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: PURPOSE In a previous retrospective analysis , cyclosporine A ( CyA ) was highly efficient in treating patients with interstitial cystitis . A prospect i ve r and omized study with this immunosuppressive agent was warranted . We compared CyA to pentosan polysulfate sodium ( PPS ) in patients with interstitial cystitis . MATERIAL S AND METHODS A total of 64 patients with interstitial cystitis meeting the National Institute of Diabetes and Digestive and Kidney Diseases criteria were enrolled in a r and omized prospect i ve study . Patients were r and omized in a 1:1 ratio to 1.5 mg/kg CyA twice daily ( 27 women , 5 men ) or 100 mg PPS 3 times daily ( 26 women , 6 men ) for a period of 6 months . The primary end point was daily micturition frequency , and secondary end points were mean and maximal voided volume , number of nocturia episodes , O'Leary-Sant symptom and problem indexes , visual analogue scale for pain , and subjective global response assessment . RESULTS CyA was superior to PPS in all clinical outcome parameters measured at 6 months . Micturition frequency in 24 hours was significantly reduced in the CyA arm compared to the PPS arm ( -6.7 + /- 4.7 vs -2.0 + /- 5.1 times ) . The clinical response rate ( according to global response assessment ) was 75 % for CyA compared to 19 % for PPS ( p < 0.001 ) . Although there were more adverse events in the CyA arm than in the PPS arm , 29 patients completed the 6-month followup in both groups . CONCLUSIONS CyA is more effective than PPS in interstitial cystitis Sodium pentosanpolysulfate ( Elmiron ) is a synthetic , sulfated polysaccharide available in an oral form that is excreted into the urine . This drug was used in a double-blind fashion to evaluate its efficacy in the management of symptoms of interstitial cystitis . A dose of 100 mg . 3 times daily was used for a minimum of 4 months and was continued for longer than 18 months in some individuals . A total of 62 patients was evaluated from 2 different medical centers . Subjective improvements were greater in all parameters when the drug was compared to placebo therapy , with significant improvement in pain , urgency , frequency and nocturia . Objective improvement in average voided volumes was greater with the drug than with placebo ( p equals 0.009 ) . No significant difference was found between drug and placebo groups in the average number of daily voiding episodes The O'Leary-Sant Interstitial Cystitis Symptom Index ( ICSI ) has been proposed as a treatment outcome measure in interstitial cystitis ( IC ) . The psychometric properties of the ICSI were assessed for reliability and validity in a r and omized , double-blind clinical study of 300 , 600 , and 900 mg daily dose of pentosan polysulfate sodium ( PPS ) in patients with IC . The ICSI contains 4 items that measure urgency and frequency of urination , nighttime urination , and pain or burning . The ICSI index score is the sum of the item scores ( range : 0 - 20 ) . ICSI scores were obtained at baseline , 4 , 8 , 12 , 16 , 24 , and 32 weeks of treatment . Patients ' overall ratings of improvement of symptoms ( PORIS ) scores evaluating improvements in pain , urgency , and overall IC symptoms were also collected except at baseline . A total of 376 patients were included in the analysis . Psychometric properties evaluated included variability ( range ) , test-retest reliability ( intraclass correlation coefficient [ ICC ] ) , internal consistency ( the Cronbach alpha ) , construct validity ( convergent , discriminant ) , responsiveness , and clinical ly meaningful change . The ICSI items and index score had good variability and test-retest reliability . The ICSI demonstrated internal consistency reliability and was responsive to change . Participants indicating a 75 % improvement in PORIS had a 48 % mean reduction in the ICSI score , while participants reporting 100 % improvement in PORIS had a 77 % mean reduction in the ICSI score . The ICSI is a valid , reliable , and responsive measure of change in IC symptoms . This outcome measure should be utilized in future treatment outcomes studies in IC PURPOSE This pilot study was design ed to evaluate the feasibility of a multicenter , r and omized , clinical trial in interstitial cystitis ( IC ) . Secondary objectives were to evaluate the safety and efficacy of oral pentosan polysulfate sodium ( PPS ) , hydroxyzine , and the combination to consider their use in a larger r and omized clinical trial . MATERIAL S AND METHODS A 2 x 2 factorial study design was used to evaluate PPS and hydroxyzine .  