RecruitingACTRN12608000597392

Prospective Double Blind randomised controlled trial assessing the effects of the cough-test versus no cough-test during the tension free vaginal tape procedure on post operative voiding difficulties.

Prospective Double blind randomised controlled trial assessing the effects of the cough-test versus no cough-test during the tension free vaginal tape procedure on postoperative voiding difficulties.

Sponsor

St George Hospital

Enrollment

142 participants

Start Date

Feb 1, 2006

Study Type

Interventional

Conditions

the TVT- Tension free vaginal tape is a suburethral sling operation for stress incontinence in women.

Summary

The Tension Free Vaginal Tape Procedure (TVT) is the most commonly used procedure for women with stress incontinence worldwide. The cough-test (involving asking the patient to cough during TVT placement until no further leakage is seen) was originally described as being integral to the TVT procedure to improve outcomes and reduce post-operative voiding difficulties. Many gynaecologists now perform TVT insertion without the cough-test claiming similar outcomes, The proposed study is the first randomised trial comparing the differences in post-operative outcome between the TVT performed with an intra-operative cough-test and the same procedure without a cough test

Eligibility

Sex: FemalesMin Age: 21 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for women having a surgical procedure called a Tension Free Vaginal Tape (TVT) to treat stress urinary incontinence — leaking urine when you cough, sneeze, laugh, or exercise. During the TVT procedure, some surgeons ask the patient to cough intraoperatively (during surgery while awake) to help position the tape correctly. This study tests whether doing this cough test actually improves outcomes, such as preventing urine retention after surgery, compared to not doing it. You may be eligible if: - You are a woman aged 21 or older - You have been diagnosed with stress urinary incontinence or mixed incontinence confirmed by urodynamic (bladder function) testing You may NOT be eligible if: - You have previously had a continence procedure (surgery to treat leaking) - You are unable to cough - You are unwilling or unable to give informed consent Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The original tension free vaginal tape procedure was described using a cough test but the test has been abandoned by many. We are studying whether or not this is an important part of the procedure. Both groups undergo the tension free vaginal tape procedure. This involves the insertion of a suburethral tape passed from the vagina and brought out suprapubically attached to 2 needles which are then cut off the tape. The tape then provides support for the urethra when the abdominal and pelvic pressure is raised eg. during coughing or exercise and reduces or completely stops the severity of urine leaked. The intervention group do not receive the cough test. The control group do. The cough test involves waking the patient up after the tape has been passed and asking them to cough. The tape is then adjusted to the surgeons satisfaction allowing a drop of urine to pass but no more during coughing. The intervention group takes approximately 10 to 15 mins less than the control group. The procedure take approximately 30 to 35 mins for the control group.

Locations(1)

Australia

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ACTRN12608000597392