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

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Aim The aim of the study was to determine length of time from tension-free vaginal tape procedure to discharge can be shortened by using the infusion method trial of void rather than the standard auto-fill trial of void. Background Tension free vaginal tape (TVT-exact) procedure is a commonly performed continence procedure for urodynamic stress incontinence. At present, prior to discharge home, standard practice at our institution requires completion of a trial of void (TOV). Protocols differ between institutions, but generally a TOV requires overnight admission. However in some centres, it is routine practice to send patients home within 2 hours of the operation if they have passed urine. The nature of the surgery does not require patients to undergo an extended period of observation. Currently, our practice is to empty each patient’s bladder upon completion of surgery. The time to initial void is then dependent on the rate of urine production for each patient. This process is termed “auto-fill”. The alternative method is called the “infusion” method, where the bladder is filled with a predefined volume at completion of surgery to facilitate a shorter time until first postoperative void. The infusion method has been studied in several trials and is safe for patients and effective at predicting which patients will have post-operative voiding dysfunction in gynaecology patients. (Kleeman S, Goldwassar S, Vassallo B. Predicting postoperative voiding efficacy after operation for incontinence and prolapse. Am J Obstet Gynecol 2002;187:49, Pulvino JQ, Duecy EE, Buchsbaum GM, Flynn MK. Comparison of 2 Techniques to Predict Voiding Efficiency After Inpatient Urogynecologic Surgery. J Urol 2010;184:1408) However these studies are not powered to find a significant difference in time to complete TOV. The TOV process will begin in the recovery area of theatre. If the patient passes the TOV within 2 hours and they are otherwise well, they will be discharged home from recovery. If they have not passed their TOV within 2 hours, they will be transferred to the ward for continuation of the process. Recovery and ward nurses assessing the TOVs will be blinded as to which group the patient belongs to. Unlike previous studies, patients will also be blinded as to which group they have been allocated to. Inclusion Criteria Patients consented to undergo a TVT-exact procedure at Robina Hospital. Exclusion Criteria Patients with urodynamic study proven detrusor overactivity, mixed urinary incontinence or voiding dysfunction. Preoperative postvoid residual of >150ml Patients who cannot be booked as a day case i.e. patients with a medical or social reason preventing discharge on the day of operation. Epidural/spinal anaesthesia Neurological conditions affecting the lower urinary tract Bladder perforation at the time of TVT placement or other incidental pathologies diagnosed at time of surgery such as interstitial cystitis, malignancy or calculi. Patients undergoing any other concomitant procedure. Primary Outcome Discharge within 2 hours of the end of the operation. Secondary Outcomes Time taken to complete trial of void Successful trial of void Continued self catheterisation or in-dwelling catheterisation beyond ten days post operation Follow up 1. 2 week gynaecology outpatient appointment to confirm absence of voiding dysfunction: a post void residual with a bladder scanner 2. Routine 6 week postoperative appointment.

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