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 multicenter, randomized, double-blind, parallel group pilot evaluation of the efficacy and safety of intravesical sodium chondroitin sulfate versus vehicle control in patients with interstitial cystitis/painful bladder syndrome.
OBJECTIVE The goal of this pilot study was to gather information on differences between intravesical chondroitin sulfate and inactive vehicle control for treatment of interstitial cystitis/painful bladder syndrome ( IC/PBS ) . METHODS This was a prospect i ve , r and omized , double-blind , inactive vehicle-controlled , 12-week study ( 6-week treatment period , followed by a 6-week follow-up period ) in patients with IC/PBS . Patients were r and omized to weekly intravesical treatment with 2.0 % sodium chondroitin sulfate in phosphate-buffered saline or intravesical vehicle control . Primary efficacy analysis compared responders ( moderately or markedly improved ) according to the 7-point Global Response Assessment . Secondary endpoints include question naires focused on symptoms and quality of life . RESULTS Sixty-five evaluable patients were r and omized . At the primary endpoint analysis ( week 7 ) , 22.6 % of the vehicle control group were responders compared with 39.4 % of the active therapy group ( P = .15 ) . There was no statistically significant difference for any of the secondary endpoints . Overall , 76.9 % of the patients in the study reported at least 1 adverse event ; most were mild or moderate , the majority associated with the vehicle control treatment . Nine nonserious intervention-related adverse events were reported in 3 patients in the vehicle control group compared with 2 in 1 patient in the active treatment group . CONCLUSION The difference in treatment effect in this small underpowered study was not statistically significant , although twice as many patients reported a clinical ly significant benefit with intravesical chondroitin sulfate treatment compared with vehicle control treatment . This trial provides data required to design a well-powered r and omized vehicle-controlled trial to determine the true efficacy of this potentially promising therapy
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 .