Participants 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 . The primary end point was a patient reported global response assessment . Secondary end points included vali date d symptom indexes and patient reports of pain , urgency and frequency . The target sample size was 136 participants recruited during 10 months . RESULTS A total of 121 ( 89 % of goal ) participants were r and omized over 18 months and 79 % provided complete followup data . The response rate for hydroxyzine was 31 % for those treated and 20 % for those not treated ( p = 0.26 ) . A nonsignificant trend was seen in the PPS treatment groups ( 34 % ) as compared to no PPS ( 18 % , p = 0.064 ) . There were no treatment differences for any of the secondary end points . Adverse events were mostly minor and similar to those in previous reports . CONCLUSIONS The low global response rates for PPS and hydroxyzine suggest that neither provided benefit for the majority of patients with IC . This trial demonstrated the feasibility of conducting a multicenter r and omized clinical trial in IC using uniform procedures and outcomes . However , slow recruitment underscored the difficulties of evaluating commonly available IC drugs PURPOSE We test the hypothesis that women without chronic pelvic pain or irritative voiding symptoms do not demonstrate petechial hemorrhages known as glomerulations that are characteristic of patients with interstitial cystitis . MATERIAL S AND METHODS A prospect i ve cohort design was used for examination with cystoscopy and bladder distention of 20 asymptomatic women undergoing tubal ligation . Cystoscopy with the patient under general anesthesia was performed to inspect the bladder mucosa before and after distention at 70 cm . of water pressure for 2 or 6 minutes . Photographs of the right , posterior and left of the bladder surfaces taken before and after the distention were scored on a scale of 1 to 5 using a panel of st and ards . Five urologists blinded to the source of individual photographs independently evaluated 120 research images interspersed with 46 other pictures from a library containing images from 19 symptomatic patients with and without interstitial cystitis . RESULTS A total of 20 normal women with a mean age plus or minus st and ard deviation of 29+/-6 years consented to participate in this trial during laparoscopic tubal ligation .  Photographs of bladder sites before and after distention with 890+/-140 ml . were scored as 1.4+/-0.3 ( before distention ) and 3.1+/-1.1 ( after distention ) on the scale of 1 to 5 . The increase in scores following distention in normal subjects was seen to the same degree and in the same proportion as in patients with symptoms of interstitial cystitis ( 8 of 19 symptomatic patients in this series met current diagnostic criteria for interstitial cystitis ) . Slight but significant differences were seen among sites in the bladder but not between 2 and 6-minute distention duration s. CONCLUSIONS Bladder mucosal lesions characteristically associated with irritative voiding symptoms and pelvic pain in patients diagnosed with interstitial cystitis were observed in asymptomatic women A r and omized , prospect i ve , double-blind , placebo-controlled study was conducted at 7 clinical centers on 148 patients . Patients received orally either 100 mg . pentosanpolysulfate ( a synthetic polysaccharide ) 3 times per day or a placebo . Of the patients on drug therapy 32 % showed significant improvement compared to 16 % of those on placebo ( p = 0.01 ) . This study provides a model to assess this disease quantitatively in a prospect i ve manner using a method whereby the patients globally assess their symptoms as either worse or improved by 0 , 25 , 50 , 75 or 100 % . Patients on drug therapy also experienced a significant decrease in pain and urgency ( p = 0.04 and 0.01 ) on analogue scales when compared to placebo and also more drug patients showed an average increase of more than 20 ml . in voided volume than did placebo patients ( p = 0.02 ) . All adverse effects were minor , with 7 in the drug group and 10 in the placebo group . The results support the concept that some patients with the interstitial cystitis syndrome may have abnormal bladder surface glycosaminoglycans PURPOSE We conducted a double-blind , sham controlled study to evaluate