinical
Comments:
Authors name: Suzanne Phelan
Institution:
Email:
Address:
Jens Aaboe on 06/08/2015 21:05
Participants
Inclusion criteria used in this substudy: age 45 to 76 years, were not specified in the original study with Clinical Trial Registration NCT00017953.
Julie Hansen on 06/08/2015 22:02
Continuous Outcomes
Data on weight loss are presented in trial; see RCT when making analyses
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Women 18 to 80 years old with BMI between 25 and 45 kg/m2, urinary incontinence for at least 3 months and at least 4 incontinent episodes in a 7-day urinary diary. Prior incontinence therapies (including surgery) were not exclusions from the study eligibility. Participants currently using incontinence therapy were included in the study but were asked to not change treatment during study.
Excluded criteria: Exclusion criteria included pregnancy, urinary tract infection, significant medical condition, pelvic cancer, neurological condition possibly associated with incontinence, interstitial cystitis or potential inability to complete the study.
Intervention Characteristics
Intervention
Control
Inkontinensrelateret livskvalitet
Antal tilfælde af inkontinens/uge
Patientoplevet effekt
Vægt
BMI
Frafald
Antal opereret med midturethral slynge
Sponsorship source: Supported by research awards from Mount Zion Health Services, Inc. and the University of California, San Francisco Academic Senate, Committee on Research.
Country: USA
Setting:
Comments:
Authors name: Subak 2005
Institution:
Email:
Address:
Britta Tendal on 09/07/2015 23:28
Continuous Outcomes
In the paper most outcomes are given as median and IQR. The median is used as a mean and the IQR/1.35 is used as the SD
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Women were eligible for the study if they were at least 30 years of age, had a body-mass index of 25 to 50, and at baseline reported 10 or more urinary-incontinence episodes in a 7-day diary of voiding. The participants were required to monitor their food intake and physical activity for 1 week, to be able to walk unassisted for two blocks (approximately 270 m) without stopping, and to agree not to initiate new treatments for incontinence or weight reduction for the duration of the study.
Excluded criteria: use of medical therapy for incontinenceor weight loss within the previous month, currenturinary tract infection or four or more urinarytract infections in the previous year, a history ofincontinence of neurologic or functional origin(due to factors not involving the lower urinarytract, such as chronic impairment of physical orcognitive functioning), previous surgery for incontinenceor urethral surgery, major medical orgenitourinary tract conditions, pregnancy or parturitionin the previous 6 months, type 1 or type 2diabetes mellitus requiring medical therapy thatincreased the risk of hypoglycemia, and uncontrolledhypertension.
Intervention Characteristics
Intervention
Control
Inkontinensrelateret livskvalitet
Any Antal tilfælde af inkontinens/uge
Patientoplevet effekt
Vægt
BMI
Frafald
Antal opereret med midturethral slynge
Stress incontinence
Urge incontinence
Sponsorship source: Supported by grants from the National Institute of Diabetesand Digestive and Kidney Diseases (NIDDK) (U01 DK067860,U01 DK067861, and U01 DK067862) and from the Office of Researchon Women’s Health.Dr. Subak reports serving on an advisory board for Pfizer andreceiving grant support from Pfizer; Dr. Grady, receiving grantsupport from Bionovo; Dr. Kusek, owning stock in Eli Lilly, Pfizer,and deCODE Genetics; and Dr. Burgio, serving on an advisoryboard for Pfizer, receiving grant support from Pfizer, and receivingadvisory-board fees from Astellas and GlaxoSmithKline. No otherpotential conflict of interest relevant to this article was reported
Country: USA
Setting:
Comments:
Authors name: Subak et al
Institution:
Email:
Address:
Julie Hansen on 04/08/2015 21:11
Continuous Outcomes
Mean difference Change values are presented in results section i RCT for 'weight';
Julie Hansen on 04/08/2015 21:24
Dichotomous Outcomes
Dropout are presented for 'number who returned status on incontinens episodes'; as this is our critical outcome
Not study from NICE guideline
Not study from NICE guideline
Not study from NICE guideline
Wrong study design
Not study from NICE guideline
Wrong study design
Not study from NICE guideline
Not study from NICE guideline
Not study from NICE guideline
Not study from NICE guideline
Not study from NICE guideline
Not study from NICE guideline
Not study from NICE guideline
Not study from NICE guideline
Wrong study design
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Detection bias due to knowledge of the allocated interventions by outcome assessors
Attrition bias due to amount, nature or handling of incomplete outcome data
Reporting bias due to selective outcome reporting
Bias due to problems not covered elsewhere in the table
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
Randomly permuted blocks
Judgement Comment: Participants were randomly assigned within centers tothe ILI or the DSE conditions with equal probability. Randomisation method not desribed.
Women were then randomized to either intervention or control by stratification to UI condition.
Judgement Comment: Randomizationwas performed with the use of randomlypermuted blocks of three or six, stratifiedaccording to clinical center, with random assignmentconcealed in tamper-proof envelopes.Low risk due to stratified randomization
Describe the method used to conceal the allocation sequence in sufficient detail to determine wether intervention allocations could have been foreseen in advance of, during, enrolement.
Concealed tampered entvelopes
Judgement Comment: Not described
Sealed, opaque envelopes numbered consecutively
Judgement Comment: with random assignmentconcealed in tamper-proof envelopes.
Describe all measures used, if any to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Not blinded
Judgement Comment: Patients not blinded due to intervention.
Not blinded
unclear
Describe all measures used, if any to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Patients were aware of their randomazation, but oytcomes assessors were not.
Judgement Comment: Accessors were blinded.
Not blinded
unclear
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
During follow-up, 31 (158 finished) patients in the interventiongroup and 26 (163 fineshed) in controlgroup declined to continue or dropped out.
Judgement Comment: No imputation methods used (110/1385 dropped out in intervention - 145/1354 dropped out in control)
5/24 in the intervention group were excluded from the analysis and 3/24 in the control group were excluded from the analysis due to medical exklusion, lost to follow-up (2 and 2), missing primary outcome and 1 withdrew (control).
Judgement Comment: Attrition is common in weightloss studies; data was imputet by miltuple-imputation methods
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
None detected
Judgement Comment: None of the outcomes used in this substudy are described in the original study with clinicaltrials ID NCT00017953. All relevant outcomes reported.
Presented outcomes reported. No protocol located.
Judgement Comment: All wanted oucomes were presented; protocol published in clin.trials.gov
State any important concerns about bias not addressed in the other domains in the tool. If particular questions/entries were re-specified in the review's protocol, responses should be provided for each question/entry.
None detected
Judgement Comment: None detected;this study is a part of a large series of studies on diabetes.
Nothing detected