Nonsurgical Outpatient Therapies for the Management of Female Stress Urinary Incontinence: Long-Term Effectiveness and Durability

Table 3

Summary of transurethral radiofrequency collagen denaturation trials.

Study	N	Age, y	Treatment	Study design	Study duration	Efficacy measures	Efficacy outcomes
Appell et al. 2006 [41]	173	Mean, 50; Range, 22–76	One-time radiofrequency collagen denaturation (𝑛=110); Sham procedure (𝑛=63)	Randomized, sham-controlled, single blind	12 mos	I-QOL scores; LPP testing	≥10-point I-QOL improvement: Treated patients: 48%; Sham: 44%; Mean LPP: Treated patients: 13.2 ± 39.2 cmH2O increase versus Sham patients: −2.0 ± 33.8 cmH2O; 𝑃=.02
Appell et al. 2007 [40]	21	Mean, 52.2; Range, 39.0–65.4	One-time radiofrequency collagen denaturation	Retrospective follow-up of a 12-month trial	36 mos	Diaries; I-QOL scores	Mean I-QOL scores improved 12.7 points; ≥50% decrease in SUI episodes: 56%
Elser et al. 2009 [39]	136	Mean, 47; Range, 26–87	One-time radiofrequency collagen denaturation	Open label, single arm, interim results	12 mos	Diaries; in-office stress pad weight tests; I-QOL scores; UDI-6 scores; PGI-I scores	≥50% decrease in SUI episodes: 50%; ≥50% reduction in leakage: 69%; 45% of patients were dry; Mean I-QOL scores improved 9.5 points; Mean UDI-6 scores improved 14.1 points; PGI-I “a little,” “much,” or “very much” better: 50%
Elser et al. 2010 [42]	136^a	Mean, 47; Range, 26–87	One-time radiofrequency collagen denaturation	Open label, single arm, interim results	18 mos	Diaries; I-QOL scores; UDI-6 scores; PGI-I scores	≥50% decrease in SUI episodes: 47%; Mean I-QOL scores improved 10.9 points; Mean UDI-6 scores improved 13.0 points; PGI-I “a little,” “much,” or “very much” better: 47%
Lenihan et al. 2005 [38]	73^b women in a subgroup with baseline moderate to severe SUI	N/A	One-time radiofrequency collagen denaturation (𝑛=43); Sham procedure (𝑛=30)	Post hoc analysis of a randomized, sham-controlled, single-blind study	12 mos	I-QOL scores	≥10-point I-QOL improvement: Treated patients: 74%; Sham: 50%; 𝑃=.03
Sotomayor and Bernal 2005 [37]	41	Mean, 47.6; Range, 34–81	One-time radiofrequency collagen denaturation, with varying submucosal targets (4 subgroups)	Quasirandomized	12 mos	I-QOL scores; physician-administered questionnaire	Mean I-QOL scores improved 16–24 points; ≥50% decrease in SUI episodes: 63%–89%; Cured: 22%–67%

Abbreviations: I-QOL, Incontinence Quality of Life questionnaire; LPP, leak point pressure; PGI-I, Patient Global Impression of Improvement; SUI, stress urinary incontinence; UDI-6, Urogenital Distress Inventory.
^aThese patients were already counted in Elser et al. 2009 [39], thus they were not included in the total patient numbers as given in the text.
^bThese patients were already counted in Appell et al. 2006 [41], thus they were not included in the total patient numbers as given in the text.