the safety , efficacy and feasibility of hyperbaric oxygenation for interstitial cystitis . MATERIAL S AND METHODS A total of 21 patients with interstitial cystitis were r and omized to 90 minutes treatment in a hyperbaric chamber pressurized with 100 % O2 to 2.4 atmosphere absolute for 30 treatments sessions or 1.3 atmosphere absolute , breathing normal air in the control group . Moderate or marked improvement in a global response assessment question naire was defined as treatment response ( primary outcomes ) . Secondary measurements included changes of pain and urgency evaluated by visual analog scales , functional bladder capacity and frequency . Changes in the O'Leary-Sant Interstitial Cystitis Index and rating of overall satisfaction with the therapeutic outcome were also reported . RESULTS There were 3 of 14 patients on verum and no control patients who were identified as responders ( p < 0.52 ) [ corrected ] At 12-month followup 3 patients ( 21.4 % ) still reported treatment response . Hyperbaric oxygenation result ed in a decrease of baseline urgency intensity from 60.2 + /- 15.0 to 49.9 + /- 35.2 mm at 3 months and decrease of pain intensity from 43.1 + /- 20.5 to 31.2 + /- 19.8 mm , respectively ( p < 0.05 ) . The Interstitial Cystitis Symptom Index score sum decreased from 25.7 to 19.9 points in patients on verum . Sham treatment did not result in improvement of the baseline parameters . CONCLUSIONS A total of 30 treatment sessions of hyperbaric oxygenation appear to be a safe , effective and feasible therapeutic approach to interstitial cystitis . In the treatment responders application of hyperbaric oxygenation result ed in a sustained decrease of interstitial cystitis symptoms with a discordant profile regarding the peak amelioration of the various interstitial cystitis symptoms compared with a normobaric , normoxic sham treatment OBJECTIVE To evaluate the therapeutic efficacy of intravesical pentosanpolysulphate ( PPS ) compared with placebo in patients with interstitial cystitis ( IC ) . PATIENTS AND METHODS Twenty patients who fulfilled the diagnostic criteria for IC participated in a double-blind placebo-controlled study ; 10 received intravesical PPS ( 300 mg in 50 mL of 0.9 % sodium chloride ) applied twice a week for 3 months and the other 10 received a placebo .  Symptomatic relief and objective variables ( bladder capacity voiding volumes and urinary frequency ) were assessed after 3 months and the long-term outcome of those continuing treatment was determined . RESULTS Of the patients treated with PPS , four gained significant symptomatic relief compared with only two receiving placebo . Only the urodynamic bladder capacity showed a statistically significant increase in patients treated with PPS ( P = 0.047 ) . At 18 months from the start of the study , the symptoms were relieved in eight patients while still receiving PPS instillations and in four without treatment . CONCLUSIONS These results suggest that intravesical PPS is an effective option for the treatment of IC and shows that the intravesical application of PPS is a safe treatment with no important side-effects Pentosan polysulfate sodium ( PPS ) was compared with placebo for the symptomatic therapy of interstitial cystitis in a double-blind , multicenter study . A total of 110 patients were enrolled and treated for three months . In this study , overall improvement of greater than 25 percent was reported by 28 percent of the PPS-treated patients and by 13 percent of the placebo-treated patients ( p = 0.03 ) . The investigators ' overall evaluation provided similar results , 26 percent vs 11 percent in favor of PPS ( p = 0.04 ) . Improvement in pain and pressure to urinate also favored PPS over placebo and approached statistical significance ( p = 0.07 and 0.08 ) . The incidence of adverse reactions was 6 percent in the PPS-treated group and 13 percent in the placebo-treated group . All adverse reactions were minor , and treatment was discontinued by 1 patient in the PPS group and 2 in the placebo group . In this study , PPS was found to be significantly more effective than , and equally as safe as , placebo PURPOSE Present therape 
    Output:
    
agent
Current evidence also suggests the efficacy of  dimethyl sulfoxide and amitryptyline therapy .
Hydroxyzine , intravesical bacille Calmette-Guérin  , and  resiniferatoxin therapy  failed to demonstrate efficacy , but evidence was inconclusive owing to method ological limitations .
