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Philip M Hanno - One of the best experts on this subject based on the ideXlab platform.
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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
Urology, 2010Co-Authors: Curtis J Nickel, Blair R Egerdie, Gary Steinhoff, Bruce Palmer, Philip M HannoAbstract: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 prospective, randomized, 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 randomized 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 questionnaires focused on symptoms and quality of life. RESULTS Sixty-five evaluable patients were randomized. 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 clinically significant benefit with intravesical chondroitin sulfate treatment compared with Vehicle Control treatment. This trial provides data required to design a well-powered randomized Vehicle-Controlled trial to determine the true efficacy of this potentially promising therapy.
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ambulatory and office urology 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
2010Co-Authors: Curtis J Nickel, Blair R Egerdie, Gary Steinhoff, Bruce Palmer, Philip M HannoAbstract:Sixty-five evaluable patients were randomized. 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 clinically significant benefit with intravesical chondroitin sulfate treatment compared with Vehicle Control treatment. This trial provides data required to design a well-powered randomized Vehicle-Controlled trial to determine the true efficacy of this potentially promising therapy. UROLOGY 76: 804‐809, 2010. © 2010 Elsevier Inc.
Curtis J Nickel - One of the best experts on this subject based on the ideXlab platform.
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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
Urology, 2010Co-Authors: Curtis J Nickel, Blair R Egerdie, Gary Steinhoff, Bruce Palmer, Philip M HannoAbstract: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 prospective, randomized, 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 randomized 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 questionnaires focused on symptoms and quality of life. RESULTS Sixty-five evaluable patients were randomized. 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 clinically significant benefit with intravesical chondroitin sulfate treatment compared with Vehicle Control treatment. This trial provides data required to design a well-powered randomized Vehicle-Controlled trial to determine the true efficacy of this potentially promising therapy.
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ambulatory and office urology 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
2010Co-Authors: Curtis J Nickel, Blair R Egerdie, Gary Steinhoff, Bruce Palmer, Philip M HannoAbstract:Sixty-five evaluable patients were randomized. 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 clinically significant benefit with intravesical chondroitin sulfate treatment compared with Vehicle Control treatment. This trial provides data required to design a well-powered randomized Vehicle-Controlled trial to determine the true efficacy of this potentially promising therapy. UROLOGY 76: 804‐809, 2010. © 2010 Elsevier Inc.
Gary Steinhoff - One of the best experts on this subject based on the ideXlab platform.
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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
Urology, 2010Co-Authors: Curtis J Nickel, Blair R Egerdie, Gary Steinhoff, Bruce Palmer, Philip M HannoAbstract: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 prospective, randomized, 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 randomized 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 questionnaires focused on symptoms and quality of life. RESULTS Sixty-five evaluable patients were randomized. 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 clinically significant benefit with intravesical chondroitin sulfate treatment compared with Vehicle Control treatment. This trial provides data required to design a well-powered randomized Vehicle-Controlled trial to determine the true efficacy of this potentially promising therapy.
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ambulatory and office urology 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
2010Co-Authors: Curtis J Nickel, Blair R Egerdie, Gary Steinhoff, Bruce Palmer, Philip M HannoAbstract:Sixty-five evaluable patients were randomized. 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 clinically significant benefit with intravesical chondroitin sulfate treatment compared with Vehicle Control treatment. This trial provides data required to design a well-powered randomized Vehicle-Controlled trial to determine the true efficacy of this potentially promising therapy. UROLOGY 76: 804‐809, 2010. © 2010 Elsevier Inc.
Blair R Egerdie - One of the best experts on this subject based on the ideXlab platform.
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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
Urology, 2010Co-Authors: Curtis J Nickel, Blair R Egerdie, Gary Steinhoff, Bruce Palmer, Philip M HannoAbstract: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 prospective, randomized, 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 randomized 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 questionnaires focused on symptoms and quality of life. RESULTS Sixty-five evaluable patients were randomized. 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 clinically significant benefit with intravesical chondroitin sulfate treatment compared with Vehicle Control treatment. This trial provides data required to design a well-powered randomized Vehicle-Controlled trial to determine the true efficacy of this potentially promising therapy.
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ambulatory and office urology 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
2010Co-Authors: Curtis J Nickel, Blair R Egerdie, Gary Steinhoff, Bruce Palmer, Philip M HannoAbstract:Sixty-five evaluable patients were randomized. 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 clinically significant benefit with intravesical chondroitin sulfate treatment compared with Vehicle Control treatment. This trial provides data required to design a well-powered randomized Vehicle-Controlled trial to determine the true efficacy of this potentially promising therapy. UROLOGY 76: 804‐809, 2010. © 2010 Elsevier Inc.
Bruce Palmer - One of the best experts on this subject based on the ideXlab platform.
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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
Urology, 2010Co-Authors: Curtis J Nickel, Blair R Egerdie, Gary Steinhoff, Bruce Palmer, Philip M HannoAbstract: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 prospective, randomized, 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 randomized 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 questionnaires focused on symptoms and quality of life. RESULTS Sixty-five evaluable patients were randomized. 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 clinically significant benefit with intravesical chondroitin sulfate treatment compared with Vehicle Control treatment. This trial provides data required to design a well-powered randomized Vehicle-Controlled trial to determine the true efficacy of this potentially promising therapy.
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ambulatory and office urology 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
2010Co-Authors: Curtis J Nickel, Blair R Egerdie, Gary Steinhoff, Bruce Palmer, Philip M HannoAbstract:Sixty-five evaluable patients were randomized. 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 clinically significant benefit with intravesical chondroitin sulfate treatment compared with Vehicle Control treatment. This trial provides data required to design a well-powered randomized Vehicle-Controlled trial to determine the true efficacy of this potentially promising therapy. UROLOGY 76: 804‐809, 2010. © 2010 Elsevier Inc.
