Four-year functional results of the suburethral sling procedure for stress urinary incontinence: a French prospective randomized multicentre study comparing the retropubic and transobturator routes.

PURPOSE: To evaluate long-term (over 4 years) functional outcomes and quality of life of transobturator (TOR) and retropubic (RPR) routes in the cure of stress urinary incontinence (SUI). METHODS: Prospective, randomized multicentre study involving 88 women with SUI from March 2004 to May 2005 (RPR group (n = 42), TOR group (n = 46)). Long-term functional results and quality of life were evaluated using validated questionnaires and compared with those observed at the first year. RESULTS: Eight patients (19%) in the RPR group and 9 patients (19.5%) in the TOR group were lost to follow-up (NS). The mean follow-up in the RPR and the TOR groups was 52.7 months and 53.1 months, respectively. In intention to treat, the success rate at 4 years was 64.3% in the RPR group and 69.5% in the TOR group (NS). At 4 years, no significant differences in the IIQ scores were observed in either group compared to the preoperative scores with no difference between the groups (RPR group: 32 vs. 14.9 (NS), TOR group: 25.7 vs. 21.4 (NS)). Compared to 1 year UDIQ and IIQ scores, a decrease in quality of life was observed for both groups at 4 years (RPR group: 4.7 vs. 34 (P < 0.0001) and 2.6 vs. 14.9 (P < 0.001), TOR group: 1.2 vs. 38.7 (P < 0.0001) and 0 vs. 21.4 (P < 0.0001)) without difference between the groups. CONCLUSIONS: This study shows similar relatively high long-term success rates for both the RPR and TOR procedures. Patients should be informed about a possible time-dependent alteration in functional results.

I-STOP TOMS transobturator male sling, a minimally invasive treatment for post-prostatectomy incontinence: continence improvement and tolerability.

OBJECTIVE: To prospectively evaluate the efficacy and tolerability of the I-STOP TOMS transobturator male sling in patients with post-prostatectomy stress urinary incontinence. Minimally invasive techniques, such as slings, are becoming the standard of care for mild to moderate post-prostatectomy incontinence. METHODS: From March 2007 to June 2009, 122 patients with post-prostatectomy stress urinary incontinence were treated with the I-STOP TOMS sling and followed up for 1 year in the Phase IV HOMme INContinence trial. The preoperative and postoperative evaluation included daily pad use, pad test, questionnaires evaluating urinary function and bother (University of California, Los Angeles, Prostate Cancer Index--urinary function short form, and International Consultation on Incontinence Modular Questionnaire--urinary incontinence short form) and uroflowmetry, including the post-void residual urine volume. Patient satisfaction and perineal pain were also assessed. RESULTS: A total of 103 patients were followed up for 12 months. The surgical procedure was considered easy to perform. The mean daily pad use decreased significantly from 2.4 to 0.6 at 12 months of follow-up; 87.0% of the patients reported improved continence (59.4% completely dry, 20.3% 1 pad/d, 7.3%>1 pad/d), and 13.0% reported no improvement. All quality-of-life scores (University of California, Los Angeles, Prostate Cancer Index--urinary function short form, and International Consultation on Incontinence Modular Questionnaire--urinary incontinence short form) improved significantly after sling implantation. Treatment satisfaction was >90%. The post-void residual urine volume did not increase substantially, and acute urinary retention did not occur. The perineal pain scores were very low at follow-up. Wound infection was seen in 2 patients at the 1-month follow-up visit. CONCLUSION: The I-STOP TOMS is a good treatment option for patients with post-prostatectomy stress urinary incontinence. With follow-up≤12 months, most patients were continent or had improved continence. The intervention was well tolerated, with few infections.

Transobturator male sling TOMS for the treatment of stress post-prostatectomy incontinence, initial experience and results with one year's experience.

PURPOSE: Post-prostatectomy incontinence remains a problem, even in minor or moderate degrees. In order to minimize surgical morbidity and costs, sling procedures have been proposed. The authors have developed a new transobturator male sling procedure and report their results after one-year experience. MATERIALS AND METHODS: A prospective multicenter study was conducted in 50 patients with minor or moderate post-prostatectomy incontinence. Evaluation of TOMS two arms bulbar sling was based on clinical form assessment, The International Consultation on Incontinence Questionnaire (ICIQ) and short-form (SF) 36 questionnaire pre and postoperatively and at 3, 6, 9 and 12 months. RESULTS: The surgical procedure was considered easy to perform and no post-surgery complication was reported except for one retention. The median number of pads per day decreased significantly from 2 pads before surgery (95% CI: 2 - 3) to 1 during the follow-up period (95% CI: 0 - 2 at 360 days), and at 3 months patients using none or one pad per day were 30% and 32% respectively. The SF 36 continence and quality of life score improved from a median of 100 (95% CI: 83 - 133) to 300 (95% CI: 167 - 375), and the median ICIQ incontinence and quality of life score decreased from 15 (95% CI: 14 - 16) to 8 (95% CI: 5 - 12) one year after surgery. CONCLUSION: The transobturator perineal male sling TOMS is an attractive simple sling technique for moderate or minor post-prostatectomy stress incontinence and offers an improvement in the quality of life.