Pentosan polysulfate may be modestly beneficial for symptoms of PBS/IC .
There is insufficient evidence for other pharmacologic treatments .
***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: PURPOSE In a previous retrospective analysis , cyclosporine A ( CyA ) was highly efficient in treating patients with interstitial cystitis . A prospect i ve r and omized study with this immunosuppressive agent was warranted . We compared CyA to pentosan polysulfate sodium ( PPS ) in patients with interstitial cystitis . MATERIAL S AND METHODS A total of 64 patients with interstitial cystitis meeting the National Institute of Diabetes and Digestive and Kidney Diseases criteria were enrolled in a r and omized prospect i ve study . Patients were r and omized in a 1:1 ratio to 1.5 mg/kg CyA twice daily ( 27 women , 5 men ) or 100 mg PPS 3 times daily ( 26 women , 6 men ) for a period of 6 months . The primary end point was daily micturition frequency , and secondary end points were mean and maximal voided volume , number of nocturia episodes , O'Leary-Sant symptom and problem indexes , visual analogue scale for pain , and subjective global response assessment . RESULTS CyA was superior to PPS in all clinical outcome parameters measured at 6 months . Micturition frequency in 24 hours was significantly reduced in the CyA arm compared to the PPS arm ( -6.7 + /- 4.7 vs -2.0 + /- 5.1 times ) . The clinical response rate ( according to global response assessment ) was 75 % for CyA compared to 19 % for PPS ( p < 0.001 ) . Although there were more adverse events in the CyA arm than in the PPS arm , 29 patients completed the 6-month followup in both groups . CONCLUSIONS CyA is more effective than PPS in interstitial cystitis Sodium pentosanpolysulfate ( Elmiron ) is a synthetic , sulfated polysaccharide available in an oral form that is excreted into the urine . This drug was used in a double-blind fashion to evaluate its efficacy in the management of symptoms of interstitial cystitis . A dose of 100 mg . 3 times daily was used for a minimum of 4 months and was continued for longer than 18 months in some individuals . A total of 62 patients was evaluated from 2 different medical centers . Subjective improvements were greater in all parameters when the drug was compared to placebo therapy , with significant improvement in pain , urgency , frequency and nocturia . Objective improvement in average voided volumes was greater with the drug than with placebo ( p equals 0.009 ) . No significant difference was found between drug and placebo groups in the average number of daily voiding episodes The O'Leary-Sant Interstitial Cystitis Symptom Index ( ICSI ) has been proposed as a treatment outcome measure in interstitial cystitis ( IC ) . The psychometric properties of the ICSI were assessed for reliability and validity in a r and omized , double-blind clinical study of 300 , 600 , and 900 mg daily dose of pentosan polysulfate sodium ( PPS ) in patients with IC . The ICSI contains 4 items that measure urgency and frequency of urination , nighttime urination , and pain or burning . The ICSI index score is the sum of the item scores ( range : 0 - 20 ) . ICSI scores were obtained at baseline , 4 , 8 , 12 , 16 , 24 , and 32 weeks of treatment . Patients ' overall ratings of improvement of symptoms ( PORIS ) scores evaluating improvements in pain , urgency , and overall IC symptoms were also collected except at baseline . A total of 376 patients were included in the analysis . Psychometric properties evaluated included variability ( range ) , test-retest reliability ( intraclass correlation coefficient [ ICC ] ) , internal consistency ( the Cronbach alpha ) , construct validity ( convergent , discriminant ) , responsiveness , and clinical ly meaningful change . The ICSI items and index score had good variability and test-retest reliability . The ICSI demonstrated internal consistency reliability and was responsive to change . Participants indicating a 75 % improvement in PORIS had a 48 % mean reduction in the ICSI score , while participants reporting 100 % improvement in PORIS had a 77 % mean reduction in the ICSI score . The ICSI is a valid , reliable , and responsive measure of change in IC symptoms . This outcome measure should be utilized in future treatment outcomes studies in IC PURPOSE This pilot study was design ed to evaluate the feasibility of a multicenter , r and omized , clinical trial in interstitial cystitis ( IC ) . Secondary objectives were to evaluate the safety and efficacy of oral pentosan polysulfate sodium ( PPS ) , hydroxyzine , and the combination to consider their use in a larger r and omized clinical trial . MATERIAL S AND METHODS A 2 x 2 factorial study design was used to evaluate PPS and hydroxyzine .  