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 results from the n RCTs 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 .
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 n RCTs
CONTEXT 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 r and omised 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 r and omised controlled trials ( RCTs ) , and to reach clinical agreement on the efficacy of treatments for PBS/IC .
A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis.
PURPOSE We compared intravesical bacillus Calmette-Guerin ( BCG ) to placebo instillations in patients with treatment refractory interstitial cystitis ( IC ) . MATERIAL S AND METHODS Subjects who met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC , and reported at least moderate pain and frequency for a minimum of 6 months before study entry , were r and omized to 6 weekly double-blinded intravesical instillations of either BCG or placebo , and then followed for a total of 34 weeks . The primary outcome was a patient reported global response assessment at week 34 , supplemented with medications for IC during weeks 31 to 34 . Secondary outcomes included a 24-hour voiding diary , pain , urgency , vali date d IC symptom indexes and adverse events . The target sample size was 260 participants , design ed to detect a difference in response rates between placebo and BCG of 30 % and 50 % , respectively . RESULTS A total of 265 participants were r and omized and 17 ( 6 % ) patients withdrew from study . The response rates for the primary outcome were 12 % for placebo and 21 % for BCG ( p = 0.062 ) . Small improvements were observed for all secondary outcomes , some more so with BCG , but these differences were of borderline statistical significance . Although a large number of adverse events were reported in the BCG arm , there was no statistically significant difference between the treatment arms in overall adverse event rates . CONCLUSIONS Although the BCG safety profile was acceptable , the response rate for the primary outcome was low . Effective medical treatment for patients with moderate to severe interstitial cystitis remains elusive
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 results from the n RCTs 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 .
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 n RCTs
CONTEXT 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 r and omised 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 r and omised controlled trials ( RCTs ) , and to reach clinical agreement on the efficacy of treatments for PBS/IC .