Obstetrics and Gynecology International / 2012 / Article / Tab 1

Review Article

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)DesignPatients (number)Mean age (range)Follow-up (months)MeasuresOutcomesAdverse 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
4147.6
(34–81)
12I-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)
12I-QOL
LPP (cm H2O)
I-QOL—incidence of ≥10 point score improvement.
Treated: 48%
Sham: 44% ( )
LPP—mean ± SD
Treated: 13.2 ± 39.2
Sham: −2.0 ± 33.8 ( )
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)

Appell et al. (2007) [20]Retrospective followup of 12-month RCT21
(Treated)
52.2
(39.0–65.4)
36I-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 study136
(ITT)
47.0
(26.0–87.0)
12I-QOL
IEF
UDI-6
PGI-I
PWT
I-QOL—incidence of ≥10 point score improvement: 50.3%
Mean scores showed significant improvement ( )
IEF—incidence of ≥50% reduction: 50%
UDI-6—mean scores showed significant improvement ( )
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 study136 (ITT)47.0
(26.0–87.0)
18I-QOL
IEF
UDI-6
PGI-I
I-QOL—incidence of ≥10 point score improvement: 47.8%
Mean scores showed significant improvement ( )
IEF—incidence of ≥50% reduction: 46.7%
UDI-6—mean scores showed significant improvement ( )
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.