Prevalence of urinary urgency symptoms decreases by mid-urethral sling procedures for treatment of stress incontinence.

INTRODUCTION AND HYPOTHESIS: Conflicting opinions on the effect of incontinence surgery on the prevalence of postoperative urgency symptoms exists. Our aim was to evaluate the prevalence of urgency symptoms preoperatively and during 3-year of follow-up in women undergoing mid-urethral sling procedures for stress incontinence. METHODS: Two hundred and sixty-seven women were randomly assigned to a retropubic or a transobturator operation. Detrusor instability score (DIS) and Urogenital Distress Inventory-6 (UDI-6) questionnaires were used to assess prevalence of urgency symptoms. The Incontinence Impact Questionnaire-7, visual analog scale, urinary incontinence severity score, and the EuroQol-5D assessed overall quality of life changes. RESULTS: A significant decrease in the DIS and UDI-6 score was seen postoperatively. Signs of de novo urgency symptoms were low. CONCLUSIONS: Mid-urethral sling procedures can be recommended in cases of mixed incontinence, and the procedures seems to decrease prevalence of urgency symptoms.

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.

Dynamic magnetic resonance imaging of the behavior of the mid-urethra in healthy and stress incontinent women.

OBJECTIVES: Support of the mid-urethra is thought to be an essential element of urinary continence in the female. Our aim was to image the behavior of the mid-urethra in healthy volunteers and in stress urinary incontinence (SUI) patients by dynamic magnetic resonance imaging (MRI). DESIGN: Prospective study. SETTING: Gynecology outpatient clinic association with Department of Radiology in University Hospital of Kuopio, Finland. SAMPLE AND METHODS: Fifteen healthy volunteers and 40 SUI women underwent dynamic MRI at rest, during pelvic floor muscle contraction, coughing and voiding with a bladder volume of 200 ml. Our aim was to determine the precise location and movement of the mid-urethra during these activities. MAIN OUTCOME MEASURE: The co-ordinate location and movement of the mid-urethra. RESULTS: Continent volunteers can elevate their mid-urethra significantly higher than incontinent women. Moreover, the mid-urethra of incontinent women rotated significantly more dorsocaudally during straining and coughing than in continent women. CONCLUSIONS: Elevation of the mid-urethra was more marked in continent compared to urinary incontinent women on pelvic floor muscle contraction suggesting sufficient support of the urethra. Downward movement of the mid-urethra was more significant in stress incontinent women than in continent volunteers.

Cost-effectiveness analysis of solifenacin flexible dosing in patients with overactive bladder symptoms in four Nordic countries.

OBJECTIVE: The purpose of the present analysis was to analyze and compare the cost-effectiveness of solifenacin flexible dosing (5-10 mg) with tolterodine 4 mg sustained release (SR) or placebo (assumed to be comparable to no treatment) for patients with overactive bladder (OAB) symptoms. DESIGN: A decision-analytic model was constructed. METHODS: Costs and effects were evaluated for the three treatment options in a one-year timeframe. Costs included were treatment costs, cost of pad use, and patients productivity loss based on data from the Nordic countries. SAMPLE: Results from two randomized controlled trials were used as input data in the cost-effectiveness analysis. MAIN OUTCOME MEASURES: Quality adjusted life years and incremental cost-effectiveness ratio. RESULTS: Solifenacin flexible dosing was more effective with respect to reducing OAB symptoms compared to both placebo and tolterodine 4 mg. Treatment with both solifenacin and tolterodine was more costly compared to placebo, but treatment with solifenacin was a less costly alternative compared to tolterodine 4 mg SR. Sensitivity analyses revealed that the conclusions were robust. CONCLUSION: Solifenacin flexible dosing was a cost-effective treatment alternative compared to tolterodine 4 mg SR.

A randomized trial comparing TVT with TVT-O: 12-month results.

The aim of this randomized clinical trial was to compare the cure rate and the rate of complications of the tension-free vaginal tape (TVT) with those of the tension free vaginal tape obturator (TVT-O) procedure after one year of follow-up. The study was powered to show a ten per cent difference in cure rate and/or rate of complications. Of the initially treated 267 women 134 in the TVT group and 131 in the TVT-O group were evaluated. A cough stress test and a 24 h pad test were used as objective outcome measures. Subjective outcome was assessed by different condition-specific quality of life questionnaires and general health by the EQ-5D questionnaire. Objective cure rate was 95.5% in the TVT patients and 93.1% in TVT-O patients. Subjective cure rates showed significant improvement at one the year follow up in both groups. No significant differences in cure rates between groups were seen. The complication rate was equal in both groups.

