Table 3: Summary of transurethral radiofrequency collagen denaturation trials.

StudyNAge, yTreatmentStudy designStudy durationEfficacy measuresEfficacy outcomes

Appell et al. 2006 [41]173Mean, 50
Range, 22–76
One-time radiofrequency collagen denaturation ( 𝑛 = 1 1 0 )
Sham procedure ( 𝑛 = 6 3 )
Randomized, sham-controlled, single blind12 mosI-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 = . 0 2

Appell et al. 2007 [40]21Mean, 52.2
Range, 39.0–65.4
One-time radiofrequency collagen denaturationRetrospective follow-up of a 12-month trial36 mosDiaries; I-QOL scoresMean I-QOL scores improved 12.7 points
≥50% decrease in SUI episodes: 56%

Elser et al. 2009 [39]136Mean, 47
Range, 26–87
One-time radiofrequency collagen denaturationOpen label, single arm, interim results12 mosDiaries; 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]136aMean, 47
Range, 26–87
One-time radiofrequency collagen denaturationOpen label, single arm, interim results18 mosDiaries; 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]73b women in a subgroup with baseline moderate to severe SUIN/AOne-time radiofrequency collagen denaturation ( 𝑛 = 4 3 )
Sham procedure ( 𝑛 = 3 0 )
Post hoc analysis of a randomized, sham-controlled, single-blind study12 mosI-QOL scores≥10-point I-QOL improvement:
Treated patients: 74%
Sham: 50%
𝑃 = . 0 3

Sotomayor and Bernal 2005 [37]41Mean, 47.6
Range, 34–81
One-time radiofrequency collagen denaturation, with varying submucosal targets (4 subgroups)Quasirandomized12 mosI-QOL scores; physician-administered questionnaireMean 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.