Durability of Urethral Bulking Agent Injection for Female Stress Urinary Incontinence: 2-Year Multicenter Study Results

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

doi:10.1016/j.juro.2009.12.038

« Previous Next »The Journal of Urology
Volume 183, Issue 4 , Pages 1444-1449, April 2010

Durability of Urethral Bulking Agent Injection for Female Stress Urinary Incontinence: 2-Year Multicenter Study Results

Gamal Ghoniem
- Cleveland Clinic Florida, Weston, Florida
- Correspondence: Section of Voiding Dysfunction, Female Urology and Reconstruction, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston, Florida 33331-3609 (telephone: 954-659-5188; FAX: 954-659-5189)
- Financial interest and/or other relationship with Astellas, Uroplasty and Coloplast.
Jacques Corcos
- McGill Urology Associates, Montreal, Quebec, Canada
- Financial interest and/or other relationship with Johnson & Johnson and Astellas.
Craig Comiter
- University of Arizona, Tucson, Arizona
- Financial interest and/or other relationship with Coloplast, Pfizer, Astellas and Johnson & Johnson.
O. Lenaine Westney
- University of Texas, Houston, Texas
- Financial interest and/or other relationship with American Medical Systems and Coloplast.
Sender Herschorn
- University of Toronto, Toronto, Canada
- Financial interest and/or other relationship with Johnson & Johnson and Coloplast.

Received 14 September 2009 published online 22 February 2010.

Purpose

We evaluated the durability of the urethral bulking agent Macroplastique® for stress urinary incontinence in a 24-month study in women with a previously documented successful outcome 12 months after the last injection.

Materials and Methods

In a multicenter study females diagnosed with stress urinary incontinence primarily due to intrinsic sphincter deficiency successfully treated with Macroplastique, defined as 1 or greater Stamey grade improvement 12 months from baseline, were followed for 24 months to assess the sustained therapeutic response. Outcome measures were Stamey grade, Patient Global Impression of Improvement, Physician Assessment of Improvement, 1-hour pad weight, Incontinence Quality of Life scores and safety assessment.

Results

At 24 months 56 of 67 patients (84%) had sustained success since 12 months, of whom 45 of 67 (67%) were dry (Stamey grade 0). Of the dry patients at 12 months 33 of 38 (87%) maintained cure at 24 months. Also, 12 of 29 patients (41%) considered improved at 12 months were dry at 24 months. Overall Incontinence Quality of Life scores and all subscales showed statistically significant improvement from baseline (p <0.001). Mean pad weight was 24 gm at baseline, and 4 gm at 12 and 24 months. Patient and physician assessments rated 85% of patients dry or markedly improved 24 months after the last treatment.

Conclusions

Substantial, durable results were sustained during 2 years with 84% of patients maintaining significant Stamey grade improvement from the 12-month assessment. Two-thirds of patients were dry at 24 months. The durability of Macroplastique shows its effectiveness as a viable long-term therapy for female stress urinary incontinence primarily due to intrinsic sphincter deficiency.

Key Words: urethra, silicone elastomers, urinary incontinence, stress, injections

Abbreviations and Acronyms: I-QOL, Incontinence QOL, ISD, intrinsic sphincter deficiency, QOL, quality of life, SUI, stress urinary incontinence, UBA, urethral bulking agent