Study design. This randomized, prospective study of 164 women who had SUI and ISD (defined as MUCP <20 cm H2O or VLPP <60 cm H2O) randomized subjects to placement of a retropubic sling or a TOT sling. The primary outcome was the presence or absence of urodynamically documented stress incontinence at 6 months. Secondary outcomes included complications, self-reported SUI, and findings on a quality-of-life questionnaire.
Findings. At 6 months, 138 patients completed an evaluation, including repeat urodynamic study. The success rate in the retropubic group was 79%, compared with only 55% in the TOT group (P = .004). Nine women in the TOT group underwent repeat surgery; none did in the retropubic group. There was no difference between groups in de novo overactive bladder symptoms; overactive bladder symptoms resolved at a nearly equivalent rate: 40% in the TOT group and 36% in the retropubic group. No difference was seen in the rate of intraoperative or postoperative complications, although the rate of bladder perforation was higher in the retropubic group, leaning toward significance (P = .06).
WHAT THIS EVIDENCE MEANS FOR PRACTICE
Women who have ISD are better served by having a retropubic sling, not a TOT sling, placed.
Single-incision slings demonstrate lower efficacy than traditional slings
Adbel-Fattah M, Ford JA, Lim CP, Madhuvrata P. Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: a meta-analysis of effectiveness and complications. Eur Urol. 2011;60(3):468–480.
The single-incision sling was introduced in 2006 to, ostensibly, simplify surgery and reduce the risk of complications. Yet, essentially, no data on the efficacy or safety of single-incision kits existed when they entered the market!
Study design. This meta-analysis of single-incision slings analyzed the surgical literature from 1996 through early 2011. Investigators found nine studies that met criteria for objective and subjective outcomes in randomized or quasi-randomized clinical trials. They performed the analysis in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.
A total of 758 women who participated in nine randomized clinical trials were included for analysis. Seven studies reported on the subjective cure rate; six reported on the objective cure rate.
Findings. The analysis showed that single-incision slings are associated with lower subjective and objective cure rates than traditional slings (for single-incision slings, the risk ratio [RR] was 0.83 [95% CI, 0.70–0.99]; for traditional slings, RR was 0.85 [95% CI, 0.74–0.97]). In addition, re-operation rates were significantly higher in the single-incision sling group (RR, 6.72 [95% CI, 2.4–18.9]).
The single-incision sling was associated with a shorter operating time and less postoperative pain, but had a higher rate of mesh exposure (RR, 3.86 [95% CI, 1.45–10.3]).
WHAT THIS EVIDENCE MEANS FOR PRACTICE
This is important information about the relative effectiveness of the single-incision sling compared to more traditional retropubic and TOT approaches. If you are going to offer a single-incision sling, you must 1) select patients carefully and 2) counsel appropriate candidates on two key points: data on the success of single-incision slings are limited and an inferior (that is, inferior to traditional techniques) result is possible.
Stay tuned for more developments in SUI management!
From stem-cell research. This expanding component of a number of medical specialties includes urologic applications. Animal-based studies have been supportive here,1-3 and two studies have translated the use of stem cells for correcting SUI to humans.4,5
Taken together, the human studies treated 20 women with autologous muscle-derived stem cells or muscle progenitor cells that were injected periurethrally or intrasphincterically. Seventeen subjects completed follow-up; improvement was demonstrated in all but two of them.4,5
The promise of stem-cell applications for treating SUI is exciting. We need additional investigation into methods and safety, however—making widespread application in humans not yet suitable. Still, the field is rapidly expanding and this remains a hopeful treatment option for the future.
For repairing vaginal prolapse. Unpublished findings from the Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) trial—the “vaginal counterpart,” one could say, to the notable CARE trial of cholesterol level management—were presented at the annual scientific meeting of the American Urogynecologic Society (AUGS) in September. This landmark study demonstrated that a prophylactic midurethral sling placed at the time of vaginal prolapse repair results in superior continence at 3 and 12 months in women who did not have preoperative symptoms of incontinence. Publication of this study—it has been submitted to a leading medical journal—will have a significant impact on the counseling that providers offer to asymptomatic patients who are undergoing vaginal reconstructive surgery about having a prophylactic sling placed.
REFERENCES
1. Wu G, Song Y, Zheng X, Jiang Z. Adipose-derived stromal cell transplantation for treatment of stress urinary incontinence. Tissue Cell. 2011;43(4):246–253.
2. Kim SO, Na HS, Kwon D, Joo SY, Kim HS, Ahn Y. Bone-marrow-derived mesenchymal stem cell transplantation enhances closing pressure and leak point pressure in a female urinary incontinence rat model. Urol Int. 2011;86(1):110–116.
3. Corcos J, Loutochin O, Campeau L, et al. Bone marrow mesenchymal stromal cell therapy for external urethral sphincter restoration in a rat model of stress urinary incontinence. Neurourol Urodyn. 2011;30(3):447–455.
4. Carr LK, Steele D, Steele S, et al. 1-year follow-up of autologous muscle-derived stem cell injection pilot study to treat stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19(6):881–883.
5. Sebe P, Doucet C, Cornu JN, et al. Intrasphincteric injections of autologous muscular cells in women with refractory stress urinary incontinence: a prospective study. Int Urogynecol J. 2011;22(2):183–189.