title: Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 12-month results from a prospective long-term study.
abstract: OBJECTIVE
  To assess efficacy of nonsurgical transurethral collagen denaturation (Renessa) in women with stress urinary incontinence (SUI) caused by bladder outlet hypermobility.
  
  
  METHODS
  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.
  
  
  METHODS
  Thirteen physician offices or ambulatory treatment centers.
  
  
  METHODS
  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.
  
  
  METHODS
  Women were treated as outpatients and received an oral antibiotic and local periurethral anesthesia before undergoing treatment with transurethral radiofrequency collagen denaturation.
  
  
  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.
  
  
  CONCLUSIONS
  At 12 months, treatment of SUI with nonsurgical transurethral collagen denaturation resulted in significant improvements in activity-related leaks and quality of life.
authors.affiliation: Illinois Urogynecology Ltd, Oak Lawn, Illinois, USA. delser@iultd.org
authors.forename: Denise M
authors.initials: DM
authors.lastname: Elser
authors.forename: Gretchen K
authors.initials: GK
authors.lastname: Mitchell
authors.forename: John R
authors.initials: JR
authors.lastname: Miklos
authors.forename: Kevin G
authors.initials: KG
authors.lastname: Nickell
authors.forename: Kevin
authors.initials: K
authors.lastname: Cline
authors.forename: Harvey
authors.initials: H
authors.lastname: Winkler
authors.forename: W Glen
authors.initials: WG
authors.lastname: Wells
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003094:Collagen / Q000528:radiation effects; D003972:Diathermy / Q000379:methods*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D011489:Protein Denaturation; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000628:therapy*; D014550:Urinary Incontinence, Stress / Q000628:therapy*
chemical_list: D003094:Collagen