DiHA Dextran Copolymer, a new biocompatible material for endoscopic treatment of stress incontinent women, Short term results

BACKGROUND: This study was undertaken to investigate the safety and effect of DiHA, dextranomers in hyaluronan, a new biocompatible material for endoscopic treatment of stress incontinence, and to further develop the injection technique. METHODS: Twenty women aged 38 to 90 years with genuine stress incontinence participated. Seventeen were followed for a minimum of 6 months after treatment and three for a minimum of 3 months. The DiHA implants were administrered by transurethral endoscopically controlled submucosal injections under local anesthesia. Safety was assessed mainly in terms of infection, need for catheterization, residual urine and dysuria. The treatment efficacy was estimated objectively by a short-term pad test with standardized physical exercise and a 48 h pad-test, 7 days, and 1, 3 and 6 months after treatment. The patient's subjective experience of the effect was also studied. RESULTS: The implantation procedure was well accepted by the patients. Four patients required catheterization due to voiding problems during the first 24 postoperative hours. One patient had urinary retention 14 days postoperatively. No UTI or local infection was detected. Some patients had transient urgency. In 17 or 20 patients the treatment resulted in objective cure or improvement. CONCLUSIONS: This substance shows promising qualities for endoscopic treatment of stress incontinence.