Cross-Linked Polydimethylsiloxane Injection for Female Stress Urinary Incontinence: Results of a Multicenter, Randomized, Controlled, Single-Blind Study

Ghoniem, Gamal; Corcos, Jacques; Comiter, Craig; Bernhard, Peter; Westney, O. Lenaine; Herschorn, Sender

doi:10.1016/j.juro.2008.09.032

« Previous Next »The Journal of Urology
Volume 181, Issue 1 , Pages 204-210, January 2009

Cross-Linked Polydimethylsiloxane Injection for Female Stress Urinary Incontinence: Results of a Multicenter, Randomized, Controlled, Single-Blind Study

Gamal Ghoniem
- Cleveland Clinic Florida, Weston, Florida
- Correspondence: Section of Voiding Dysfunction, Female Urology and Reconstruction, Cleveland Clinic Florida, (telephone: 954-659-5188; FAX: 954-659-5189)
- Financial interest and/or other relationship with Astellas, Coloplast, Uroplasty and Bulkamid.
Jacques Corcos
- McGill Urology Associates, Montreal, Quebec, Canada
- Financial interest and/or other relationship with Johnson&Johnson, Astellas, Purdue, Triton and Allergan.
Craig Comiter
- Stanford University Medical School, Stanford, California
- Financial interest and/or other relationship with Coloplast and Astellas.
Peter Bernhard
- Urology Associates, Minneapolis, Minnesota
O. Lenaine Westney
- University of Texas, Houston, Texas
- Financial interest and/or other relationship with American Medical Systems.
Sender Herschorn
- University of Toronto, Toronto, Ontario, Canada
- Financial interest and/or other relationship with Pfizer, Astellas, Johnson&Johnson, Allergan and Lilly.

Received 19 May 2008 published online 14 November 2008.

Purpose

In a pivotal trial we evaluated the effectiveness and safety of Macroplastique® as minimally invasive endoscopic treatment for female stress urinary incontinence primarily due to intrinsic sphincter deficiency.

Materials and Methods

A total of 247 females with intrinsic sphincter deficiency were randomized 1:1 and treated with a transurethral injection of Macroplastique or Contigen®. The latter group served as the control. Repeat treatment was allowed after the 3-month followup. Effectiveness was determined 12 months after the last treatment using Stamey grade, pad weight and Urinary Incontinence Quality of Life Scale scores. Safety assessment was recorded throughout the study.

Results

After 12 patients were excluded from study 122 patients received Macroplastique injection and 125 received Contigen injection. Mean patient age was 61 years and the average history of incontinence was 11.2 years. Of the patients 24% had undergone prior incontinence surgery. At 12 months after treatment 61.5% of patients who received Macroplastique and 48% of controls had improved 1 Stamey grade. In the Macroplastique group the dry/cure rate was 36.9% compared to 24.8% in the control group (p <0.05). In the Macroplastique and control groups the 1-hour pad weight decrease was 25.4 and 22.8 ml from baseline (p = 0.64), and the mean improvement in Urinary Incontinence Quality of Life Scale score was 28.7 and 26.4 (p = 0.49), respectively.

Conclusions

Macroplastique injection was statistically more effective than Contigen for stress urinary incontinence primarily due to intrinsic sphincter deficiency with a 12.1% cure rate difference. Macroplastique can be administered on an outpatient basis. It should be considered a primary or secondary treatment option for stress urinary incontinence.

Key Words: urethra, urinary incontinence, stress, injections, prostheses and implants, female

Abbreviations and Acronyms: I-QOL, Urinary Incontinence Quality of Life Scale, ISD, intrinsic sphincter injury, SUI, stress urinary incontinence, UBA, urethral bulking agent