Obstetrics and Gynecology International Study (year) Design 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 Appell et al. (2006) [19] Randomized sham-controlled trial. Appell et al. (2007) [20] Retrospective followup of 12-month RCT Elser et al. (2009) [21] Prospective single-arm study 136 (ITT) Elser et al. (2010) [22] Prospective single-arm study 136 (ITT) 41 47.6 (34–81) 173 (110 Treated) (63 Sham) 21 (Treated) 50 (22–76) 52.2 (39.0– 65.4) 47.0 (26.0– 87.0) 47.0 (26.0– 87.0) Table 1: Summary of Renessa clinical studies. Patients (number) Mean age Follow-up (range) (months) Measures Outcomes 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. 12 12 36 12 18 I-QOL IEF I-QOL LPP (cm H2O) I-QOL IEF I-QOL IEF UDI-6 PGI-I PWT I-QOL IEF UDI-6 PGI-I 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% 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) I-QOL—mean improvement: 12.7 points IEF—incidence of ≥50% reduction: 56% 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) 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%) 3 Adverse events (% incidence) Urgency (22) Dysuria (8) 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) No new AE’s Dysuria (5.2) Retention (4.4) Pain (2.9) UTI (2.9) Increased leakage (0.7) No new AE’s