Single Incision Trans-obturator Tape Procedure versus The Standard Trans-obturator Tension-free Tape In The Management of Primary Urodynamic Stress Incontinence

Abstract

The current randomized controlled trial was conducted at Ain Shams University Maternity Hospital during the period between January 2012 and April 2014. Only women with a diagnosis of primary urodynamic stress incontinence, who were adversely impacted from social and hygienic aspects, were recruited in the trial. A total number of 141 women were recruited and were randomized into one of two groups: group I (n=69) planned to undergo single incision TOT procedure, and group II (n=72) planned to undergo standard TOT procedure as the anti-incontinence procedure. A final number of 135 women completed their 6-months follow up, 67 in group I and 68 in group II, and were therefore included in the final analysis. The mean age of included women was 44.2± 7.1 years in group I and 44.1± 8.6 years in group II. The mean BMI was 26.3 ±2.4 kg/m2 in group I and 25.7 ±2.4 kg/m2 in group II. Of the included women in group I, 65.7% were premenopausal, while 66.2% of group II were premenopausal. There were no significant differences between both groups regarding preoperative data or the performance of concomitant procedures. The tapes used were not the commercially-available ready-made tapes. They were self-tailored from a 15x15-cm or 30x30-cm macroporous mono-filamentous type I polypropylene mesh designed for hernioplasty operations. In the current trial, the initial preoperative diagnosis of urodynamic stress incontinence was based on presence of a significant patients' symptom, a positive cough stress test and the urodynamic criteria for the 'genuine' type of stress urinary incontinence. Postoperative cure/failure results of the allocated anti-incontinence procedure were judged through objective (cough stress test) and patient reported outcomes. The current study showed no significant differences between both procedures regarding the objective and subjective cure rates as well as patient satisfaction. The objective cure rate, defined as a negative cough stress test, was 97% for the single incision TOT and 97.1% for the standard TOT procedure 6 months after surgery. The subjective cure rates, defined as absence of episodes of urine leakage, were 88.1% for the single incision TOT and 89.7% for the standard TOT 6 months after surgery. The rates of 'subjectively improved' were 9% for the single incision TOT and 7.4% for the standard TOT at 6 months after surgery. Regarding patient satisfaction, 91% were satisfied after the single incision TOT and 91.2% were satisfied after the standard TOT procedure. The mean operative time was significantly less in the single incision TOT (8.3±2 minutes) compared to the standard TOT (16.5±1.8 minutes). The mean procedure related blood loss was significantly lower in the single incision TOT procedure when compared to the standard TOT procedure (51.5ml vs. 123.1 ml). There was no significant difference between both procedures regarding the overall rate of intra-operative complications. The current trial showed significantly less postoperative pain in women who underwent single incision TOT when compared to those who underwent the standard TOT procedure. Regarding adverse outcomes, 3 patients out of group I and 2 patients out of group II developed de novo voiding difficulty, all resolved on medical treatment (distigmine bromide 5 mg, 1 tablet before breakfast) by 3 months after surgery. There were 5 cases of de novo urge incontinence in group I and 4 cases in group II, all resolved on medical treatment (flavoxate hydrochloride 200 mg, three times daily) by 6 months after surgery. There was one case of vaginal mesh erosion in group I that resolved on local estrogen cream and antibiotics, and 2 cases in group II; one resolved on local estrogen and antibiotic while the other required surgical removal.