Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence.

BACKGROUND: Midurethral slings have become the most preferred surgical treatment for female urinary incontinence. OBJECTIVE: To compare the efficacy and safety of two midurethral sling procedures with a different technique of sling insertion 5 yr after intervention. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized clinical trial conducted in seven public hospitals in Finland including primary cases of stress urinary incontinence. INTERVENTION: Surgical treatment with the retropubic tension-free vaginal tape (TVT) procedure or the transobturator tension-free vaginal tape (TVT-O) procedure. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Objective treatment success criteria were a negative stress test, a negative 24-h pad test, and no retreatment for stress incontinence. Patient satisfaction was assessed by condition-specific quality-of-life questionnaires. RESULTS AND LIMITATIONS: A total of 95% of the included women could be assessed according to the protocol 5 yr after surgery. The objective cure rate was 84.7% in the TVT group and 86.2% in the TVT-O group, with no statistical difference between the groups. Subjective treatment satisfaction was 94.2% in the TVT group and 91.7% in the TVT-O group, with no difference between groups. Complication rates were low, with no difference between groups. CONCLUSIONS: Both objective and subjective cure rates were >80% in both groups even when women lost to follow-up were included as failures. The complication rates were low, with no difference between the groups. No late-onset adverse effects of the tape material were seen. PATIENT SUMMARY: Female urinary stress incontinence can be treated surgically with minimally invasive midurethral sling procedures. Two main approaches of sling placement have been developed: the retropubic and the transobturatory. We compared both approaches and followed the patients for 5 yr. We found no difference in cure rate between the procedures, and patient satisfaction was high. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00379314.

Quality of life and costs of levonorgestrel-releasing intrauterine system or hysterectomy in the treatment of menorrhagia: a 10-year randomized controlled trial.

OBJECTIVE: Menorrhagia is a common problem impairing the quality of life (QOL) of many women. Both levonorgestrel-releasing intrauterine system (LNG-IUS) and hysterectomy are effective treatment modalities but no long-term comparative studies of QOL and costs exist. The objective of this study was to compare QOL and costs of LNG-IUS or hysterectomy in the treatment of menorrhagia during 10-year follow-up. STUDY DESIGN: A total of 236 women, aged 35-49 years, referred for menorrhagia to 5 university hospitals in Finland were randomly assigned to treatment with LNG-IUS (n = 119) or hysterectomy (n = 117) and were monitored for 10 years. The main outcome measures were health-related QOL (HRQOL), psychosocial well-being, and cost-effectiveness. RESULTS: A total of 221 (94%) women were followed for 10 years. Although 55 (46%) women assigned to the LNG-IUS subsequently underwent hysterectomy, the overall costs in the LNG-IUS group ($3423) were substantially lower than in the hysterectomy group ($4937). Overall, levels of HRQOL and psychosocial well-being improved during first 5 years but diminished between 5 years and 10 years and the improved HRQOL returned close to the baseline level. There were no significant differences between LNG-IUS and hysterectomy groups. CONCLUSION: Both LNG-IUS and hysterectomy improved HRQOL. The improvement was most striking during the first 5 years. Although many women eventually had hysterectomy, LNG-IUS remained cost-effective.

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on premenstrual symptoms in women treated for menorrhagia: secondary analysis of a randomized controlled trial.

