Pubovaginal sling versus transurethral Macroplastique for stress urinary incontinence and intrinsic sphincter deficiency: a prospective randomised controlled trial

Abstract

Objective To compare the pubovaginal sling and transurethral Macroplastique in the treatment of female stress urinary incontinence (SUI) and intrinsic sphincter deficiency (ISD). Design A prospective randomised controlled trial comparing two surgical treatments for SUI and ISD.Setting Tertiary referral urogynaecology unit in Australia.Population Women with SUI and ISD who were suitable for either surgical technique.Methods Forty-five women with SUI and ISD were randomly allocated the pubovaginal sling (n ¼ 22) or transurethral Macroplastique (n ¼ 23). Subjective and objective success rates, patient satisfaction and cost measurements at six months and one year following surgery were the primary outcome measures. A telephone questionnaire survey was performed at a mean follow up period of 62 months (43 -71). Main outcome measure Comparison of success rates, complications and costs.Results The symptomatic and patient satisfaction success rates were similar following the sling and Macroplastique with the objective success rate being significantly greater (P < 0.001) following the sling (81% vs 9%). Macroplastique had significantly lower morbidity but was more expensive than the sling (P < 0.001). Response rate at 62 months follow up was 60% in both groups with the sling group reporting better continence success (69% vs 21%) and satisfaction rates (69% vs 29%, P ¼ 0.057). Conclusions The pubovaginal sling was more effective and economical than transurethral Macroplastique for the treatment of SUI and ISD. However, transurethral Macroplastique remains an appropriate treatment in selected cases of SUI and ISD.

The treatment of female stress urinary incontinence: an evidenced-based review

“…The systematic review could not recommend Macroplastique due to insufficient evidence, 35 but three RCTs have been published since that time (Table 1). 16,17,34 In women with urethral hypermobility and SUI, Macroplastique (24 women) had higher cure and improvement rate of 70.8% compared with a pelvic floor exercise program (21 women) 28.5% (P = 0.029). This study did not follow both groups past 3 months and with small treatment groups few definitive conclusions can be drawn.…”

“…[13][14][15][16] However, their success has been reported to be much worse than this when Macroplastique ® (Uroplasty, Minnetonka, MN) and pubovaginal sling were compared with objective cure rates at 6 months being 81% after the sling and only 9% after Macroplastique (P , 0.0001). 17 Other limitations of injectable therapies include their biodegradability and need for retreatment, particularly with collagen (Contigen ® , CRBard, Murray Hill, NJ). The unknown long-term risk of urethral complications as well as the possibility of distant migration and antigenicity of these substances is also of great concern.…”

Recent Developments in the Surgical Management of Urinary Stress Incontinence

“…With regard to the efficacy compared with surgical treatments, two randomized trials should be reviewed. A study by Maher et al [75] compared Macroplastique™ (Uroplasty Inc., Minneapolis, MN) (n = 23) with open pubovaginal sling (n = 22) for women with SUI plus ISD at mean 62-month follow-up. They showed that the satisfaction rates were similar between two groups with the objective success rate being greater (p < 0.001) following the sling (81% vs. 9%).…”

Current trends in the evaluation and management of female urinary incontinence

“…Injection therapy is not as effective as surgery, whether measured in terms of objective cure or improved quality of life; however, it presents fewer risks to the patient. 21,22 Although a recent randomized prospective study showed total 1-year costs of injection therapy to be greater than surgery costs, 23 there are insufficient data on which to base cost comparisons.…”