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Objective. To assess treatment efficacy and quality of life in women with stress urinary incontinence 3 years after treatment with nonsurgical transurethral radiofrequency collagen denaturation. Methods. This prospective study included 139 women with stress urinary incontinence due to bladder outlet hypermobility. Radiofrequency collagen denaturation was performed using local anesthesia in an office setting. Assessments included incontinence quality of life (I-QOL) and urogenital distress inventory (UDI-6) instruments. Results. In total, 139 women were enrolled and 136 women were treated (mean age, 47 years). At 36 months, intent-to-treat analysis (n = 139) revealed significant improvements in quality of life. Mean I-QOL score improved 17 points from baseline (P = .0004), while mean UDI-6 score improved (decreased) 19 points (P = .0005). Conclusions. Transurethral collagen denaturation is a low-risk, office-based procedure that results in durable quality-of-life improvements in a significant proportion of women for as long as 3 years.

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AIMS: To evaluate 18-month safety and durability of efficacy of nonsurgical transurethral collagen denaturation as treatment for stress urinary incontinence (SUI) in women. METHODS: Study comprised women with SUI due to bladder outlet hypermobility for at least 12 months who failed conservative treatment and had not undergone surgery or bulking agent treatment. This one-time procedure was performed in a physician's office or ambulatory treatment center. Patients kept voiding diaries and completed the Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), and Patient Global Impression of Improvement measures at baseline and at 3, 6, 12, and 18 months posttreatment. RESULTS: At 18 months, intent-to-treat analysis revealed that patients experienced significant reductions in the median number of stress leaks daily (0.43; P < 0.006) and weekly (3.0; P < 0.006) versus baseline, with 46.7% reporting a 50% or greater reduction in leakage. Mean I-QOL score improved 10.9 points (median 8.5; P < 0.0001), with 47.8% having a 10-point or greater improvement and 50.4% reporting improved symptoms versus baseline. Mean UDI-6 improvement was 13.0 points, with a stress incontinence subscore improvement of 17.0 points. Overall, 47.0% of patients were "somewhat" or "very" satisfied, and 52.9% would recommend the procedure to a friend. The procedure was shown to be safe and effective, with no new treatment-related adverse events reported at 18 months. CONCLUSIONS: Transurethral collagen denaturation resulted in significant improvements in stress leaks and quality of life for at least 18 months. This procedure offers a safe, effective, nonsurgical treatment option for women with SUI.

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STUDY OBJECTIVE: To assess efficacy of nonsurgical transurethral collagen denaturation (Renessa) in women with stress urinary incontinence (SUI) caused by bladder outlet hypermobility. DESIGN: Continuing, prospective, 36-month, open-label, single-arm clinical trial. Twelve-month results from intent-to-treat (ITT) analysis are reported. Canadian Task Force classification II-2. SETTING: Thirteen physician offices or ambulatory treatment centers. PATIENTS: Women with SUI secondary to bladder outlet hypermobility for 12 months or longer who failed earlier conservative treatment and had not received earlier surgical or bulking agent therapy. INTERVENTIONS: Women were treated as outpatients and received an oral antibiotic and local periurethral anesthesia before undergoing treatment with transurethral radiofrequency collagen denaturation. MEASUREMENTS AND MAIN RESULTS: Voiding diaries and in-office stress pad weight tests yield objective assessments. Subjective measures include the Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), and Patient Global Impression of Improvement (PGI-I) instruments. In total, 136 women received treatment (ITT population). Patients experienced significant reductions versus baseline in median number of leaks caused by activity/day and activity/week (p <.0026 for both), with 50% of patients reporting 50% or more reduction. Pad weight tests revealed that 69% of women had 50% or more reduction in leakage (median reduction 15.2 g; p <.0001); 45% were dry (29% no leaks; 16% < 1-g leakage). Significant improvements occurred in median scores on the I-QOL (+9.5 [range -66.0 to 91.0]; p <.0001) and mean scores on the UDI-6 (-14.1 +/- 24.7; p <.0001). Furthermore, 71.2% showed I-QOL score improvement, including 50.3% with 10-point or greater improvement, and 49.6% reported on the PGI-I that they were "a little," "much," or "very much" better. CONCLUSION: At 12 months, treatment of SUI with nonsurgical transurethral collagen denaturation resulted in significant improvements in activity-related leaks and quality of life.

