In a continuing, prospective, 36-month, open-label, single-arm clinical trial, Elser et al (2009) evaluated the effectiveness of non-surgical transurethral collagen denaturation (Renessa) in women with SUI caused by bladder outlet hypermobility. Twelve-month results from intent-to-treat (ITT) analysis were reported. Women with SUI secondary to bladder outlet hypermobility for 12 months or longer who failed earlier conservative treatment and had not received earlier surgical or bulking agent therapy were included in the study. Subjects were treated as out-patients and received an oral antibiotic and local periurethral anesthesia before undergoing Renessa therapy. Voiding diaries and in-office stress pad weight tests yield objective assessments. Subjective measures include the Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), and Patient Global Impression of Improvement (PGI-I) instruments. A total of 136 women received treatment (ITT population). Patients experienced significant reductions versus baseline in median number of leaks caused by activity/day and activity/week (p < 0.0026 for both), with 50 % of patients reporting 50 % or more reduction. Pad weight tests revealed that 69 % of women had 50 % or more reduction in leakage (median reduction 15.2 g; p < 0.0001); 45 % were dry (29 % no leaks; 16 % less than 1-g leakage). Significant improvements occurred in median scores on the I-QOL (+9.5 [range of -66.0 to 91.0]; p < 0.0001) and mean scores on the UDI-6 (-14.1 +/- 24.7; p < 0.0001). Furthermore, 71.2 % showed I-QOL score improvement, including 50.3 % with 10-point or greater improvement, and 49.6 % reported on the PGI-I that they were "a little," "much," or "very much" better. The authors concluded that at 12 months, treatment of SUI with non-surgical transurethral collagen denaturation resulted in significant improvements in activity-related leaks and quality of life.