Perioperative complications and early follow-up with 100 TVT-SECUR procedures.J Minim Invasive Gynecol. 2008 Jul-Aug; 15(4):480-4.JM
Our objective was to evaluate the complications and early follow-up of the tension-free vaginal tape (TVT)-SECUR, a new minimally invasive anti-incontinence operative procedure. A prospective, observational, and consecutive patient series was conducted. Perioperative and 12-month postoperative data were prospectively collected for the first 50 patients against the next consecutive 50 patients, among which TVT-SECUR specific surgical measurements were adopted (Canadian Task Force classification 2). In private hospital operative theatres, the TVT-SECUR operation was performed. Patients with urodynamically proved stress urinary incontinence were enrolled in this study after detailed informed consent was given. The TVT-SECUR, in the hammock shape to mimic the TVT-obturator placement, yet with no skin incisions, required neither bladder catheterization nor intraoperative diagnostic cystoscopy. The clinical and surgical data of 100 consecutive patients with TVT-SECUR were collected prospectively. Two patients had urinary obstructions and needed surgical tape-tension relief. One patient had a 50 mL paravesical self-remitting hematoma. At the first-month postoperative follow-up appointment, the objective therapeutic failure rate for the TVT-SECUR procedure among the 50 patients was 20.0% (10 patients). But when the tape was placed close to the urethra with no space allowed in between, the failure rate in the second patient group went down to 8.0% (4 patients); yet no further postoperative bladder outlet obstruction was diagnosed. Four (8.0%) patients in the first group had vaginal wall penetration with the inserters, requiring withdrawal, reinsertion, and vaginal wall repair. This was avoided with the second patient group by facilitating the inserters' introduction by widening the submucosal tunnel to 12 mm. Six (12.0%) other patients in the first group needed postoperative trimming of a vaginally extruded tape segment, performed in the office with satisfactory results. This problem was addressed later by making the submucosal dissection deeper to avoid intimate proximity of the tape with the vaginal mucosa. Consequently the tape protrusion rate was reduced to 8% (4 patients). Five (10.0%) patients in the first group had unintended tape removal at the time of inserter removal, necessitating the use of a second TVT-SECUR. This was addressed by meticulous detachment of the inserter before its withdrawal, after which no further unintended tape displacements were recorded. No clinical signs for bowel, bladder, or urethral injuries; intraoperative bleeding; or postoperative infections were evident. Telephone interview at the end of 12 months postoperatively was completed with 44 (88.0%) of the first patient group and 46 (92%) of the second patient group. In all, 39 (88.6%) and 43 (93.5%) of the telephone-interviewed patients of the first and second groups, respectively, reported objective urinary continence. The TVT-SECUR, a new midurethral sling, was associated with early safety and efficacy problems. These were identified and rectified, to make the TVT-SECUR a safe and effective anti-incontinence procedure. Operative complications associated with the TVT, such as bladder penetration and postoperative outlet obstruction, and TVT-obturator complications, such as postoperative thigh pain and bladder outlet obstruction, may be reduced with the TVT-SECUR. The first 100 operations' cumulative data analysis yielded some insights, including the necessity of meticulous and proper dissection before placement of the tape and the need for applying minimal extra tension to the tape. However, long-term comparative data collection will be required to draw solid conclusions regarding the appropriate position of this operative technique within the spectrum of anti-incontinence operations.