title: Contemporary management of the painful bladder: a systematic review.
abstract: BACKGROUND
  Different types of behavioural, dietary, interventional, pharmacologic, and surgical therapies have been used to treat painful bladder syndrome/interstitial cystitis (PBS/IC). Because of the paucity of randomised placebo-controlled studies on different treatments, an evidence-based management approach has not yet been developed.
  
  
  OBJECTIVE
  To critically review and synthesize data from a wide range of current therapeutic approaches to PBS/IC, to quantify the effect size from randomised controlled trials (RCTs), and to reach clinical agreement on the efficacy of treatments for PBS/IC.
  
  
  METHODS
  We performed a systematic review of the literature to identify articles published between 1990 and September 2010 on the management of PBS/IC. We included articles restricted to the English language published since 1990 to date that reported on oral and intravesical treatment, multimodal or combined treatment, and surgical treatment. For all RCTs, standardised mean differences (SMDs) were extracted and combined in a meta-analysis applying a random-effect model that incorporated the heterogeneity of effects. The four outcomes assessed in all studies were a change in the Interstitial Cystitis Symptom Index (ICSI), pain, urgency, and frequency. Non-RCTs (nRCTs) were analysed with a narrative synthesis of the evidence from all research designs.
  
  
  RESULTS
  We included 7709 adult patients from 29 RCTs and 57 nRCTs. Meta-analysis of RCTs showed that only cyclosporine A provided a simultaneous great effect size of SMD on ICSI, pain, and frequency. Amitriptyline at different dosages showed a great effect size of SMD on pain and urgency or on ICSI and frequency. The remaining RCTs showed sporadic significant changes in only one of the four considered parameters. The attributed levels of evidence for treatments reported in RCTs were 1b; grades of recommendations ranged from A to C. According to the Jadad score, 11 RCTs were high-quality studies. Meta-analysis of RCTs showed a great heterogeneity in the applied methodologies, clinical outcomes assessed, and the obtained results in different studies. The results from the nRCTs showed that the most frequently adopted treatment is oral pentosan polysulfate and that the use of botulinum A toxin intradetrusorial injections in PBS/IC is increasing. A high heterogeneity in drugs and treatment modalities, clinical outcomes, and obtained results was also found for nRCTs.
  
  
  CONCLUSIONS
  Limited evidence exists for the few treatments for PBS/IC. The lack of definitive conclusions is due to the great heterogeneity in methodology, symptoms assessment, duration of treatment, and follow-up in both RCTs and nRCTs.
authors.affiliation: Department of Urology and Andrology, University of Perugia, Perugia, Italy. agianton@libero.it
authors.forename: Antonella
authors.initials: A
authors.lastname: Giannantoni
authors.forename: Vittorio
authors.initials: V
authors.lastname: Bini
authors.forename: Roger
authors.initials: R
authors.lastname: Dmochowski
authors.forename: Philip
authors.initials: P
authors.lastname: Hanno
authors.forename: J Curtis
authors.initials: JC
authors.lastname: Nickel
authors.forename: Silvia
authors.initials: S
authors.lastname: Proietti
authors.forename: Jean Jacques
authors.initials: JJ
authors.lastname: Wyndaele
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018856:Cystitis, Interstitial / Q000175:diagnosis / Q000628:therapy*; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult