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
Verified date | August 2019 |
Source | Skaraborg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2016 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Deprtm Ob/Gyn | Skövde |
Lead Sponsor | Collaborator |
---|---|
Skaraborg Hospital |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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