Treatment Clinical Trial
Official title:
Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure Because of Suspected ISD: A Prospective Randomized Study
The aim of this prospective, randomized study of Bulkamid treatment is to investigate the efficacy of Bulkamid treatment in women with urinary stress incontinence not suitable to TVT-procedure because of suspected ISD.
The aim of this prospective, randomized study is to investigate the effect of Bulkamid
injection for women with urinary stress incontinence and not suitable to TVT-procedure
because of suspected ISD and compare this treatment with no or traditional treatment. The
primary endpoint for efficacy will be reduction of leakage during pad-test at 2 months
compared with pad- test before injection.
Secondary endpoints will be patient satisfaction measured at both 2 and 12 months using a
questionnaire and the number of side effects.
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