Transobturator male sling TOMS™ for the treatment of stress post-prostatectomy incontinence, initial experience and results with one year's experience

Purpose: Post-prostatectomy incontinence remains a problem, even in minor or moderate degrees. In order to minimize surgical morbidity and costs, sling procedures have been proposed. The authors have developed a new transobturator male sling procedure and report their results after one-year experience. Materials and methods: A prospective multicenter study was conducted in 50 patients with minor or moderate post-prostatectomy incontinence. Evaluation of TOMS™ two arms bulbar sling was based on clinical form assessment, The International Consultation on Incontinence Questionnaire (ICIQ) and short-form (SF) 36 questionnaire pre and postoperatively and at 3, 6, 9 and 12 months. Results: The surgical procedure was considered easy to perform and no post-surgery complication was reported except for one retention. The median number of pads per day decreased significantly from 2 pads before surgery (95 percent CI: 2 - 3) to 1 during the follow-up period (95 percent CI: 0 - 2 at 360 days), and at 3 months patients using none or one pad per day were 30 percent and 32 percent respectively. The SF 36 continence and quality of life score improved from a median of 100 (95 percent CI: 83 - 133) to 300 (95 percent CI: 167 - 375), and the median ICIQ incontinence and quality of life score decreased from 15 (95 percent CI: 14 - 16) to 8 (95 percent CI: 5 - 12) one year after surgery. Conclusion: The transobturator perineal male sling TOMS™ is an attractive simple sling technique for moderate or minor post-prostatectomy stress incontinence and offers an improvement in the quality of life.

Functional results after the suburethral sling procedure for urinary stress incontinence: a prospective randomized multicentre study comparing the retropubic and transobturator routes.

OBJECTIVES: To compare short-term functional outcomes, urodynamic parameters, and quality of life of transobturator and retropubic routes in the cure of urinary stress incontinence. POPULATION AND METHODS: This prospective, multicentre study involved 88 women undergoing suburethral sling procedure for stress urinary incontinence (SUI). The retropubic route (RPR) and the transobturator route (TOR) were used in 42 and 46 women, respectively. No difference in epidemiologic and preoperative urinary functional status (SUI stage, and pollakiuria, nocturia, and urgency rates) was found between the groups. Functional results and quality of life were evaluated before surgery and at 1, 3, 6, and 12 mo postoperatively. Urodynamic examinations were performed before and 3 mo after surgery. RESULTS: The mean follow-up was 10 mo. No difference in the rate of de novo urge incontinence and immediate and late voiding dysfunction was noted between the groups. No difference in the cure rate was observed between the groups (89.3% in the RPR group and 88.6% in the TOR group). RPR was associated with a significant decrease in maximum urinary flow and an increase in residual urine volume. Quality of life was significantly improved after surgery without difference between the groups. CONCLUSIONS: Retropubic and transobturator routes for treatment of female SUI have similar high cure rates and quality of life improvement. Because of advantages in the rate of complications and postoperative pain previously demonstrated on the same population, the transobturator route appears to be the best option for the treatment of urinary incontinence.

Peri-operative complications and pain after the suburethral sling procedure for urinary stress incontinence: a French prospective randomised multicentre study comparing the retropubic and transobturator routes.

OBJECTIVE: To compare peri-operative complications, pain, and the immediate functional results of the sub-urethral sling procedure for urinary stress incontinence by the retropublic and transobturator routes, using a non-elastic polypropylene sub-urethral sling. PATIENTS AND METHODS: This prospective, multicentre study involved 88 women undergoing the sub-urethral sling procedure for stress urinary incontinence (SUI). The retropubic route (RPR) and the transobturator route (TOR) were used in respectively 42 and 46 cases. The characteristics of the women in the RPR and TOR groups were as follows: mean age (+/-standard deviation) 56.8+/-12 years and 53.4+/-10 years, respectively; mean BMI: 25+/-4 and 26+/-4; mean parity: 2.1+/-0.9 and 2+/-1 children; post-menopausal status: 66.7% and 58.7%; prior surgery for SUI: 7.1% and 6.5%; and prior hysterectomy: 21.4% and 26.1%. None of these characteristics differed significantly between the groups. Likewise, pre-operative urinary functional status (SUI stage, and pollakiuria, nocturia and urgency rates) was similar in the two groups. RESULTS: Mean hospital stay and overall morbidity rate were not significantly different between the RPR and TOR groups. Mean operating time was longer in the RPR group. Bladder injury was significantly more frequent in the RPR group and vaginal injury was significantly more frequent in the TOR group. Pain scores were significantly lower in the TOR group. The objective functional results at one month did not differ between the groups. Quality of life, evaluated with questionnaires and numerical rating scales, was similarly improved in the two groups. DISCUSSION: The suburethral sling procedure was less painful by the TOR route than by the RPR route. Bladder injury, haematomas and abscesses were only observed in the RPR group, while vaginal injury only occurred in the TOR group. The immediate functional results of the two approaches were similar.