Status:
COMPLETED
Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure
Lead Sponsor:
Skaraborg Hospital
Conditions:
Urinary Stress Incontinence
Treatment
Eligibility:
FEMALE
50+ years
Phase:
NA
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...
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 a...
Eligibility Criteria
Inclusion
- 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
- Women with hypermobility of the urethra during coughing and positive Bonney's test
- Women suitable for a TVT procedure.
- Positive urinary culture
- Urge incontinence
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00984958
Start Date
October 1 2009
End Date
December 1 2016
Last Update
August 30 2019
Active Locations (1)
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1
Deprtm Ob/Gyn
Skövde, Sweden, SE54185