Multicenter Prospective Randomized 52-Week Trial of Calcium Hydroxylapatite Versus Bovine Dermal Collagen for Treatment of Stress Urinary Incontinence.

Mayera, R.D., Dmochowskib, R.R., Appellc, R.A., Sandd, P.K.,  Klimberge, I.W., Jacobyf, K.,  Grahamg, C.W., Snyderh, J.A., Nittii, V.W. and Winters, J.C.

The aim of this study was to evaluate the effectiveness and safety of calcium hydroxylapatite (CaHA; Coaptite) injections in comparison to glutaraldehyde cross-linked bovine collagen (Contigen) injections to the urethral sphincter in women with stress urinary incontinence.  This was a large, 12 month prospective, randomised, comparitive, multicentre, single-blind, parallel clinical trial which recruited 296 women with SUI due to intrinsic sphincter deficiency without associated urethral hypermobility.  During the first six months of the trial, up to five injections were performed, and at the 12 month followup, data was available for 231 patients.  The study indicated that both types of injection were well tolerated by the subjects in this study.  There were no systemic adverse effects with either product.  The Stamey Urinary Incontinence Scale was used to grade the improvement in symptoms amongst the subject participants.  At the 12 month follow up, 83 (63.4%) of 131 CaHa patients compared with 57 (57.0%) of 100 collagen patients showed improvement of one Stamey grade or more (P=0.34).  More CaHA patients requried only one injection when compared with the Contigen patients (n=60; 38% compared with n=36; 26.1%; p=0.034) and had a lower total volume of injected material than the Contigen patients through the course of the treatment (4.0mL compared with 6.6mL respectively; P <0.0001).  This study therefore demonstrates that Coaptite is a well tolerated and appropriate treatment for patients with urinary incontinence due to intrinsic sphincter deficiency.

Urology, 69, 5, 876-880

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