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A population based, randomized, controlled trial of conservative treatment for urinary incontinence in women
Holtedahl K, Verelst M, Schiefloe A
Acta Obstetricia et Gynecologica Scandinavica 1998 Jul;77(6):671-677
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Urinary incontinence remains a hidden and inadequately treated problem in a high proportion of women. METHODS: Ninety women 50 to 74 years of age were recruited to a population-based, randomized, controlled clinical trial of conservative treatment for urinary incontinence, with delayed treatment for the control group. The study was performed in general practice in three north-Norwegian municipalities, in cooperation with two local departments of gynecology. Three patients were found protocol deviant and analysis was based on 87 patients. INTERVENTION: Local estrogen, physiotherapy and electrostimulation combined with close follow-up. MAIN OUTCOME MEASURES: (1) Change in severity of incontinence from start of treatment (index range 0 to 8). (2) Change in impact from start of treatment (index range 0 to 4). (3) Quantitative measures in relation to micturition. (4) Criteria based classification into cured, improved, unchanged, worse. RESULTS: Treatment reduced severity (index change 1.8 in the intervention group versus 0.1 in the control group at six months) and impact (index change 0.8 versus 0.0) of leakage. Almost one third of the patients did not complete all micturition tests, but in those who did, average number of wet episodes per 24 hours decreased with treatment, and so did average number of micturitions in urge and mixed incontinence. Forty-nine patients (56%) were cured or improved after one year. CONCLUSION: Women 50 to 74 years of age with urinary incontinence may improve considerably through conservative treatment in general practice.

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