human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Objective . To evaluate changes in bladder capacity and potassium sensitivity after glycosaminoglycan ( GAG ) substitution therapy . Material and methods . The study population comprised two groups of female patients with bladder pain syndrome/interstitial cystitis ( BPS/IC ) : responders ( those with symptom improvement ) and non-responders ( those without symptom improvement ) after a 10-week period of intravesical , episodic , weekly , GAG substitution therapy . A total of 27 volunteers with increased pre-therapeutic potassium sensitivity were enrolled in the study and re-evaluated using the modified comparative potassium test ( maximal bladder capacity with a saline solution versus a 0.2 M KCl solution ) following intravesical GAG substitution therapy . Results . In the 13 responders , the average maximal bladder capacity increased by 17 % with the saline solution and by 101.5 % with the 0.2 M KCl solution . In the 14 non-responders , post-therapeutic average maximal bladder capacity was decreased by 35 % with the saline solution and remained relatively unchanged after instillation with a 0.2 M KCl solution . Conclusion . These data demonstrate that in patients who respond symptomatically to intravesical GAG substitution therapy , cystometric bladder capacity is increased , whereas non-responders experience a decrease in bladder capacity INTRODUCTION It has been reported in an open-label study that the combination of alkalinized lidocaine and heparin can immediately relieve the symptoms of urinary urgency , frequency , and pain associated with interstitial cystitis ( IC ) . This combination has also been reported to relieve pain associated with sex in patients with IC . AIM The aim of this study was to corroborate these findings in a multicenter setting . METHODS The study design was a multicenter prospect i ve , double-blind , crossover , placebo-controlled trial . Each participant met all of the clinical National Institute of Diabetes and Digestive and Kidney Diseases criteria ( excluding cystoscopy ) for IC . Each patient received drug and control , in r and om order , within 48 hours of enrolling in the study . MAIN OUTCOME MEASURES The primary outcome measure was percent change in pain score ( 11-point analog pain scale ) 12 hours after receiving the drug or control . Secondary measures were the global assessment response ( GAR ) of symptoms and 12-hour average urgency reduction determined from 11-point urgency scales . RESULTS Eighteen ( 18 ) patients completed the trial . The average reduction of pain over 12 hours was 21 % for control and 42 % for active drug ( P = 0.0363 ) . GAR was 13 % for control and 50 % for drug ( P = 0.0137 ) . Average urgency reduction was 13 % for control and 35 % for drug ( P = 0.0328 ) . CONCLUSIONS The combination of alkalinized lidocaine and heparin provides up to 12 hours of relief from urgency and pain associated with IC . This combination provides significant immediate relief of symptoms for patients with IC The aims of this study were to evaluate the efficacy and tolerability of intravesical instillations of high-molecular-weight hyaluronic acid ( HA ) 1.6 % and chondroitin sulfate ( CS ) 2.0 % in patients with refractory painful bladder syndrome/interstitial cystitis ( PBS/IC ) and to observe their impact on Quality of Life . Twenty-three women were enrolled . They received bladder instillations with HA and CS weekly for 20 weeks and then monthly for 3 months . Mean follow-up after completion of therapy was 5 months . We observed a significant improvement in urinary symptoms on voiding diaries and Visual Analogue Scale for frequency ( p = 0.045 ) , urgency ( p = 0.005 ) , and pain ( p = 0.001 ) . The O’Leary – Sant Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index result ed in a significant improvement in both scores ( p = 0.004 and 0.01 , respectively ) . The Pelvic Pain and Urgency/Frequency Symptom Scale only showed significant improvement in the symptom score ( p = 0.001 ) . This promising experience seems to offer an additional therapeutic option in patients with refractory PBS/IC OBJECTIVE It is not always possible to clearly differentiate the symptoms of overactive bladder and interstitial cystitis . A prospect i ve r and omized study was performed to determine whether instillation of sodium