UROLOGICAL SURVEY   ( Download pdf )

 

NEUROUROLOGY & FEMALE UROLOGY

Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 12-month results from a prospective long-term study
Elser DM, Mitchell GK, Miklos JR, Nickell KG, Cline K, Winkler H, Wells WG
Illinois Urogynecology Ltd, Oak Lawn, Illinois, USA
J Minim Invasive Gynecol. 2009; 16: 56-62

  • 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.

  • Editorial Comment
    Authors report on the therapy of female stress urinary incontinence using transurethral radiofrequency (RF) collagen denaturation. This report entails the 12-month results from an ongoing 36-month intent to treat study. The authors identified the following: no significant adverse events; that the procedure was very well tolerated; and using this minimally invasive technique, results similar to transurethral bulking agents were obtained.
    This review revisits a new technology which has been previously surveyed in this journal (1). In that study, the authors noted the safety of the therapy as well as its clinical efficacy when reported in comparison to a sham treatment. Though the study did report a significant number of patients who were lost to follow-up, withdrew consent, or opted for surgery, this is not unexpected in view of the large number of study centers (13 centers) which were incorporated into the study. Of note is that the procedure appears to be very safe, very fast and highly competitive with bulking therapy in the patient with urethral hypermobility. This refined application of the radiofrequency energy to alter collagen is distinctly different from the ablative therapy used for neoplastic conditions or benign gynecological diagnoses. Though the therapy does not appear to preclude further surgery, it should be avoided in patients who already have injectable therapy secondary to potentially variable application of the energy to the periurethral implant. That this technology may be applied in the office with the use of a local periurethral anesthetic and has a very short post-procedure convalescence period renders it a therapeutic option that warrants a close review by treating physicians.

Reference
1. Petrou SP: Editorial Comment (On: Appell RA, Juma S, Wells WG, Lenihan JP, Klimberg IW, Kanellos A, Reilley SF: Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence. Neurourol Urodyn. 2006; 25: 331-6.). Int Braz J Urol. 2006; 32: 739-40.

Dr. Steven P. Petrou
Professor of Urology, Associate Dean
Mayo School of Graduate Medical Education
Jacksonville, Florida, USA
E-mail: petrou.steven@mayo.edu