NCT00984958

Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Skaraborg Hospital · Other Government
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Urinary Stress Incontinence
• Treatment

Interventions

Type	Name	Description
DEVICE	Bulkamid	injection of Bulkamid in the urethra
DEVICE	Bulkamid expectation	expectance

Timeline

• Start date: 2009-10-01
• Primary completion: 2015-07-01
• Completion: 2016-12-01
• First posted: 2009-09-25
• Last updated: 2019-08-30

Locations

1 site across 1 country: Sweden