TVT-ABBREVO Versus SERASIS for the Treatment of Female Urinary Stress Incontinence: 1 Year Outcomes of a Comparative Study With 2 Trans-obturator Sub Mid Urethral Slings

Introduction:

The International Uro-gynecological Association (IUGA) and International Continence Society (ICS) defined urinary stress incontinence (USI) as urine loss condition during effort, physical exertion such as sports activities, or while sneezing or coughing1. USI is not a life threatening condition, yet, if left untreated, it might have a significant negative impact on quality of life of many patients. According to epidemiologic studies woman's age, multi-parity and menopausal status are all risk factors for USI1,2.Treatment options offer changes in life style, and nonsurgical modalities such as pelvic floor muscle training which can be useful in mitigating discomforting symptoms. However, upon failure of conservative treatment, surgery will be recommended for women who are unsuccessful in coping with USI3.

Intravaginal sling-plasty retro-pubic surgical procedure was reported by Ulf Ulmsten and Peter Petrous at 1995 for treating urinary stress incontinence4. Soon after, a study was done on this new procedure now called TVT, which was concluded to be a safe and an efficient ambulatory procedure4-6. This led to a major change with the uro-gynecologic operation preferences, based mainly on the open retro-pubic operations before hands. Trans-obturator sub mid urethral tape procedures (TOT) for treating female urinary stress incontinence were reported then-after, first by Delorme 7, then by De Leval 8. The TOT procedures were designed in order to minimize the incidence of some TVT related adverse effects that might severely impede patient's rehabilitation and health, such as urinary tract injuries, urinary outlet obstruction, bowl penetration and intra-operative bleeding9,10. The TOT procedures' efficacy was claimed to be non-inferior to the TVT, therefore became greatly adopted by uro-gynecologists world-wide9. The fact that the TOT needle passes through the medial compartment of the obturator fossa 2.5-3.0 cm to the obturator vessels and nerves, might explain the incidental post-operative thigh pain10.

Despite the fact that TOT is reported to have low complication rates, there are still complaints on post-operative thigh and groin pain as well as dyspareunia11. Study on a mini TVT, a single incision sling that doesn't pass through the obturator membrane, proved reduced post-operative pelvic and thigh pain, yet many surgeons are reluctant to use mini TVT implants because of reduced cure rates. Dyspareunia, however, occurred with TVT, TOT and mini TVT procedures causing concern with sexually active patients11. Thus TOT procedures are frequently performed and thigh and groin pains are constantly a common complications caused by trans-obturator passage of the sling close to the obturator nerve. The typical TOT post-operative pain is at the thigh, uni or bilateral, yet it was described even at the lumbar spine or hip regions. This might have been due to patient's hips position during operation, but more likely to intra-operative obturator nerve injury or post-operative nerve impact, due to a direct pressure or tape foreign body reaction9. Jean De Leval, Alexandre Thomas and David Waltregny proposed a modified TOT, the TVT-Abbrevo (Ethicon J&J Somerville, NJ, USA). The polypropylene tape's length was reduced to 12 cm. The TVT-Abbrevo was developed in order to avoid extensive tape trans-obturator traumatic passage, reduce amount of mesh in the aponeurotic tissues, and this way to reduce the postoperative pain in the thigh and groin areas9. Their results showed that the group underwent modified TVT-Abbrevo procedure experienced less pain on day 0 than the TVT-Obturator group but not thereafter 9,12. In addition to thigh and groin pain, Sue Ross, in his clinical study was concerned to find that an indicative number of women in TOT group had a palpable polypropylene tape at vaginal examination one year after the surgery13. These findings are rather concerning because risk factors for unfavorable outcomes of tape surgeries are not completely understood. It is hard to state whether palpable tapes will lead to erosions or get absorbed into the vaginal tissue that will result in further complications13,14.

The Serasis (Serag-Wiessner, Naila, Germany) was launched for the potential beneficiary impact of especially soft knitted sling implant on the occurrence and severity of post-operative pain. The ratio behind it is the notion that the tape softness will reduce tissue trauma when the tape is introduced through the obturator plat and maybe less fibrotic tissue reaction as well. There are no comparative studies performed on effectiveness of Serasis tape implantation as an anti-USI procedure, neither a comparison against other polypropylene tapes.