TVT Versus Bulkamid®-Injections in Treatment of Stress Urinary Incontinence
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|ClinicalTrials.gov Identifier: NCT02538991|
Recruitment Status : Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : January 29, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Stress Incontinence||Device: Bulkamid Device: Tension-free Vaginal Tape||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||TVT Versus Bulkamid®-Injections in Treatment of Stress Urinary Incontinence - Patient Satisfaction and Complications of the Treatment|
|Actual Study Start Date :||September 2015|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||December 2022|
Urethral injections will be performed policlinically under local anesthesia (10 ml lidocain, two injections on both sides of the urethra). The Bulkamid-injections will be transurethral four injections (0.2 - 1ml) in locations "ten, two and five and seven o'clock" within 0.5 to 1 cm from the bladder - urethra junction.
Additional injections will be avoided and can be injected only if the first injections fail. After the operation the patient urinates to empty the bladder. The PVR is checked after the treatment with ultrasound simultaneously with evaluation of stability of the Bulkamid-injections. The treatment will be photographed as before and after still pictures for later evaluation.
|Active Comparator: Tension-free Vaginal Tape||
Device: Tension-free Vaginal Tape
TVT will be performed under local anesthesia (70 - 100 ml 0.25% prilocain cum epinephrine) with i.v. pain medication phentanyl two doses and more on request. Operation will be performed with TVT-Exact® kit. Operation can be performed policlinically or in an operation theatre depending on the patient's medical condition. Cystoscopy will be performed after the set of tapes. A cough stress test with 250 to 300 ml bladder fulfillment will show the right tension of the tape. Before the operation a prophylactic antibiotic of Cefuroxime 1.5 g i.v will be given (Dalacin 900 mg i.v in cases of allergy to penicillin). The patient can go home after 2 to 4 hours follow-up, when PVR is under 150 ml. A sick leave of 5 days is recommended.
- Patient satisfaction to treatment [ Time Frame: Up to 5 years after 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).
- Complications of the treatment [ Time Frame: Up to 5 years after treatment ]Possible complications are listed after treatment and on follow-up visits.
- Effectiveness of the treatment in reducing urinary leakage [ Time Frame: Up to 5 years after treatment ]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).
- Cost-effectiveness of the treatment [ Time Frame: Up to 5 years after treatment ]Questionnaires including UDI-6, IIQ-7,RAND-36, PISQ-12
- Pain during and after treatment [ Time Frame: Up to 5 years after treatment ]VAS scale 0-10 used.
- Changes in Quality of Life and symptoms [ Time Frame: Up to 5 years after treatment ]Questionnaires including UDI-6, IIQ-7,RAND-36, PISQ-12
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538991
|Helsinki Women's Hospital|