Quality of life after tension-free vaginal tape surgery for female stress incontinence.

OBJECTIVE: To undertake a long-term follow-up evaluation of the quality of life (QOL) of women who had undergone a tension-free vaginal tape (TVT) procedure. MATERIAL AND METHODS: During the period 1995-2001, 970 women with urinary stress incontinence underwent TVT surgery at the Department of Obstetrics and Gynecology, Falun Hospital. A questionnaire was mailed on average 5.7 years after the TVT procedure. Two incontinence-specific QOL instruments--the Incontinence Impact Questionnaire-7 (IIQ-7) and the Urogenital Distress Inventory-6 (UDI-6)--were administered. An additional questionnaire included general questions and questions about chronic diseases that may be associated with urinary incontinence. RESULTS: The mean age at surgery was 58.7 years (range 29-89 years). Of 913 eligible women, 768 (78.9%) responded. Mean IIQ-7 and IDU-6 scores as estimated by the women improved dramatically at follow-up as compared to preoperative values: from 43.7 to 11.5 for the IIQ-7 and from 54.2 to 24.0 for the UDI-6 on a scale from 0 to 100 (p = 0.0001 for both). There were few differences in mean QOL scores even 8 years after TVT surgery, compared to those determined a shorter time after the operation. Women with diabetes, chronic constipation, chronic bronchitis and preoperative recurrent urinary infections had a relative improvement in QOL of the same magnitude as that of the remaining study population. Advanced age was negatively associated with an improvement in QOL scores. CONCLUSIONS: Improvements in measures of QOL after TVT surgery are dramatic and persist for years. Women with concomitant diseases that may be associated with urinary incontinence can be assured that there is a good chance of success with TVT surgery.

The safety and efficacy of MenoTreat, a new balloon device for thermal endometrial ablation.

BACKGROUND: An evaluation of the performance and safety of the prototype of a new device, MemoTreat (Atos Medical) for thermal endometrial balloon ablation in patients with menorrhagia. The evaluation was performed at four Swedish hospitals. METHODS: In total 51 consecutive, premenopausal patients, suffering from menorrhagia due to benign causes and not responding to conventional treatment, were treated between March 1997 and March 1998. The treatment entailed heated (85 degrees C) sterile saline circulated in a uterine balloon at a treatment pressure of 200 mmHg for 11 minutes. The procedure was performed mainly under general anesthesia and no pre-treatment endometrial thinning was performed. A validated pictorial assessment technique was used to evaluate changes in menstrual blood loss before and after treatment. Changes in quality of life and severity of dysmenorrhea were also evaluated. Data analysis was based on the 'intention to treat' method. RESULTS: The success rate in terms of a 50% reduction in menstrual bleeding was 84.3% at 6 months after treatment. Five patients became amenorrheic. The quality of life assessment showed substantial improvement and the severity of dysmenorrhea was markedly reduced. No intra-operative treatment complications occurred and the post-treatment morbidity was similar to that reported for other similar treatment methods. CONCLUSIONS: MenoTreat significantly reduced menstrual bleeding in menorrhagic patients, with a concomitant improvement in quality of life. The findings in this study resulted in a redesigned device with a thinner balloon catheter, improved cervical protection and treatment temperatures kept at a constant level.

A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence.

The aim of the study was to evaluate the safety and efficacy of TVT (tension-free vaginal tape) for the surgical treatment of stress urinary incontinence. The design was a prospective open multicenter study including six centers, each operating an approximately 20 patients. In total 131 patients suffering from genuine stress incontinence were included. They were followed for at least 1 year using a specific protocol for objective and subjective evaluation of the outcome. All patients underwent the operation under local anesthesia. Mean operation time was 28 minutes (range 19-41 minutes); 119 (91%) of the patients were cured according to the protocol and another 9 (7%) were significantly improved. There were 3 (2%) failures. The majority of the patients (about 90%) were operated upon on a day-care basis, which implied that they were released from the hospital within 24 hours, with no postoperative catheterization. No defect healing and no tape rejection occurred. Three patients needed an indwelling catheter for 3 days. In 1 patient catheterization was necessary for more than 10 days. Two uncomplicated hematomas and one uncomplicated bladder perforation occurred. Based on the results, we conclude that TVT is a safe and effective ambulatory procedure for surgical treatment of genuine stress urinary incontinence.