Halm-Zielke instrumentation for primary stable anterior scoliosis surgery: operative technique and 2-year results in ten consecutive adolescent idiopathic scoliosis patients within a prospective clinical trial

OBJECTIVE: To determine the efficacy and safety of a new continence procedure, tension-free vaginal tape (TVT) placement for surgical treatment of stress urinary incontinence in women. STUDY DESIGN: Eighty-three women with demonstrable stress urinary incontinence underwent a nonrandomized, prospective study using the TVT procedure. The procedure was previously described by Ulmsten et al. In the present study, instead of local anesthesia, epidural blockade with 20 mL of 2% xylocaine was used. Preoperatively the patients were evaluated with a one-hour pad test, full urodynamic testing using either a double-lumen catheter or microtip transducer catheter and were instructed to maintain an one-week baseline urinary diary one week before and two months after the operation. Another one-hour pad test and complete urodynamic evaluation using microtip transducer catheters were offered to 20 patients postoperatively. The period of follow-up ranged from 3 to 18 months. RESULTS: Thirteen women were excluded for various reasons; thus, 70 subjects were enrolled in the study. The urodynamic diagnosis of the 83 women revealed that 71 had genuine stress incontinence, 11 had mixed incontinence and 1 was normal. Mean operation time was 29 minutes (range, 20-51) and mean hospital stay 3 days (range, 2-8). Three bladder perforations occurred intraoperatively. No patients had intraoperative bleeding > 300 mL, but 11 (16%) had blood loss > 200 mL, necessitating an indwelling catheter and vaginal tamponade. No evidence of defect healing or rejection of the tape occurred. Urine leakage observed on the pad test was significantly reduced from a mean of 63 g (range, 10-213) before to a mean of 5 g (range, 0-42) after surgery. The objective cure rate was 83%, and the subjective rate was 87%. CONCLUSION: Although the follow-up period was short, the TVT procedure seemed to be a safe and effective method for the treatment of stress urinary incontinence.