OBJECTIVE: To study the effect of hysterectomy or levonorgestrel-releasing intrauterine system (LNG-IUS) on premenstrual symptoms in women treated for menorrhagia. DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Five university hospitals in Finland. SAMPLE: A cohort of 236 women, aged 35-49 years (mean 43 years) referred for menorrhagia between 1994 and 1997. Women were not diagnosed with premenstrual syndrome. METHODS: Women were randomized to treatment by hysterectomy (n=117) or LNG-IUS (n=119). Analyses were performed using the intention-to-treat and actual treatment principles. Women using estrogen therapy and women who underwent bilateral salpingo-oophorectomy were excluded from the analyses. MAIN OUTCOME MEASURES: The occurrence of premenstrual symptoms evaluated by questionnaires at baseline and at follow-up visits six and 12 months after the treatment and five years after the randomization. RESULTS: Premenstrual symptoms decreased significantly in both groups by six months (p≤0.028) without significant differences between the groups, except that in the LNG-IUS group the decrease of breast tenderness was seen first by 12 months (p=0.048). Even though 42% of the women assigned to treatment with LNG-IUS were hysterectomized during the follow-up period, the results of intention-to-treat and actual treatment analyses were comparable. CONCLUSIONS: Both hysterectomy and LNG-IUS seem to alleviate premenstrual symptoms of women treated for menorrhagia, while the effect of these treatments on premenstrual syndrome remains unsettled.

A randomized trial comparing tension-free vaginal tape with tension-free vaginal tape-obturator: 36-month results.

INTRODUCTION AND HYPOTHESIS: This is a randomized multicenter study comparing two mid-urethra tape procedures, the tension-free vaginal tape (TVT) with the tension-free vaginal tape-obturator (TVT-O) in terms of cure rate and complication rate. METHODS: Seven Finnish hospitals participated. Power calculations required 130 women in each group to detect a 10% difference in cure rate. A total of 267 underwent the allocated operation. Follow-up was scheduled at 2, 12, 36 and 60 months. A cough stress test was used as an objective outcome measure. Subjective outcome was assessed by five different condition-specific quality of life questionnaires. RESULTS: At 36 months of follow-up, 96% of the patients were evaluated. Objective cure rate was 94.6% in the TVT group and 89.5% in the TVT-O group (p = 0.131). Subjective cure rates were significant with no difference between the groups. CONCLUSION: The TVT and the TVT-O are equally effective in the treatment of stress urinary incontinence after 36-month follow-up with no difference in complication rates.

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on lower abdominal pain and back pain among women treated for menorrhagia: a five-year randomized controlled trial.

OBJECTIVE: The purpose of this study was to evaluate the changes in lower abdominal pain and back pain among women with menorrhagia treated by hysterectomy or levonorgestrel-releasing intrauterine system (LNG-IUS). DESIGN: A randomized controlled trial. SETTING: Five university hospitals in Finland. SAMPLE: A total of 236 women, aged 35-49 years. METHODS: Women were randomly assigned to treatment by hysterectomy (n = 117) or LNG-IUS (n = 119). MAIN OUTCOME MEASURES: Frequency and intensity of lower abdominal pain and back pain were evaluated by questionnaires at baseline and after 6 months, 12 months and 5 years. RESULTS: By six months, women in both groups had less frequent back pain than before treatment (p < 0.001). Lower abdominal pain decreased only in the hysterectomy group (p = 0.02) with significant differences between the groups. Between 12 months and 5 years, frequency of lower abdominal pain (p = 0.05) and back pain (p = 0.002) decreased more in the LNG-IUS group than in the hysterectomy group. Between baseline and five years, the lower abdominal pain score (including frequency and intensity of pain) decreased in both groups (p < 0.001, p = 0.01). Back pain score decreased only in the LNG-IUS group and the difference between the groups was significant (p = 0.02). However, some women experienced more pain after both treatments than before treatment. In multivariate analyses, LNG-IUS use was associated with a decrease in lower abdominal pain and back pain. CONCLUSIONS: In the treatment of menorrhagia, both hysterectomy and LNG-IUS decrease lower abdominal pain. LNG-IUS use, but not hysterectomy, has beneficial effects on back pain.

Depressive symptoms as predictors of discontinuation of treatment of menorrhagia by levonorgestrel-releasing intrauterine system.