Participants 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 . The primary end point was a patient reported global response assessment . Secondary end points included vali date d symptom indexes and patient reports of pain , urgency and frequency . The target sample size was 136 participants recruited during 10 months . RESULTS A total of 121 ( 89 % of goal ) participants were r and omized over 18 months and 79 % provided complete followup data . The response rate for hydroxyzine was 31 % for those treated and 20 % for those not treated ( p = 0.26 ) . A nonsignificant trend was seen in the PPS treatment groups ( 34 % ) as compared to no PPS ( 18 % , p = 0.064 ) . There were no treatment differences for any of the secondary end points . Adverse events were mostly minor and similar to those in previous reports . CONCLUSIONS The low global response rates for PPS and hydroxyzine suggest that neither provided benefit for the majority of patients with IC . This trial demonstrated the feasibility of conducting a multicenter r and omized clinical trial in IC using uniform procedures and outcomes . However , slow recruitment underscored the difficulties of evaluating commonly available IC drugs PURPOSE We test the hypothesis that women without chronic pelvic pain or irritative voiding symptoms do not demonstrate petechial hemorrhages known as glomerulations that are characteristic of patients with interstitial cystitis . MATERIAL S AND METHODS A prospect i ve cohort design was used for examination with cystoscopy and bladder distention of 20 asymptomatic women undergoing tubal ligation . Cystoscopy with the patient under general anesthesia was performed to inspect the bladder mucosa before and after distention at 70 cm . of water pressure for 2 or 6 minutes . Photographs of the right , posterior and left of the bladder surfaces taken before and after the distention were scored on a scale of 1 to 5 using a panel of st and ards . Five urologists blinded to the source of individual photographs independently evaluated 120 research images interspersed with 46 other pictures from a library containing images from 19 symptomatic patients with and without interstitial cystitis . RESULTS A total of 20 normal women with a mean age plus or minus st and ard deviation of 29+/-6 years consented to participate in this trial during laparoscopic tubal ligation .  Photographs of bladder sites before and after distention with 890+/-140 ml . were scored as 1.4+/-0.3 ( before distention ) and 3.1+/-1.1 ( after distention ) on the scale of 1 to 5 . The increase in scores following distention in normal subjects was seen to the same degree and in the same proportion as in patients with symptoms of interstitial cystitis ( 8 of 19 symptomatic patients in this series met current diagnostic criteria for interstitial cystitis ) . Slight but significant differences were seen among sites in the bladder but not between 2 and 6-minute distention duration s. CONCLUSIONS Bladder mucosal lesions characteristically associated with irritative voiding symptoms and pelvic pain in patients diagnosed with interstitial cystitis were observed in asymptomatic women A r and omized , prospect i ve , double-blind , placebo-controlled study was conducted at 7 clinical centers on 148 patients . Patients received orally either 100 mg . pentosanpolysulfate ( a synthetic polysaccharide ) 3 times per day or a placebo . Of the patients on drug therapy 32 % showed significant improvement compared to 16 % of those on placebo ( p = 0.01 ) . This study provides a model to assess this disease quantitatively in a prospect i ve manner using a method whereby the patients globally assess their symptoms as either worse or improved by 0 , 25 , 50 , 75 or 100 % . Patients on drug therapy also experienced a significant decrease in pain and urgency ( p = 0.04 and 0.01 ) on analogue scales when compared to placebo and also more drug patients showed an average increase of more than 20 ml . in voided volume than did placebo patients ( p = 0.02 ) . All adverse effects were minor , with 7 in the drug group and 10 