Results of the 1-year clinical study published in BJU International confirms that polyacrylamide hydrogel is a promising new bulking agent for the treatment of stress urinary incontinence.

The 1-year follow-up article, "A new bulking agent (polyacrylamide hydrogel) for treating stress urinary incontinence in women" by Dr. Gunnar Lose, Dr. Lone Mouritsen and Dr. John Bugge Nielsen has been published in BJU International.

Study objectives

The objectives were to evaluate the efficacy and safety of a transurethral injection with polyacrylamide hydrogel (PAHG) for treating stress urinary incontinence (SUI) in women.

Study design

Between November 2001 and November 2003, 17 women with SUI and 8 with mixed incontinence (urge/stress) age range 35-84 years were injected in the urethral wall with polyacrylamide hydrogel.

Results

4 women did not complete the study, 8 women (38%) were subjectively dry, 9 (43%) improved. Objectively, urine leakage/24h was decreased by 93% and incontinence episodes by 87%. QOL measures improved significantly in all domains other than general health.

Conclusion

"PAHG fulfills many requirements for an optimum urethral bulking agent and this pilot study provides promising clinical results in women with SUI and mixed incontinence."

(BJU International, vol. 98, no. 1, July 2006, p. 100)

For reprints of the article, please contact Birgitte Møller, bm@contura.com.

Based on the experience gained in the clinical study, Contura has optimized the viscosity of its urethral bulking agent. The improved product is marketed under the trade name Bulkamid® along with a proprietary injection device, Bulkamid® Cystoscope. Bulkamid® is CE marked.

Contura has in 2006 initiated a 24 month international multi center study on Bulkamid®.