NEW YORK (Reuters Health) – Three years after a group of women with stress urinary incontinence were treated with transobturator tension-free vaginal tape (TO-TVT), roughly three-quarters felt the treatment was a success, with no significant differences between the inside-out (TVT-O) and outside-in (TOT) surgical approaches.
However, the patient-reported success rate at three years was lower than at one year, Dr. Mohamed Abdel-fattah from the University of Aberdeen, Scotland and the Evaluation of Transobturator Tapes (E-TOT) study team reports in a paper online now in European Urology.
So far, they haven’t been able to identify any independent risk factor for late failures. In their experience, they say, a repeat midurethral sling “seems an effective surgical option when further continence surgery is required after failed transobturator TVT.”
Results at one year of the randomized controlled E-TOT study, published in BJOG in 2010 and reported by Reuters Health at that time, showed no differences between the two TVT approaches (TVT-O, Ethicon Inc or TOT-Aris, Coloplast Corp) in patient-reported outcomes, objective cure rates, or changes in quality of life and sexual function. (See Reuters Health story April 26, 2010.)
The E-TOT team now reports three-year outcomes for the two types of TO-TVT in 70% of the original cohort (238 of 341). Compared with the one-year follow-up, there was a significant drop in the patient-reported success rate at three years (81.3% vs 73.1%; p=0.005).
Total scores on the King’s Health Questionnaire completed by 216 women (91%) at three years showed a clinically significant improved of 10 points or more in 80.3% of women with no marked difference between the groups.
The Prolapse Incontinence Sexual Function Questionnaire (PISQ-12) was completed by 110 women (46.2%) at three years and compared with preoperative scores, 73.6% had improvement in total scores, whereas 5.5% showed no change and 20.9% showed deterioration.
Twenty-two women needed a second surgery within three years. Eleven had retropubic TVT, seven had TVT-O and four had a rectus fascia sling. Fifteen of these women were “cured” (no symptoms of urodynamic stress incontinence or any other urinary symptoms at three and six months followup and no further relevant hospital records) and three had cure of stress urinary incontinence (confirmed on urodynamic investigation) with residual overactive bladder. Four of the 22 women had ongoing incontinence despite repeat continence surgery.
In an email to Reuters Health, Dr. Abdel-fattah said, “This robust RCT provides, for the first time, reliable evidence for the success rate of both types of transobturator tapes at 3 years follow-up. It has shown that generally transobturator tapes are associated with 73% patient-reported success rate at 3 years, which was significantly lower than the 81% reported at 1-year in the same cohort of women. This information is quite important in informing patient counseling before the operation and for clinicians and decision makers regarding the efficacy of this relatively popular procedure.”
The investigators note in their paper that the lack of an objective assessment for cure is a limitation of the study; “however, the research community is increasingly recognizing that patient-reported outcomes may be more clinically relevant,” they point out.
The E-TOT study was conducted at a single urogynecologic regional referral center in the area, which is another potential limitation. However, five consultant surgeons recruited the patients and did the surgeries; therefore, the authors think the results can be generalized to all surgeons who have completed their learning cure for TO-TOT.
Summing up, Dr. Abdel-fattah said, “Transobturator tapes have been shown to be effective surgical treatment for women with stress urinary incontinence, especially those who have not (had) any previous continence surgery. It is important to note that the majority of women with SUI can be managed conservatively by regular and supervised pelvic floor muscle training (physiotherapy).”