Carl Gustaf Nilsson

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.

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. LEVEL OF EVIDENCE: II-3

Updated Systematic Review and Meta-Analysis of the Comparative Data on Colposuspensions, Pubovaginal Slings, and Midurethral Tapes in the Surgical Treatment of Female Stress Urinary Incontinence

CONTEXT Burch colposuspension, pubovaginal sling, and midurethral retropubic tape (RT) and transobturator tape (TOT) have been the most popular surgical treatments for female stress urinary incontinence (SUI). Several randomized controlled trials (RCTs) have been published comparing the different techniques, with conflicting results. OBJECTIVE Our aim was to evaluate the efficacy, complication, and reoperation rates of midurethral tapes compared with other surgical treatments for female SUI. EVIDENCE ACQUISITION A systematic review of the literature was performed using the Medline, Embase, Scopus, Web of Science databases, and Cochrane Database of Systematic Reviews. EVIDENCE SYNTHESIS Thirty-nine RCTs were identified. Patients receiving midurethral tapes had significantly higher overall (odds ratio [OR]: 0.61; confidence interval [CI]: 0.46-0.82; p=0.00009) and objective (OR: 0.38; CI: 0.25-0.57; p<0.0001) cure rates than those receiving Burch colposuspension, although they had a higher risk of bladder perforations (OR: 4.94; CI: 2.09-11.68; p=0.00003). Patients undergoing midurethral tapes and pubovaginal slings had similar cure rates, although the latter were slightly more likely to experience storage lower urinary tract symptoms (LUTS) (OR: 0.31; CI: 0.10-0.94; p=0.04) and had a higher reoperation rate (OR: 0.31; CI: 0.12-0.82; p=0.02). Patients treated with RT had slightly higher objective cure rates (OR: 0.8;CI: 0.65-0.99; p=0.04) than those treated with TOT; however, subjective cure rates were similar, and patients treated with TOT had a much lower risk of bladder and vaginal perforations (OR: 2.5; CI: 1.75-3.57; p<0.00001), hematoma (OR: 2.62; CI: 1.35-5.08; p=0.005), and storage LUTS (OR: 1.35; CI: 1.05-1.72; p=0.02). Meta-analysis demonstrated similar outcomes for TVT-O (University of Liège, Liège, Wallonia, Belgium) and Monarc (AMS, Minnetonka, MN, USA). CONCLUSIONS Patients treated with RT experienced slightly higher continence rates than those treated with Burch colposuspension, but they faced a much higher risk of intraoperative complications. RT and pubovaginal slings were similarly effective, although patients with pubovaginal slings were more likely to experience storage LUTS. The use of RT was followed by objective cure rates slightly higher than TOT, but subjective cure rates were similar. TOT had a lower risk of bladder and vaginal perforations and storage LUTS than RT. The strength of these findings is limited by the heterogeneity of the outcome measures and the short length of follow-up.

The tension-free vaginal tape procedure is successful in the majority of women with indications for surgical treatment of urinary stress incontinence

1546 women) from a population of nearly 1.4 million. It is the biggest published cross sectional survey on this topic that we can find so we are most interested that there are ‘much larger randomised trials’ (none referenced or on any database) with follow up to old age. Of course, by 95 years of age, ‘the obstetric event has to have been one to two decades previously’ or perhaps even more! We have been open and transparent with the data. Although there was a numerical decrease in the prevalence of stress incontinence in women delivered by caesarean section compared with vaginal delivery, this did not reach statistical significance (m 1⁄4 2.8, df 1⁄4 1, P 1⁄4 0.09). A non-significant trend in an observational study is not enough to advocate caesarean section for this reason. However, our study showed that the associated prevalence of all major types of pelvic floor dysfunction after caesarean section was 74% of the prevalence after spontaneous vaginal delivery and 67% of the prevalence following an instrumental delivery. As discussed in the paper, these differences were statistically significant, but clinically, many of the same problems of incontinence and prolapse still occur after caesarean section, and it is highly likely that it is pregnancy and its associated hormones rather than parturition that is the greatest influence on future pelvic floor function. One of us (PDW) is currently analysing the results of a cohort of nearly 8000 women followed for five years after birth and these data will be available soon. Using the above data to calculate the numbers needed for a prospective randomised controlled trial, we have already advocated that there is justification for a ‘term cephalic’ trial. We thank Dr Blanchette for nominating us to organise this trial and for his faith in our longevity. In turn, we nominate him to fund it!