in the placebo group . The results support the concept that some patients with the interstitial cystitis syndrome may have abnormal bladder surface glycosaminoglycans PURPOSE We conducted a double-blind , sham controlled study to evaluate the safety , efficacy and feasibility of hyperbaric oxygenation for interstitial cystitis . MATERIAL S AND METHODS A total of 21 patients with interstitial cystitis were r and omized to 90 minutes treatment in a hyperbaric chamber pressurized with 100 % O2 to 2.4 atmosphere absolute for 30 treatments sessions or 1.3 atmosphere absolute , breathing normal air in the control group . Moderate or marked improvement in a global response assessment question naire was defined as treatment response ( primary outcomes ) . Secondary measurements included changes of pain and urgency evaluated by visual analog scales , functional bladder capacity and frequency . Changes in the O'Leary-Sant Interstitial Cystitis Index and rating of overall satisfaction with the therapeutic outcome were also reported . RESULTS There were 3 of 14 patients on verum and no control patients who were identified as responders ( p < 0.52 ) [ corrected ] At 12-month followup 3 patients ( 21.4 % ) still reported treatment response . Hyperbaric oxygenation result ed in a decrease of baseline urgency intensity from 60.2 + /- 15.0 to 49.9 + /- 35.2 mm at 3 months and decrease of pain intensity from 43.1 + /- 20.5 to 31.2 + /- 19.8 mm , respectively ( p < 0.05 ) . The Interstitial Cystitis Symptom Index score sum decreased from 25.7 to 19.9 points in patients on verum . Sham treatment did not result in improvement of the baseline parameters . CONCLUSIONS A total of 30 treatment sessions of hyperbaric oxygenation appear to be a safe , effective and feasible therapeutic approach to interstitial cystitis . In the treatment responders application of hyperbaric oxygenation result ed in a sustained decrease of interstitial cystitis symptoms with a discordant profile regarding the peak amelioration of the various interstitial cystitis symptoms compared with a normobaric , normoxic sham treatment OBJECTIVE To evaluate the therapeutic efficacy of intravesical pentosanpolysulphate ( PPS ) compared with placebo in patients with interstitial cystitis ( IC ) . PATIENTS AND METHODS Twenty patients who fulfilled the diagnostic criteria for IC participated in a double-blind placebo-controlled study ; 10 received intravesical PPS ( 300 mg in 50 mL of 0.9 % sodium chloride ) applied twice a week for 3 months and the other 10 received a placebo .  Symptomatic relief and objective variables ( bladder capacity voiding volumes and urinary frequency ) were assessed after 3 months and the long-term outcome of those continuing treatment was determined . RESULTS Of the patients treated with PPS , four gained significant symptomatic relief compared with only two receiving placebo . Only the urodynamic bladder capacity showed a statistically significant increase in patients treated with PPS ( P = 0.047 ) . At 18 months from the start of the study , the symptoms were relieved in eight patients while still receiving PPS instillations and in four without treatment . CONCLUSIONS These results suggest that intravesical PPS is an effective option for the treatment of IC and shows that the intravesical application of PPS is a safe treatment with no important side-effects Pentosan polysulfate sodium ( PPS ) was compared with placebo for the symptomatic therapy of interstitial cystitis in a double-blind , multicenter study . A total of 110 patients were enrolled and treated for three months . In this study , overall improvement of greater than 25 percent was reported by 28 percent of the PPS-treated patients and by 13 percent of the placebo-treated patients ( p = 0.03 ) . The investigators ' overall evaluation provided similar results , 26 percent vs 11 percent in favor of PPS ( p = 0.04 ) . Improvement in pain and pressure to urinate also favored PPS over placebo and approached statistical significance ( p = 0.07 and 0.08 ) . The incidence of adverse reactions was 6 percent in the PPS-treated group and 13 percent in the placebo-treated group . All adverse reactions were minor , and treatment was discontinued by 1 patient in the PPS group and 2 in the placebo group . In this study , PPS was found to be significantly more effective than , and equally as safe as , placebo PURPOSE Present therape 
    Output:
    