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.

Long-term results of the tension-free vaginal tape operation in an unselected group of 129 stress incontinent women.

BACKGROUND: This study was undertaken to examine the long-term effects and effectiveness of the tension-free vaginal tape (TVT) procedure in an unselected group of women. METHOD: One hundred and twenty-nine stress urinary incontinent women (including primary, recurrent, mixed, and low pressure urethra cases) were studied prospectively and examined according to a strict protocol at a mean time of 6 years after their TVT operation. Cough and pad tests were used for objective evaluation, whereas visual analog scale and patients' verbal estimation were applied for subjective evaluation. RESULTS: As assessed by the cough stress test and the pad test, 74 and 81% of the women were totally cured, respectively. Symptoms possibly indicating reduced urine flow were reported from 17% of the women and recurrent urinary tract infections from 9.3% of the women. The de novo urge rate was 4.7%. The tape was visualized in 3.1% of the women and necessitated resection in 1.6% of the cases due to subjective discomfort. No serious or unexpected adverse events were revealed. CONCLUSION: The TVT operation appears to be a safe and effective anti-incontinence procedure in all female stress incontinence subgroups.

A cost-effectiveness analysis of tension-free vaginal tape versus laparoscopic mesh colposuspension for primary female stress incontinence.

BACKGROUND: Evaluation of cost-effectiveness of new surgical techniques is important. As the data on incontinence procedures are scarce, we evaluated the cost-effectiveness of tension-free vaginal tape procedure and laparoscopic mesh colposuspension as a primary surgical treatment for female stress urinary incontinence. METHODS: In four university teaching hospitals and two central hospitals 128 stress incontinent women were randomized to tension-free vaginal tape procedure (n=70) or laparoscopic mesh colposuspension (n=51) in order to investigate the clinical performance of these two procedures. Primary objective clinical outcome measures were: stress test and 48-h pad test. Secondary subjective outcome measures were health-related quality of life measured in terms of visual analogue scale and Urinary Incontinence Severity Score. Alongside the clinical trial, a cost-effectiveness analysis for the main outcome measures was performed. RESULTS: The changes in the 48-h pad test result did not reach statistical significance (p=0.105). When the visual analogue scale or Urinary Incontinence Severity Score are used as the outcome measure, the tension-free vaginal tape is more cost-effective than laparoscopic mesh colposuspension over a follow-up period of one year (p<0.000). CONCLUSION: The clinical and economic data of the present study suggest that over a follow-up period of one year the tension-free vaginal tape procedure is more cost-effective than laparoscopic mesh colposuspension as a primary treatment for female stress urinary incontinence.

Seven-year follow-up of the tension-free vaginal tape procedure for treatment of urinary incontinence.

OBJECTIVE: To evaluate the long-term cure rates and late complication rates after treatment of female urinary stress incontinence with the minimally invasive tension-free vaginal tape operation. METHODS: Prospective observational, 3-center cohort study originally of 90 women requiring surgical treatment for primary urinary stress incontinence. Assessment variables included a 24-hour pad weighing test, a stress test, visual analog scale for assessing the degree of bother, and a questionnaire assessing the subjective perception of the women on their continence status. RESULTS: The follow-up time was a mean of 91 months (range 78-100 months). Both objective and subjective cure rates were 81.3% for the 80 women available for follow-up. Asymptomatic pelvic organ prolapse was found in 7.8%, de novo urge symptoms in 6.3%, and recurrent urinary tract infection in 7.5% of the women. No other long-term adverse effects of the procedure were detected. CONCLUSION: The tension-free vaginal tape procedure for treatment of female urinary stress incontinence is effective over a period of 7 years.

Latest advances in TVT tension-free support for urinary incontinence.

