None listed
Conditions
Brief 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
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 press
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.
Sponsors
St George Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients with urodynamic and clinical evidence of mixed or stress incontinence.
Exclusion criteria
Patients who are unwilling or unable to consent to study or who previously underwent a continence procedure. Patients who are unable to cough.
Outcome results
None listed