It has been shown that levonorgestrel-releasing intrauterine system (LNG-IUS) is an effective treatment of menorrhagia. However, the discontinuation rate of LNG-IUS treatment is high, and little is known about the actual reasons intertwining it. We tested the hypothesis that depressive symptoms is the factor responsible for deciding to have a hysterectomy during LNG-IUS treatment. The participants (119 women, ages = 35-49 years) were randomly selected over a 3-year period (1994-1997) to receive the LNG-IUS or a hysterectomy for the treatment of menorrhagia. Depressive symptoms, based on Beck's Depression Inventory measured 6 months after the beginning of the treatment, were related to discontinuation of LNG-IUS use Odds Ratio (OR) = 3.70, 95% Confidence Intervals (CI) 1.55-8.82, p = .003 during a 5-year follow-up. This association was not attenuated after adjustment for other known risk factors. Our findings suggest that diagnosing and treating depression among patients having menstrual problems may improve the continuity of LNG-IUS treatment of menorrhagia.

Retropubic compared with transobturator tape placement in treatment of urinary incontinence: a randomized controlled trial.

OBJECTIVE: To compare the intraoperative and immediate postoperative performance of the retropubic tension-free vaginal tape (TVT) procedure with that of the transobturator tension-free vaginal tape (TVT-O) procedure as primary treatment for female urinary stress incontinence. METHODS: Randomized multicenter comparative trial including four university hospitals and three central hospitals in Finland. Assessment preoperatively and 2 months postoperatively included a cough stress test and the following condition-specific quality of life questionnaires: the Urinary Incontinence Severity Score (UISS), the Detrusor Instability Score, the Incontinence Impact Questionnaire-Short Form, the Urogenital Distress Inventory-Short Form, and a visual analog scale (VAS). Operation time, theater time, hospital stay, intraoperative and immediate postoperative complications were recorded. RESULTS: Of the 273 originally randomized patients, 267 underwent the allocated operation, 136 in the TVT group and 131 in the TVT-O group. No significant differences in objective or subjective cure rates were detected. Patients in the TVT-O group had a significantly longer hospital stay, needed significantly more postoperative opiate analgesia and had significantly more complications than the patients in the TVT group. Patients in both groups had a significant postoperative improvement in quality of life, as indicated by the results of all the questionnaires used, with no difference between the groups. CONCLUSION: The TVT and the TVT-O procedures perform equally in terms of objective and subjective cure. The statistically significant higher complication rate in the TVT-O group is not regarded as clinically significant. CLINICAL TRIAL REGISTRATION: (www.ClinicalTrials.gov), NCT00379314 LEVEL OF EVIDENCE: I.

Tension-free vaginal tape and laparoscopic mesh colposuspension for stress urinary incontinence.

OBJECTIVE: To compare objective and subjective outcomes after the tension-free vaginal tape procedure (TVT) with laparoscopic mesh colposuspension as a primary treatment for female stress urinary incontinence. Objective outcome measures were stress test and 48-hour pad test. METHODS: In 6 departments of gynecology in Finland, including 4 university teaching hospitals and 2 central hospitals, 128 women with urodynamic stress incontinence were randomly allocated to 2 treatment groups. Seventy were treated with TVT and 51 by means of laparoscopic mesh colposuspension. There were 7 dropouts. Inclusion criteria were history of stress incontinence, positive stress test, and urodynamic conformation of stress incontinence. Exclusion criteria were age older than 70 years, previous incontinence surgery, more than 3 episodes of urinary tract infection within the last 2 years, coincident other gynecological surgery, body mass index more than 32 kg/m(2), urethral closure pressure less than 20 cm H(2)O, and residual volume more than 100 mL in preoperative urodynamic evaluation. Assessment took place before treatment and at 12 months postoperatively with the cough stress test, Urge Score, 48-hour pad test, King's College Health Questionnaire, Visual Analog Scale, and Urinary Incontinence Severity Score. RESULTS: When negative stress test was used as criteria for cure, 85.7% of women in the TVT group and 56.9% in the laparoscopic mesh colposuspension group were objectively cured. Subject satisfaction was significantly better after the TVT procedure than after laparoscopic mesh colposuspension. CONCLUSION: Treatment with TVT results in higher objective and subjective cure rates at 1 year than treatment by means of laparoscopic mesh colposuspension.

Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia: randomized trial 5-year follow-up.

CONTEXT: Because menorrhagia is often a reason for seeking medical attention, it is important to consider outcomes and costs associated with alternative treatment modalities. Both the levonorgestrel-releasing intrauterine system (LNG-IUS) and hysterectomy have proven effective for treatment of menorrhagia but there are no long-term comparative studies measuring cost and quality of life. OBJECTIVE: To compare outcomes, quality-of-life issues, and costs of the LNG-IUS vs hysterectomy in the treatment of menorrhagia. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial conducted between October 1, 1994, and October 6, 2002, and enrolling 236 women (mean [SD] age, 43 [3.4] years) referred to 5 university hospitals in Finland for complaints of menorrhagia. INTERVENTIONS: Participants were randomly assigned to treatment with the LNG-IUS (n = 119) or hysterectomy (n = 117) and were monitored for 5 years. MAIN OUTCOME MEASURES: Health-related quality of life (HRQL) as measured by the 5-Dimensional EuroQol and the RAND 36-Item Short-Form Health Survey, other measures of psychosocial well-being (anxiety, depression, and sexual function), and costs. RESULTS: After 5 years of follow-up, 232 women (99%) were analyzed for the primary outcomes. The 2 groups did not differ substantially in terms of HRQL or psychosocial well-being. Although 50 (42%) of the women assigned to the LNG-IUS group eventually underwent hysterectomy, the discounted direct and indirect costs in the LNG-IUS group (2817 dollars [95% confidence interval, 2222 dollars-3530 dollars] per participant) remained substantially lower than in the hysterectomy group (4660 dollars [95% confidence interval, 4014 dollars-5180 dollars]). Satisfaction with treatment was similar in both groups. CONCLUSIONS: By providing improvement in HRQL at relatively low cost, the LNG-IUS may offer a wider availability of choices for the patient and may decrease costs due to interventions involving surgery.

Levonorgestrel-releasing intrauterine system or hysterectomy in the treatment of essential menorrhagia: predictors of outcome.

Levonorgestrel-releasing intrauterine system (LNG-IUS) has been advocated as an effective alternative to hysterectomy in the treatment of menorrhagia. The outcome predictors have been poorly known. In this study the amount of menstrual blood loss (MBL) turned out to be the single most important outcome predictor of these treatments. However, the treatment with LNG-IUS seemed to be an appropriate alternative to hysterectomy for all women who perceived their MBL heavy.

Tension-free vaginal tape and laparoscopic mesh colposuspension in the treatment of stress urinary incontinence: immediate outcome and complications--a randomized clinical trial.

BACKGROUND: The purpose of the study was to evaluate the immediate outcome and complications of the tension-free vaginal tape (TVT) and laparoscopic mesh colposuspension (LC) procedures in the treatment of female stress urinary incontinence (SUI). METHODS: One hundred and twenty-eight patients suffering from urodynamically confirmed SUI were recruited to this multicenter, randomized clinical trial. After randomization there were seven drop-outs--121 patients were operated upon: 70 patients in the TVT group and 51 in the LC group. The patients were evaluated according to the study protocol before operation and 6 weeks after it. The independent sample t-test and the Mann-Whitney U-test were used to calculate statistical differences between the study groups. RESULTS: Immediate cure rates, defined as negative stress test with 300 mL saline in the bladder, were similar (92.9% in the TVT group and 88.2% in the LC group; p = ns). Return to normal voiding was faster in the TVT group (9.2 h in the TVT group vs. 24.4 h in the LC group; p = 0.004). Fewer analgesics were used in the TVT group and hospital stay was shorter in this group. Complication rates associated with the procedures were similar and the number of complications was small. CONCLUSIONS: The immediate outcome of both procedures is the same. The rates of complications were similar. However, the TVT procedure seems to be less invasive and requires fewer hospital resources than LC.