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Transurethral radiofrequency collagen denaturation, a nonsurgical treatment for stress urinary incontinence, reduces regional dynamic tissue compliance without causing tissue necrosis or gross tissue shrinkage, unlike transvaginal radiofrequency tissue ablation. This retrospective study evaluated long-term safety and efficacy in 21 patients from a 12-month, randomized controlled trial utilizing 3-day diaries and the Incontinence Quality of Life (I-QOL) survey. Significant increases in overall I-QOL scores 3 years or more post treatment was the primary end point. Secondary end points were reductions in frequency and severity of incontinence episodes. After 3 years, mean overall I-QOL score improvement was 12.7 (+/-26); 56% of patients achieved 50% or more reduction in frequency. No new adverse events occurred. These results indicate that radiofrequency collagen denaturation is safe and provides durable efficacy.

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OBJECTIVE: Clinical trials have demonstrated the safety and efficacy of non-surgical, transurethral radiofrequency (RF) collagen denaturation for treating female stress urinary incontinence (SUI) due to hypermobility. Women in those trials were anesthetized using intravenous conscious sedation. This multicenter trial aimed to demonstrate the feasibility, safety, and efficacy of an oral sedation and local anesthetic regimen in performing RF collagen denaturation. DESIGN AND METHODS: This single-arm study enrolled 33 women, each diagnosed with SUI due to hypermobility, at three United States sites (private physician offices). All women were pretreated with an oral sedative (diazepam) and antibiotic (quinolone) and underwent a bilateral peri-urethral block using 10 cc total of 2% lidocaine. Non-surgical, transurethral RF collagen denaturation was then performed. MAIN OUTCOME MEASURES: The feasibility of the in-office anesthetic regimen was determined based on the number of RF collagen denaturation treatments completed without conversion to intravenous conscious sedation. To assess the patients' subjective level of pain, a visual analog scale (VAS) (0 = no pain; 10 = terrible pain) was completed by each patient immediately before discharge. RESULTS: The in-office anesthetic regimen allowed for treatment completion in all patients (100% feasibility). On the VAS, 42% of the women rated their pain as 0; the mean pain score was 1.4 (SD 1.8). One woman (3% prevalence) experienced two clinically minor adverse events not conclusively related to the anesthetic regimen; both resolved spontaneously without treatment. CONCLUSIONS: The results of this trial were similar to those of larger, sham-controlled studies using intravenous conscious sedation and showed non-surgical RF collagen denaturation to be feasible, safe, and effective when performed using in-office anesthesia.

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AIMS: This prospective, randomized, controlled clinical trial was performed to demonstrate the 12 months safety and efficacy of transurethral radiofrequency energy (RF) collagen micro-remodeling in women with stress urinary incontinence (SUI). MATERIALS AND METHODS: Women with SUI, bladder outlet hypermobility, and leak point pressure (LPP) > or =60 cmH(2)O were randomized to RF micro-remodeling or "sham treatment." Adverse events (AEs) were recorded. Incidence of > or =10 point incontinence quality of life (I-QOL) score improvement, a magnitude of improvement with a demonstrated responsiveness to patient satisfaction with treatment and to > or =25% reduction in both incontinence episode frequency and stress pad weight, served as a subjective outcome measurement. Change in mean LPP served as an objective outcome measurement. RESULTS: 110 women underwent RF micro-remodeling and 63 underwent virtually identical "sham treatment" (with the exception of RF delivery). The 12 months RF micro-remodeling safety profile was statistically no different than that of sham treatment (a brief bladder catheterization). Seventy-four percent of women with moderate to severe baseline SUI experienced > or =10 point I-QOL score improvement at 12 months (P = 0.04). Women who underwent RF micro-remodeling demonstrated LPP elevation at 12 months, while sham treated women demonstrated LPP reduction (P = 0.02). CONCLUSIONS: Non-surgical, transurethral RF micro-remodeling is a safe treatment for women with SUI. In women with moderate to severe SUI, this novel therapy resulted in statistically significant improvement in quality of life of a magnitude associated with patient satisfaction with the treatment. Women who underwent RF micro-remodeling demonstrated a statistically significant elevation in mean LPP at 12 months.

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