Urinary Stress Incontinence Clinical Trial
Official title:
TVT Versus Bulkamid®-Injections in Treatment of Stress Urinary Incontinence - Patient Satisfaction and Complications of the Treatment
Verified date | March 2024 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
One out of three adult females suffer from daily urinary incontinence. Two thirds of urinary incontinence is physical activity-related stress urinary incontinence (SUI). If the first-line treatment for SUI, training of pelvic floor muscles, is insufficient, treatment options are suburethral sling operation or transurethral bulking injection. Randomized studies between TVT and Bulkamid® and the knowledge about cost-effectiveness and patient satisfaction is missing. This prospective randomized study compares TVT and Bulkamid®-injections in treatment of SUI. Main outcome measures are patient satisfaction, complications and effectiveness of the treatment in reducing urinary leakage. Secondary outcome measures are cost-effectiveness, pain during and after treatment and changes in Quality of Life and symptoms.
Status | Active, not recruiting |
Enrollment | 224 |
Est. completion date | December 2024 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - No previous stress urinary incontinence operation - Positive cough stress test without urge-type urine leakage - Post-void residual urine volume (PVR) <100ml - Urine bladder capacity >3dl in 3-day micturition diary. Exclusion Criteria: - BMI >35 kg/m2 - Neurogenic disease which can be associated with bladder disorders - Use of anticholinergics or mirabegrone - Illness or condition causing even a relative risk for complications in TVT operation (e.g. lower urinary tract anomaly, previous radiation therapy of the pelvis, anticoagulation or haemophilia) - Active malignancy - Current UTI or recurrent UTI (over 3 episodes within the past year) - Urogenital prolapse of more than second degree - Pregnancy or future plans of pregnancy - Inability to understand purpose of the study - Uterine myoma requiring operational treatment - Autoimmune or connective tissue disease contraindicating operation |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki Women's Hospital | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital |
Finland,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient satisfaction to treatment | Patient satisfaction measured on VAS scale of 0 (extremely unsatisfied) to 100 (extremely satisfied). VAS =80 was defined as a good level of satisfaction. Patient satisfaction is measured on follow-up visits (3 months, 1 year, 3 years, 5 years). | Up to 5 years after treatment | |
Primary | Complications of the treatment | Possible complications are listed after treatment and on follow-up visits. | Up to 5 years after treatment | |
Primary | Effectiveness of the treatment in reducing urinary leakage | A stress pad test (Pad weighing after 20 jumping jacks on the spot and three forceful coughs in the standing position with 300 ml bladder volume. To women unable to perform the test it was modified version to 10 coughs in the standing position) performed before treatment and on follow-up visits (3 months, 1 year, 3 years, 5 years). | Up to 5 years after treatment | |
Secondary | Cost-effectiveness of the treatment | Questionnaires including UDI-6, IIQ-7,RAND-36, PISQ-12 | Up to 5 years after treatment | |
Secondary | Pain during and after treatment | VAS scale 0-10 used. | Up to 5 years after treatment | |
Secondary | Changes in Quality of Life and symptoms | Questionnaires including UDI-6, IIQ-7,RAND-36, PISQ-12 | Up to 5 years after treatment |
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