Objective Study design ParticipantsTo study the long term results of tension-free vaginal tape, a new ambulatory surgical procedure for treatment of female stress urinary incontinence.A prospective open study using a standardised protocol for pre-and post-operative evaluation.Fifty consecutive women participated in the study. All suffered from genuine stress incontinence. The mean age was 57 years (SD ll), 42 women (84%) were multiparous, 8 (16%) nulliparous.Surgical method Tension-free vaginal tape implies the implantation of a prolene tape around mid-urethra via a minimal vaginal incision. The procedure is carried out under local anaesthesia, allowing the surgeon to check intra-operatively that continence has been obtained.Results All the women except one could be operated on an ambulatory basis under local anaesthesia. Mean operation time was 29 minutes (range 16-47). Ninety percent of the women were able to micturate spontaneously within 24 hours with insignificant residual volumes. In another 10% of the women an in-dwelling catheter had to be used temporarily. There was no need for long term postoperative catheterisation (> 14 days). Post-operative evaluation was carried out after 2 to 6, 12,24 and 36 months. According to the protocol, 86% of the women were completely cured and another 11% were significantly improved. No signs of deterioration of the results over time were observed. No defect in healing or rejection of the tape occurred.Conclusion We consider the tension-free vaginal tape operation to be a safe and effective surgical procedure for the treatment of female urinary stress incontinence. The technique can be considered as an ambulatory procedure performed under local anaesthesia, allowing the majority of the women to be discharged from the clinic the same day or the day after the procedure.

In a prospective long-term Nordic multicenter study, 90 consecutive patients who had a tension-free vaginal tape (TVT) operation performed because of stress urinary incontinence were evaluated according to a strict protocol after approximately 5 years (range 48-70 months). Eighty-five patients could be evaluated according to the protocol. Another 5 elderly patients had to be interviewed by telephone at the final check-up after 5 years. The study protocol involved pre- and postoperative objective and subjective evaluation. The median follow-up time was 56 months. Seventy-two of the 85 patients who were fully evaluated (84.7%) were both objectively and subjectively completely cured. Another 9 patients (10.6%) were significantly improved and 4 (4.7%) were regarded as failures. No patient complained of long-term voiding difficulties and there were no signs of defective healing or rejection of the tape material. All patients had suffered from primary stress incontinence, and 25 also had preoperative complaints of urge. In 14 of these (56%) the urge symptoms were relieved postoperatively. We conclude that the TVT procedure seems to fulfil the expectations of high long-term cure rates, as suggested in previous short-term reports.

The aim of this study was to evaluate the long-term effectiveness and safety of the tension-free vaginal tape (TVT) procedure. In a Nordic three-center prospective observational cohort study, 90 women with primary stress incontinence had a TVT operation performed in local anesthesia. Assessment included a 24-h pad test, a stress test, physical examination, and a visual analog scale for assessing the degree of bother. Patient's global impression of cure was obtained, and condition specific quality of life questionnaires were used. Seventy-seven percent of the initial cohort of 90 women and 89% of those alive and capable of cooperating were assessed 11.5 years after the TVT operation. Ninety percent of the women had both a negative stress test and a negative pad test being objectively cured. Subjective cure by patients global impression was found in 77%, 20% being improved and only 3% regarded the operation as a failure. No late-onset adverse effects of the operation were found, and no case of tape erosion was seen. The TVT procedure is safe and effective for more than 10 years.

In a prospective long-term study 49 women with stress incontinence and ISD (intrinsic sphincter deficiency) were followed for a mean of 4 years (range 3-5) after TVT operation. Preoperatively all patients underwent urodynamic investigations, quality of life evaluation, a 24-hour pad test and a gynecologic examination to properly verify the incontinence symptoms. The same protocol was used for postoperative evaluation. The mean age of the women was 66 years (+/- 11) and mean parity 2 (range 0-4). A standard TVT operation was performed under local anesthesia. At the postoperative evaluations 36 patients (74%) were completely cured of their incontinence problems. In addition, 6 women (12%) were significantly improved. In 7 patients (14%) no improvement was found. The majority of these not cured patients were >70 years of age and had urethral resting pressure of <10 cmH2O. Few intra- and postoperative complications occurred. It is concluded that TVT can be used for surgical treatment of patients with ISD and stress incontinence. However, older patients (>70 years) with a very low resting urethral pressure and an immobile urethra seem to constitute a risk group where TVT surgery is less successful.

In a prospective long-term study we evaluated the effect of TVT surgery in 80 women suffering from mixed urinary incontinence. Their mean age was 59 +/- 11 years with a mean parity of 2 (range 0-6). Mean follow-up was 4 years (range 3-5). The preoperative evaluation included a 24-hour pad test, quality of life evaluation, gynecologic examination and urodynamic investigations, including simultaneous urethrocystometry. From the patient history 96 patients were initially tentative candidates for TVT operation. Sixteen of these had only minor symptoms and signs of stress incontinence but significant symptoms and signs of detrusor instability, and were not considered suitable for TVT surgery. In the remaining 80 women the urodynamic investigation with filling urethrocystometry demonstrated stress incontinence and urge incontinence concomitant with urethral relaxation and/or 'premature micturition' reflex. At the postoperative long-term follow-up 85% of the patients were completely cured. Another 4% were significantly improved. In 11% of the patients the operation failed. Few intra- or postoperative complications occurred. Based on these results, we conclude that TVT surgery can be used for treatment of female mixed urinary incontinence. A proper urodynamic assessment is recommended before surgery is performed.