title: Intravesical infusion of resiniferatoxin by a temporary in situ drug delivery system to treat interstitial cystitis: a pilot study.
abstract: OBJECTIVE
  Interstitial cystitis (IC), a syndrome characterized by motor and sensory dysfunction of the lower urinary tract, represents a diagnostic and therapeutic challenge even to highly skilled physicians. We investigated the technical feasibility and the clinical efficacy of a prolonged intravesical instillation of RTX by in situ drug delivery system in patients with IC.
  
  
  METHODS
  5 female patients (mean age 48.7 years) received a prolonged infusion of a saline solution containing 10nM of resiniferatoxin at the flow rate 25microl/h by the MiniMed 407C Infusion Pump (MiniMed Sylmar, CA, USA), connected to sovrapubic 5Fr mono Pigtail catheter, for 10 days. All patients reported frequency, nocturia and urgency, and symptoms of pelvic pain for at least six months. They showed the absence of urinary tract infection within the last three months, the absence of functional disorders of lower urinary tract and no other vesical or urethral pathology. The pre-treatment (PT) frequency/volume (FV) chart and a pain score (VAS score) were recorded. Patients were evaluated after 30 days from the end of infusion (primary end point, PEP) and after three months (secondary end point, SEP).
  
  
  RESULTS
  At PEP frequency reduced from 11.3+/-1.39 to 7.4+/-1.51 (p<0.01) and nocturia from 3.6+/-0.54 to 1.2+/-0.44 (p<0.01). A highly significant reduction of pain score was observed at PEP: it decreased to 2.4+/-0.54 from 6.7+/-0.83 (p<0.01). The pain score remained significantly lower at SEP (3.2+/-0.44 p<0.05). Nocturia was also statistically reduced at SEP (1.9+/-0.74) as well as frequency (8.7+/-1.76). No side effects were reported during the infusion as well as after the removal of the catheter.
  
  
  CONCLUSIONS
  The present study demonstrates that the prolonged intravesical instillation of a drug by in situ drug delivery system is a feasible procedure and seems to support the efficacy of RTX in the treatment of IC patients. However further studies are necessary and mandatory to confirm our results and to define the exact action mechanism of prolonged infusion of RTX, the dosage and the treatment schedule.
authors.affiliation: Department of Urology, University of Ferrara, via Savonarola no 4, Ferrara, Italy. Department of Urology, University of Ferrera, via Savonaroloa no 4, Ferrera, Italy. lazzeri.m@tiscali.it
authors.forename: M
authors.initials: M
authors.lastname: Lazzeri
authors.forename: M
authors.initials: M
authors.lastname: Spinelli
authors.forename: P
authors.initials: P
authors.lastname: Beneforti
authors.forename: S
authors.initials: S
authors.lastname: Malaguti
authors.forename: G
authors.initials: G
authors.lastname: Giardiello
authors.forename: D
authors.initials: D
authors.lastname: Turini
mesh_terms: D000283:Administration, Intravesical; D003556:Cystitis / Q000188:drug therapy*; D004224:Diterpenes / Q000008:administration & dosage*; D016503:Drug Delivery Systems; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D008875:Middle Aged; D009498:Neurotoxins / Q000008:administration & dosage*; D010865:Pilot Projects; D013997:Time Factors
chemical_list: D004224:Diterpenes; D009498:Neurotoxins; C024353:resiniferatoxin