Transurethral Radiofrequency Collagen Denaturation for Treatment of Female Stress Urinary Incontinence: A Review of the Literature and Clinical Recommendations

Table 1

Summary of Renessa clinical studies.

Study (year)	Design	Patients (number)	Mean age (range)	Follow-up (months)	Measures	Outcomes	Adverse events (% incidence)
Sotomayor and Bernal (2005) [18]	Pilot clinical trial with sequential enrollment into 1 of 4 groups based on number of submucosal foci.; Group 1–24; Group 2–36; Group 3–48; Group 4–60	41	47.6; (34–81)	12	I-QOL; IEF	I-QOL—incidence of >10 point score improvement.; Group 1: 63%; Group 2: 44%; Group 3: 70%; Group 4: 67%; Mean scores showed significant improvement for Groups 2–4.; IEF—incidence of ≥50% reduction.; Group 1: 63%; Group 2: 67%; Group 3: 70%; Group 4: 89%	Urgency (22); Dysuria (8)
Appell et al. (2006) [19]	Randomized sham-controlled trial.	173; (110 Treated) (63 Sham)	50; (22–76)	12	I-QOL; LPP (cm H2O)	I-QOL—incidence of ≥10 point score improvement.; Treated: 48%; Sham: 44% (𝑃=0.7); LPP—mean ± SD; Treated: 13.2 ± 39.2; Sham: −2.0 ± 33.8 (𝑃=0.02)	AE (Rx, Sham incidence); Wet OAB (10, 9.5); Dysuria (9.1, 1.6); Dry OAB (7.3, 3.2); UTI (4.5, 4.8); Asymptomatic DO (1.8, 6.3); Retention (0.9, 0); Hematuria (0.9, 0); Hesitancy (0, 1.6)
Appell et al. (2007) [20]	Retrospective followup of 12-month RCT	21; (Treated)	52.2; (39.0–65.4)	36	I-QOL; IEF	I-QOL—mean improvement: 12.7 points; IEF—incidence of ≥50% reduction: 56%	No new AE’s
Elser et al. (2009) [21]	Prospective single-arm study	136; (ITT)	47.0; (26.0–87.0)	12	I-QOL; IEF; UDI-6; PGI-I; PWT	I-QOL—incidence of ≥10 point score improvement: 50.3%; Mean scores showed significant improvement (𝑃<0.0001); IEF—incidence of ≥50% reduction: 50%; UDI-6—mean scores showed significant improvement (𝑃<0.0001); PGI-I—improvement: 49.6% (“very much” 14.4%, “much” 14.4%, “a little” 20.8%); PWT—≥50% reduction: 69% (45% < 1 gram)	Dysuria (5.2); Retention (4.4); Pain (2.9); UTI (2.9); Increased leakage (0.7)
Elser et al. (2010) [22]	Prospective single-arm study	136 (ITT)	47.0; (26.0–87.0)	18	I-QOL; IEF; UDI-6; PGI-I	I-QOL—incidence of ≥10 point score improvement: 47.8%; Mean scores showed significant improvement (𝑃<0.0001); IEF—incidence of ≥50% reduction: 46.7%; UDI-6—mean scores showed significant improvement (𝑃<0.0001); PGI-I—improvement: 50.4% (“very much” 9.6%, “much” 15.2%, “a little” 25.6%)	No new AE’s

I-QOL: Incontinence quality of life instrument, IEF: incontinence episode frequency, LPP: leak point pressure, SD: standard deviation, Rx: treated group, AE: adverse event, OAB: overactive bladder, UTI: urinary tract infection, DO: detrusor overactivity, RCT: randomized controlled trial, UDI-6: urogenital distress inventory, PGI-I: patient global impression of improvement, PWT: pad weight test, and ITT: intent to treat.