chondroitin sulphate for treatment of interstitial cystitis is also effective in treating overactive bladder . The expected benefit of this therapeutic approach in overactive bladder is based on the assumption that the glycosaminoglycan layer may be damaged in overactive bladder as well . MATERIAL AND METHODS Patients with chronic overactive bladder were r and omized to one of two study groups each including 41 patients . Group A was treated with an anticholinergic agent ( tolterodine ) , group B with sodium chondroitin sulphate ( Uropol S ) . The diagnosis was established on the basis of a gynecologic examination and history , urodynamic testing , introital ultrasound , and cystoscopy . Patients were treated for 12 months . RESULTS An improvement of symptoms was reported by 15/35 ( 43 % ) of the patients in group A ( p = 0.000 ) as compared with 23/32 ( 72 % ) of the patients in group B. The subjective outcome was corroborated by means of urodynamic testing , number of pads used , voiding frequency , and nycturia ( voiding diary ) . Quality of life increased significantly in both groups in the course of treatment but there was no significant difference between both groups . CONCLUSION The results of the study presented here suggest that restoring the glycosaminoglycan layer also improves or cures the symptoms in patients with overactive bladder . Patients clearly benefit from instillation of sodium chondroitin sulphate . These results must be confirmed in larger studies before a wider use of this therapeutic option can be recommended PURPOSE Based on the assumption that interstitial cystitis results from a defective mucous lining of the bladder epithelium , we investigated the activity of hyaluronic acid in the treatment of this disease . Hyaluronic acid is an important glycosaminoglycan present in all connective tissues , including the glycosaminoglycan layer of the vesical mucosa . It exhibits a variety of pharmacological properties that enhance its appeal for the therapy of interstitial cystitis . MATERIAL S AND METHODS A total of 25 patients with characteristic findings of interstitial cystitis refractory to other medical treatments participated in a trial of intravesical hyaluronic acid at a dose of 40 mg . weekly for 4 weeks and then monthly . Response to therapy was evaluated by symptom score , voiding diaries and visual analog scales . RESULTS An initial 56 % positive ( complete plus partial ) response rate at week 4 increased to 71 % by week 12 and response was maintained until week 20 . Beyond week 24 there was a moderate decrease in the effectiveness of the medication . There was no significant toxicity attributable to hyaluronic acid in the bladder . CONCLUSIONS The response of patients with refractory interstitial cystitis to the intravesical administration of hyaluronic acid was gratifying . In the past many therapies for interstitial cystitis which were initially considered promising failed the test of a controlled study . Such a study to determine the activity of hyaluronic acid in patients with interstitial cystitis is currently under way Introduction and hypothesisWe studied the feasibility and efficacy of intravesical instillations with 40 ml chondroitin sulfate 0.2 % solution to prevent or reduce acute radiation cystitis in women undergoing pelvic radiotherapy . Methods In a comparative pilot study in 20 patients , half of the patients received instillations . Instillations ' bother was measured with visual analog scores ( VAS , 0–10 ) ; bladder pain , with VAS ; micturition-related quality of life , with the urogenital distress inventory ( UDI ) . Results One of the instilled patients discontinued the instillations . The first median “ acceptability”-VAS was 0 ( range , 0–3 ) ; the last median was 1 ( range , 0–3 ) . “ Bladder pain”-VAS peaked halfway in the treatment among controls ( median , 1 ; range , 0–5 ) and after treatment in the instilled patients ( median , 1 ; range , 1–3 ) . UDI scores showed over time median follow-up scores at or above median baseline scores in controls and at or below median baseline scores in instilled patients . Conclusion Intravesical instillations with chondroitin sulfate 0.2 % solution may decrease the bother related to bladder symptoms and are well tolerated OBJECTIVES To compare the clinical effectiveness of different regimens of intravesical hyaluronic acid