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: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00379314 LEVEL OF EVIDENCE: I

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.

Comparison of a 10-mg controlled release oxybutynin tablet with a 5-mg oxybutynin tablet in urge incontinent patients.

Oxybutynin has long been used for the treatment of patients with detrusor overactivity and urinary urge incontinence. The short half‐life of oxybutynin administered as a conventional tablet formulation or syrup requires 2–3 times daily dosage to be effective. A new controlled release (CR) tablet for once‐daily administration has been developed. The efficacy and tolerability of this new controlled release tablet was compared to that of a 5‐mg conventional oxybutynin tablet administered twice daily. Seventeen female incontinent patients were studied in a double‐dummy crossover trial. Efficacy and tolerability were assessed by using a voiding diary, pad‐weighing test, visual‐analogue scale (VAS), and questionnaire. Adverse events were recorded spontaneously on a questionnaire by the patients themselves throughout the study. Serum concentrations of oxybutynin and its active metabolite N‐desethyloxybutynin were studied after both a single dose and multiple dosage.

Seven-Year Follow-Up of the Tension-Free Vaginal Tape Procedure for Treatment of Urinary Incontinence

adjunct in urinary incontinence surgery since the early 1990s. Those who favor their use cite reduced operating time and a more stable fixed point for suture attachment. Others feel that there is no evidence for improved efficacy, time of surgery or safety. These 2 articles, without recommending or condemning the procedure, call attention to the potential difficulties that can occur. With respect to complications it is unfortunately my opinion that neither the numerator nor the denominator is known. With respect to efficacy there is no objective evidence, in my opinion, that procedures done with bone anchoring are better, worse or the same as those which are not. A chapter on this subject in an evidence based medicine textbook would be very short.

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

Introduction and hypothesisConflicting 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.MethodsTwo 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.ResultsA significant decrease in the DIS and UDI-6 score was seen postoperatively. Signs of de novo urgency symptoms were low.ConclusionsMid-urethral sling procedures can be recommended in cases of mixed incontinence, and the procedures seems to decrease prevalence of urgency symptoms.

Dynamic MRI confirms support of the mid‐urethra by TVT and TVT‐O surgery for stress incontinence

Objective. To study changes in mid‐urethral function with dynamic MRI in stress urinary incontinent women undergoing either tension‐free vaginal tape (TVT) or TVT‐obturator sling operations. Design. Prospective clinical study. Setting. University hospital. Sample. Forty‐two parous women with stress urinary incontinence recruited to dynamic magnetic resonance imaging before and after mid‐urethral sling surgery. Control group of 16 healthy women. Methods. Dynamic magnetic resonance imaging at rest, during pelvic floor muscle contraction, coughing and voiding with a bladder volume of 200–300ml. X‐ and Y‐ coordinates were used to determine the location of the mid‐urethra during these activities. Main Outcome Measures. Changes in mid‐urethral position after TVT and TVT‐obturator operations during the different activities. Results. Postoperatively the women could elevate their mid‐urethra by pelvic floor muscle contraction significantly higher than before the operation (p<0.05). Despite a different support angle between the TVT and the TVT‐O mid‐urethral slings, we could not see any differences in the movement patterns. Conclusion. Mid‐urethral slings support the mid‐urethra and restrict downward movement during different activities. Movement patterns are similar after TVT and TVT‐O operations.