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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Urinary Stress Incontinence, Treatment

Intervention / Treatment
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* Device: Bulkamid
* Device: Bulkamid expectation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1 will get treatment and Group 2 will have no treatment for 2 month
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bulkamid<br>Injection with Bulkamid | Device: Bulkamid<br>* injection of Bulkamid in the urethra<br>|
| Other: expectance<br>The expectance arm will after 2 month have the same treatment as the treatment arm | Device: Bulkamid expectation<br>* expectance<br>* Other names: after 2 month the patient can be treated;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | less intcontines | 2 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | less inkontinens | 12 month |