instillation for patients with interstitial cystitis/painful bladder syndrome . METHODS A total of 60 patients ( age 16 - 77 years ) diagnosed with interstitial cystitis/painful bladder syndrome were enrolled in this prospect i ve , r and omized study . A total of 30 patients were assigned to receive four weekly intravesical instillations of 40 mg of hyaluronic acid followed by five monthly instillations ( hyaluronic acid-9 group ) . Another 30 patients received 12 intravesical instillations of 40 mg hyaluronic acid every 2 weeks ( hyaluronic acid-12 group ) . Symptomatic changes after hyaluronic acid treatments were assessed using Interstitial Cystitis Symptom and Problem Indexes , pain visual analog scale , functional bladder capacity , frequency and nocturia in voiding diary , maximum flow rate , voided volume , postvoid residual volume , and Quality of Life Index at 1 , 3 and 6 months . RESULTS Of the 60 patients , 59 were evaluable at the end of the study . The Interstitial Cystitis Symptom Index , Interstitial Cystitis Problem Index and total score , pain visual analog scale , functional bladder capacity , maximum flow rate , and Quality of Life Index improved significantly after 6 months in both groups . The frequency and voided volume improved significantly only in the hyaluronic acid-12 group . However , patients with moderate and marked improvement were clinical ly similar in both groups . The measured variables did not differ between the two groups over the course of the study . CONCLUSION No significant difference was noted in the therapeutic effect between two hyaluronic acid instillation regimens for treatment of interstitial cystitis/painful bladder syndrome patients . Both groups showed significant improvement in symptom scores and Quality of Life Index To assess the immediate and sustained relief of the symptoms of interstitial cystitis/painful bladder syndrome ( IC/PBlS ) after a consecutive 5‐day course of treatment with intravesical alkalinized lidocaine ( PSD597 ) , and to characterize the pharmacokinetics of single and multiple doses of intravesical PSD597 in a subgroup of patients PURPOSE Increased urothelial permeability has been proposed as a cause of interstitial cystitis ( IC ) . The potassium sensitivity test assesses bladder discomfort after instillation of 0.4 M KCl for identification of increased urothelial permeability . Since exposure to 0.4 M KCl may be extremely painful for patients with IC we investigated a less traumatic alternative . MATERIAL S AND METHODS The study comprised 38 controls and 40 patients with IC . In all subjects cystometry was performed with 0.9 % NaCl followed by 0.2 M KCl , and filling volume at first urge and maximum bladder capacity ( Cmax ) were assessed for both solutions . RESULTS Controls did not show a significant change in Cmax . KCl decreased Cmax in 37 of 40 ( 92 % ) patients with IC with a mean decrease of 30 % . The examination was painless in all controls and in 33 of 40 ( 82 % ) patients with IC , and was moderately painful in 7 . CONCLUSIONS For demonstration of increased potassium sensitivity and diagnosis of IC , comparative assessment of Cmax is a well tolerated alternative to the 0.4 M potassium sensitivity test . Statistical evaluation of these results suggests that a decrease in Cmax greater than 30 % is indicative of IC OBJECTIVES To test the efficacy of a new intravesical therapeutic solution in relieving urgency/frequency and pain in interstitial cystitis ( IC ) . METHODS A solution of 40,000 U heparin , 8 mL 1 % lidocaine ( 80 mg ; group 1 ) or 2 % lidocaine ( 160 mg ; group 2 ) , and 3 mL 8.4 % sodium bicarbonate was administered intravesically in patients with newly diagnosed IC with significant frequency , urgency , and pain . Using the Patient Overall Rating of Improvement of Symptoms , the response to treatment was evaluated within 20 minutes of instillation in all patients , after 24 to 48 hours in group 2 , and after three treatments per week for 2 weeks in group 2 patients who elected to receive additional instillations . Significant symptom relief was defined as 50 % or greater symptom improvement . RESULTS After one instillation , 35 ( 75 % ) of 47 patients in group 1 ( 1 % lidocaine ) and 33 ( 94 % ) of 35 in group 2 ( 2 % lidocaine ) reported significant 
    Output:
    
agent
