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

Not Applicable

Completed

• Conditions: Urinary Stress Incontinence; Treatment
• Interventions: Device: Bulkamid; Device: Bulkamid expectation

• Registration Number: NCT00984958
• Lead Sponsor: Skaraborg Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2009-09-24
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Study Start: 2009-10
• Primary Completion: 2015-07
• Study Completion: 2016-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Ability to understand the information and to give informed consent.

• At least 50 years of age
• History of urinary leakage during low grade physical activity. A woman with genuine stress incontinence has urinary incontinence during running or jumping. Women with suspected ISD have incontinence at much lower grade of physical activity such as slow walking or standing up and just coughing. Walking, standing up from a chair, and coughing are regarded as low grade of physical activity.
• A positive pad-test (after coughing 10 times) with increase of minimum of 10 grams of urine with 300 ml in the bladder or a 24 h pad-test of more than 100 mg of urine
• No hypermobility of the urethra during cough test.
• Low pressure of the urethra (optional?)
• With a of average miction volume of minimum 150 ml and at least one volume of more than 250

Exclusion Criteria

• Women with hypermobility of the urethra during coughing and positive Bonney's test
• Women suitable for a TVT procedure.
• Positive urinary culture
• Urge incontinence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bulkamid	Bulkamid	Injection with Bulkamid
expectance	Bulkamid expectation	The expectance arm will after 2 month have the same treatment as the treatment arm

Primary Outcome Measures

Name	Time	Method
After 2 months a scheduled visit with a new pad-test will be performed and the questionnaires UDI-6 (lover urinary tract symptoms) and IIQ-7 (quality of life) will be filled in.	2 month	less intcontines

Secondary Outcome Measures

Name	Time	Method
After 12 months a scheduled visit with new pad-test will be performed and the questionnaires UDI-6 (lover urinary tract symptoms) and IIQ-7 (quality of life) will be filled in.	12 month	less inkontinens

Trial Locations

Locations (1)

Deprtm Ob/Gyn; 🇸🇪 Skövde, Sweden