title: Continuous intravesical lidocaine treatment for interstitial cystitis/bladder pain syndrome: safety and efficacy of a new drug delivery device.
abstract: Limited treatment options exist for patients who suffer from a painful bladder condition known as interstitial cystitis/bladder pain syndrome (IC/BPS). Whether given systemically (orally) or by short-duration (1 to 2 hours) exposure via intravesical instillation, therapeutic agents have exhibited poor efficacy because their concentrations in the bladder are low. A previous attempt to develop a drug delivery device for use in the bladder was unsuccessful, likely as a result of poor tolerability. A continuous lidocaine-releasing intravesical system (LiRIS) was designed to be retained in the bladder and release therapeutic amounts of the drug into urine over a period of 2 weeks. The device was tested in healthy volunteers and IC/BPS patients and was found to be well tolerated in both subject groups because of its small size and freedom of movement within the bladder. The 16 women with IC/BPS who were enrolled in the study met the National Institute of Diabetes and Digestive and Kidney Diseases criteria for bladder hemorrhages or Hunner's lesions. Subjects received either LiRIS 200 mg or LiRIS 650 mg for 2 weeks. Safety, efficacy, cystoscopic appearance of the bladder, and limited pharmacokinetic data were collected. Both doses were well tolerated, and clinically meaningful reductions were seen in pain, urgency, voiding frequency, and disease questionnaires. Cystoscopic examinations showed improvement on day 14 (day of removal) compared with day 1, including resolution of Hunner's lesions in five of six subjects with baseline lesions. Global response assessment showed an overall responder rate of 64% at day 14 and a sustained overall responder rate of 64% 2 weeks later. Extended follow-up suggests that the reduction in pain was maintained for several months after the device was removed.
authors: Department of Urology, Queen's University, Kingston, Ontario K7L 3N6, Canada.
authors: J Curtis
authors: JC
authors: Nickel
authors: Pankaj
authors: P
authors: Jain
authors: Neal
authors: N
authors: Shore
authors: Jessica
authors: J
authors: Anderson
authors: Dennis
authors: D
authors: Giesing
authors: Heejin
authors: H
authors: Lee
authors: Grace
authors: G
authors: Kim
authors: Karen
authors: K
authors: Daniel
authors: Suellen
authors: S
authors: White
authors: Cheryl
authors: C
authors: Larrivee-Elkins
authors: Julie
authors: J
authors: Lekstrom-Himes
authors: Michael
authors: M
authors: Cima
mesh_terms: D000283:Administration, Intravesical; D000328:Adult; D018856:Cystitis, Interstitial / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D008012:Lidocaine