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

NCT02538991 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2024-03-26

No results posted yet for this study

Summary

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.

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.

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2022-12-31
Completion
2024-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02538991 on ClinicalTrials.gov