TVT Versus Bulkamid®-Injections in Treatment of Stress Urinary Incontinence

NAActive, not recruitingINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2024

Conditions
Urinary Stress Incontinence
Interventions
DEVICE

Bulkamid

"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."

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.

Trial Locations (1)

Unknown

Helsinki Women's Hospital, Helsinki

All Listed Sponsors
lead

Helsinki University Central Hospital

OTHER

NCT02538991 - TVT Versus Bulkamid®-Injections in Treatment of Stress Urinary Incontinence | Biotech Hunter | Biotech Hunter