HMW-HA was significantly superior in cost effectiveness and cost efficacy to all other instillation regimes .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Objective . To evaluate changes in bladder capacity and potassium sensitivity after glycosaminoglycan ( GAG ) substitution therapy . Material and methods . The study population comprised two groups of female patients with bladder pain syndrome/interstitial cystitis ( BPS/IC ) : responders ( those with symptom improvement ) and non-responders ( those without symptom improvement ) after a 10-week period of intravesical , episodic , weekly , GAG substitution therapy . A total of 27 volunteers with increased pre-therapeutic potassium sensitivity were enrolled in the study and re-evaluated using the modified comparative potassium test ( maximal bladder capacity with a saline solution versus a 0.2 M KCl solution ) following intravesical GAG substitution therapy . Results . In the 13 responders , the average maximal bladder capacity increased by 17 % with the saline solution and by 101.5 % with the 0.2 M KCl solution . In the 14 non-responders , post-therapeutic average maximal bladder capacity was decreased by 35 % with the saline solution and remained relatively unchanged after instillation with a 0.2 M KCl solution . Conclusion . These data demonstrate that in patients who respond symptomatically to intravesical GAG substitution therapy , cystometric bladder capacity is increased , whereas non-responders experience a decrease in bladder capacity INTRODUCTION It has been reported in an open-label study that the combination of alkalinized lidocaine and heparin can immediately relieve the symptoms of urinary urgency , frequency , and pain associated with interstitial cystitis ( IC ) . This combination has also been reported to relieve pain associated with sex in patients with IC . AIM The aim of this study was to corroborate these findings in a multicenter setting . METHODS The study design was a multicenter prospect i ve , double-blind , crossover , placebo-controlled trial . Each participant met all of the clinical National Institute of Diabetes and Digestive and Kidney Diseases criteria ( excluding cystoscopy ) for IC . Each patient received drug and control , in r and om order , within 48 hours of enrolling in the study . MAIN OUTCOME MEASURES The primary outcome measure was percent change in pain score ( 11-point analog pain scale ) 12 hours after receiving the drug or control . Secondary measures were the global assessment response ( GAR ) of symptoms and 12-hour average urgency reduction determined from 11-point urgency scales . RESULTS Eighteen ( 18 ) patients completed the trial . The average reduction of pain over 12 hours was 21 % for control and 42 % for active drug ( P = 0.0363 ) . GAR was 13 % for control and 50 % for drug ( P = 0.0137 ) . Average urgency reduction was 13 % for control and 35 % for drug ( P = 0.0328 ) . CONCLUSIONS The combination of alkalinized lidocaine and heparin provides up to 12 hours of relief from urgency and pain associated with IC . This combination provides significant immediate relief of symptoms for patients with IC The aims of this study were to evaluate the efficacy and tolerability of intravesical instillations of high-molecular-weight hyaluronic acid ( HA ) 1.6 % and chondroitin sulfate ( CS ) 2.0 % in patients with refractory painful bladder syndrome/interstitial cystitis ( PBS/IC ) and to observe their impact on Quality of Life . Twenty-three women were enrolled . They received bladder instillations with HA and CS weekly for 20 weeks and then monthly for 3 months . Mean follow-up after completion of therapy was 5 months . We observed a significant improvement in urinary symptoms on voiding diaries and Visual Analogue Scale for frequency ( p = 0.045 ) , urgency ( p = 0.005 ) , and pain ( p = 0.001 ) . The O’Leary – Sant Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index result ed in a significant improvement in both scores ( p = 0.004 and 0.01 , respectively ) . The Pelvic Pain and Urgency/Frequency Symptom Scale only showed significant improvement in the symptom score ( p = 0.001 ) . This promising experience seems to offer an additional therapeutic option in patients with refractory PBS/IC OBJECTIVE It is not always possible to clearly differentiate the symptoms of overactive bladder and interstitial cystitis . A prospect i ve r and omized study was