Infusion method vs. standard auto-fill trial of void following a tension free vaginal tape (TVT-exact) procedure in women with urodynamic stress incontinence

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2016
INTERVENTION: After routine surgery instead of emptying bladder and sending patient to ward for trial of void, we will fill bladder with 200ml normal saline (called infusion method) and perform trial of void in recovery. The intervention takes place once the entire surgical procedure is finished. The last part of the procedure is cystoscopy. After the bladder is emptied via the cystoscope, 200ml of normal saline with by infused back into bladder (infusion method). CONDITION: post surgery (midurethral sling procedure) urodynamic stress incontinence PRIMARY OUTCOME: The primary outcome is discharge home from the recovery area. The primary outcome is not the actual time taken to pass trial of void. It is whether the women are discharged home from recovery so we want to know what percentage go home from recovery with each method of trial of void. We want to establish if the infusion method will result in a higher proportion of women going home from recovery. ; Patients who initially fail their trial of void in the 2 hours may go on to pass it on the ward within 24 hours (most do). If they continued to fail their trial of void, they are either sent home with an indwelling catheter or they are taught to self catheterise (more common). Catherisation is continued until bladder function normalises. ; For discharge from recover to be achieved the woman must have successfully passed the trial of void (TOV) ; A successful TOV for the purposes of this trial is defined as follows: ; A SINGLE void of greater than or equal to 2/3 of total bladder volume ; i.e. volume voided/(volume voided + post void residual) is more than 68%. ; ; This will be determined by measuring volume of urine voided and then using a bladder scanner to measure the volume of the post void residual. ; ; ; SECONDARY OUTCOME: Requirement for catheterisation post operatively. successful trial of void (eventually). This is a dichotomous outcome. It is assessed by the formal trial of void process. It requires clinician assessment that voiding is adequate by measuring volume voided with a measuring jug and post void residual with a bladder scanner. If initial trial of void is failed, most clinicians would consider 2 consecutive succsssful voids at defined previously as adequate for a successful trial of void. There is some clinician discretion involved but ultimately it is a question of whether the patient can successful void. time taken to achieve a successful trial of void. ; A successful TOV for the purposes of this trial is defined as follows: ; A SINGLE void of greater than 2/3 of total bladder volume ; i.e. volume voided/(volume voided + post void residual) is more than68%. ; ; This will be determined by measuring volume of urine voided and then using a bladder scanner to measure the volume of the post void residual. ; ; INCLUSION CRITERIA: Any woman consented for a mid urethral sling procedure at Robina Hospital.
Epistemonikos ID: 3cb939e122aa2ea13be266645d0172b71c078df5
First added on: Aug 25, 2024