The Tension-free Vaginal Tape (TVT) procedure is the first of a new generation of minimally invasive operations for treatment of female urinary stress incontinence. A new theory of the cause of stress incontinence, the "Mid-urethra Theory," was the basis for development of the TVT operation. Systematic, prospective clinical trials have proved the TVT procedure is effective and safe in curing stress incontinence. Assessed by strict objective and subjective outcome measures, cure rates of 85% were reported, with another 5%-10% being improved significantly. The method is equally effective in groups of patients with uncomplicated genuine stress incontinence, recurrent incontinence, mixed incontinence, and those with intrinsic sphincter deficiency. Careful prospective registering of complications associated with the procedure indicate complication rates are low when proper training is provided and the operation is performed in its standardized method. Five years of follow up show a cure rate of 85%, which indicates little decline in cure rates by time. Preliminary analysis of seven-year results shows a cure rate of 81%.

Tension-free vaginal tape procedure and laparoscopic colposuspension in the treatment of stress urinary incontinence.

PURPOSE OF REVIEW: Within the last decade we have seen substantial development in the surgical techniques used to treat female stress urinary incontinence. The laparoscopic approach became available and even less invasive methods like the tension-free vaginal tape procedure were introduced. RECENT FINDINGS: These procedures offer quicker recovery and faster return to normal activities after surgery compared with the older procedures. The tension-free vaginal tape technique has been extensively studied and clinical data from a significant number of prospective observational cohort studies have been published. The number of reports on laparoscopic incontinence surgery is more limited. Long-term follow-up results with reassuring cure rates at 5 and 7 years are available for the tension-free vaginal tape procedure. Three-year follow-up results for the laparoscopic colposuspension procedure show reasonable cure rates, though not as good as those reported for the open colposuspension, the 'gold standard'. Both of these techniques are now widely used in everyday clinical practice. Perioperative and immediate postoperative complication rates are low and acceptable. However, data are limited in terms of randomized clinical trials comparing these fairly new techniques. SUMMARY: This review attempts to highlight the recent clinical experience of these two surgical techniques, including cure rates, complications and cost-effectiveness.

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.

Tension-free vaginal tape procedure: an effective minimally invasive operation for the treatment of recurrent stress urinary incontinence?

The aim of this study was to evaluate the results of tension-free vaginal tape (TVT) surgery in women with recurrent stress urinary incontinence (SUI). Fifty-one women with recurrent SUI were treated with TVT and followed prospectively for a minimum of 2 years according to a protocol. Twenty percent of the women had already undergone two previous continence procedures, whereas 80% had undergone only one. The mean follow-up period was 25.3 months. The objective cure rate was 89.6%, and the subjective cure rate 80.4%. No serious complications occurred. The majority of the patients were discharged in the afternoon of the operation day. No significant difference was observed between pre- and postoperative residual urine, maximal urethral closure pressure, and total and maximum voided urine volume values. However, the changes in urinary frequency, minimum voided volume, pad test results, and visual analog scale scores were highly significant. TVT appears to be a safe and suitable treatment for recurrent SUI.

A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure.

BACKGROUND: To evaluate the therapy-associated morbidity of all patients who underwent a TVT operation in Finland by the end of the year 1999. METHODS: Questionnaires on the number of operations and on the number of different complications were sent to 38 hospitals where TVT operations had been independently performed after an obligatory TVT training period. The primary TVT training center and a hospital, which did not use the standard TVT equipment, were excluded. RESULTS: Among the 38 hospitals there were four university, 13 central and 21 local hospitals. The total number of operations was 1455. The incidence of bladder perforation was 38/1000, that of intra-operative blood loss over 200 ml 19/1000, of major vessel injury 0.7/1000, of nerve injury 0.7/1000, of vaginal hematoma 0.7/1000 and of urethral lesion 0.7/1000. The incidence of minor voiding difficulty was 76/1000, that of urinary tract infection 41/1000, of complete postoperative urinary retention 23/1000, of retropubic hematoma 19/1000, of wound infection 8/1000 and of vaginal defect healing 7/1000. No case of tape rejection or life threatening complication occurred and the incidence of complications requiring laparotomy was 3.4/1000. The ratio of number of complications to TVT operations performed did not vary significantly between different hospital types (p>0.05). CONCLUSION: The TVT procedure is a safe method for the treatment of stress urinary incontinence provided that appropriate training is offered.