performed to determine whether instillation of sodium chondroitin sulphate for treatment of interstitial cystitis is also effective in treating overactive bladder . The expected benefit of this therapeutic approach in overactive bladder is based on the assumption that the glycosaminoglycan layer may be damaged in overactive bladder as well . MATERIAL AND METHODS Patients with chronic overactive bladder were r and omized to one of two study groups each including 41 patients . Group A was treated with an anticholinergic agent ( tolterodine ) , group B with sodium chondroitin sulphate ( Uropol S ) . The diagnosis was established on the basis of a gynecologic examination and history , urodynamic testing , introital ultrasound , and cystoscopy . Patients were treated for 12 months . RESULTS An improvement of symptoms was reported by 15/35 ( 43 % ) of the patients in group A ( p = 0.000 ) as compared with 23/32 ( 72 % ) of the patients in group B. The subjective outcome was corroborated by means of urodynamic testing , number of pads used , voiding frequency , and nycturia ( voiding diary ) . Quality of life increased significantly in both groups in the course of treatment but there was no significant difference between both groups . CONCLUSION The results of the study presented here suggest that restoring the glycosaminoglycan layer also improves or cures the symptoms in patients with overactive bladder . Patients clearly benefit from instillation of sodium chondroitin sulphate . These results must be confirmed in larger studies before a wider use of this therapeutic option can be recommended PURPOSE Based on the assumption that interstitial cystitis results from a defective mucous lining of the bladder epithelium , we investigated the activity of hyaluronic acid in the treatment of this disease . Hyaluronic acid is an important glycosaminoglycan present in all connective tissues , including the glycosaminoglycan layer of the vesical mucosa . It exhibits a variety of pharmacological properties that enhance its appeal for the therapy of interstitial cystitis . MATERIAL S AND METHODS A total of 25 patients with characteristic findings of interstitial cystitis refractory to other medical treatments participated in a trial of intravesical hyaluronic acid at a dose of 40 mg . weekly for 4 weeks and then monthly . Response to therapy was evaluated by symptom score , voiding diaries and visual analog scales . RESULTS An initial 56 % positive ( complete plus partial ) response rate at week 4 increased to 71 % by week 12 and response was maintained until week 20 . Beyond week 24 there was a moderate decrease in the effectiveness of the medication . There was no significant toxicity attributable to hyaluronic acid in the bladder . CONCLUSIONS The response of patients with refractory interstitial cystitis to the intravesical administration of hyaluronic acid was gratifying . In the past many therapies for interstitial cystitis which were initially considered promising failed the test of a controlled study . Such a study to determine the activity of hyaluronic acid in patients with interstitial cystitis is currently under way Introduction and hypothesisWe studied the feasibility and efficacy of intravesical instillations with 40 ml chondroitin sulfate 0.2 % solution to prevent or reduce acute radiation cystitis in women undergoing pelvic radiotherapy . Methods In a comparative pilot study in 20 patients , half of the patients received instillations . Instillations ' bother was measured with visual analog scores ( VAS , 0–10 ) ; bladder pain , with VAS ; micturition-related quality of life , with the urogenital distress inventory ( UDI ) . Results One of the instilled patients discontinued the instillations . The first median “ acceptability”-VAS was 0 ( range , 0–3 ) ; the last median was 1 ( range , 0–3 ) . “ Bladder pain”-VAS peaked halfway in the treatment among controls ( median , 1 ; range , 0–5 ) and after treatment in the instilled patients ( median , 1 ; range , 1–3 ) . UDI scores showed over time median follow-up scores at or above median baseline scores in controls and at or below median baseline scores in instilled patients . Conclusion Intravesical instillations with chondroitin sulfate 0.2 % solution may decrease the bother related to bladder symptoms and are well tolerated OBJECTIVES To compare the clinical effectiveness of different regimens of intravesical hyaluronic acid instillation for patients with interstitial cystitis/painful bladder syndrome . METHODS A total of 60 patients ( age 16 - 77 years ) diagnosed with interstitial cystitis/painful bladder syndrome were enrolled in this prospect i ve , r and omized study . A total of 30 patients were assigned to receive four weekly intravesical instillations of 40 mg of hyaluronic acid followed by five monthly instillations ( hyaluronic acid-9 group ) . Another 30 patients received 12 intravesical instillations of 40 mg hyaluronic acid every 2 weeks ( hyaluronic acid-12 group ) . Symptomatic changes after hyaluronic acid treatments were assessed using Interstitial Cystitis Symptom and Problem Indexes , pain visual analog scale , functional bladder capacity , frequency and nocturia in voiding diary , maximum flow rate , voided volume , postvoid residual volume , and Quality of Life Index at 1 , 3 and 6 months . RESULTS Of the 60 patients , 59 were evaluable at the end of the study . The Interstitial Cystitis Symptom Index , Interstitial Cystitis Problem Index and total score , pain visual analog scale , functional bladder capacity , maximum flow rate , and Quality of Life Index improved significantly after 6 months in both groups . The frequency and voided volume improved significantly only in the hyaluronic acid-12 group . However , patients with moderate and marked improvement were clinical ly similar in both groups . The measured variables did not differ between the two groups over the course of the study . CONCLUSION No significant difference was noted in the therapeutic effect between two hyaluronic acid instillation regimens for treatment of interstitial cystitis/painful bladder syndrome patients . Both groups showed significant improvement in symptom scores and Quality of Life Index To assess the immediate and sustained relief of the symptoms of interstitial cystitis/painful bladder syndrome ( IC/PBlS ) after a consecutive 5‐day course of treatment with intravesical alkalinized lidocaine ( PSD597 ) , and to characterize the pharmacokinetics of single and multiple doses of intravesical PSD597 in a subgroup of patients PURPOSE Increased urothelial permeability has been proposed as a cause of interstitial cystitis ( IC ) . The potassium sensitivity test assesses bladder discomfort after instillation of 0.4 M KCl for identification of increased urothelial permeability . Since exposure to 0.4 M KCl may be extremely painful for patients with IC we investigated a less traumatic alternative . MATERIAL S AND METHODS The study comprised 38 controls and 40 patients with IC . In all subjects cystometry was performed with 0.9 % NaCl followed by 0.2 M KCl , and filling volume at first urge and maximum bladder capacity ( Cmax ) were assessed for both solutions . RESULTS Controls did not show a significant change in Cmax . KCl decreased Cmax in 37 of 40 ( 92 % ) patients with IC with a mean decrease of 30 % . The examination was painless in all controls and in 33 of 40 ( 82 % ) patients with IC , and was moderately painful in 7 . CONCLUSIONS For demonstration of increased potassium sensitivity and diagnosis of IC , comparative assessment of Cmax is a well tolerated alternative to the 0.4 M potassium sensitivity test . Statistical evaluation of these results suggests that a decrease in Cmax greater than 30 % is indicative of IC OBJECTIVES To test the efficacy of a new intravesical therapeutic solution in relieving urgency/frequency and pain in interstitial cystitis ( IC ) . METHODS A solution of 40,000 U heparin , 8 mL 1 % lidocaine ( 80 mg ; group 1 ) or 2 % lidocaine ( 160 mg ; group 2 ) , and 3 mL 8.4 % sodium bicarbonate was administered intravesically in patients with newly diagnosed IC with significant frequency , urgency , and pain . Using the Patient Overall Rating of Improvement of Symptoms , the response to treatment was evaluated within 20 minutes of instillation in all patients , after 24 to 48 hours in group 2 , and after three treatments per week for 2 weeks in group 2 patients who elected to receive additional instillations . Significant symptom relief was defined as 50 % or greater symptom improvement . RESULTS After one instillation , 35 ( 75 % ) of 47 patients in group 1 ( 1 % lidocaine ) and 33 ( 94 % ) of 35 in group 2 ( 2 % lidocaine ) reported significant 
    Output:
    