Safety and dose flexibility clinical evaluation of intravesical liposome in patients with interstitial cystitis or painful bladder syndrome. Intravesical hyaluronic acid and alkalinized lidocaine for the treatment of severe painful bladder syndrome/interstitial cystitis The Clinical Effectiveness of Intravesical Sodium Hyaluronate (Cystistat®) in Patients with Interstitial Cystitis/Painful Bladder Syndrome and Recurrent Urinary Tract Infections Two-year efficacy and safety of botulinum a toxin intravesical injections in patients affected by refractory painful bladder syndrome. Botulinum A toxin intravesical injections for painful bladder syndrome: impact upon pain, psychological functioning and Quality of Life. A combined intravesical therapy with hyaluronic acid and chondroitin for refractory painful bladder syndrome/interstitial cystitis Results of endovesical hyaluronic acid/chondroitin sulfate in the treatment of Interstitial Cystitis/Painful Bladder Syndrome. 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. Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome Treatment of interstitial cystitis with Cystistat®, A hyaluronic acid product Intravesical liposome versus oral pentosan polysulfate for interstitial cystitis/painful bladder syndrome. Impact of intravesical hyaluronic acid and chondroitin sulfate on bladder pain syndrome/interstitial cystitis Intravesical hyaluronic acid for interstitial cystitis/painful bladder syndrome: a comparative randomized assessment of different regimens. Effect of intravesical glycosaminoglycan substitution therapy on bladder pain syndrome/interstitial cystitis, bladder capacity and potassium sensitivity Botulinum A toxin intravesical injection in patients with painful bladder syndrome: 1-year followup. Combined intravesical sodium hyaluronate/chondroitin sulfate therapy for interstitial cystitis/bladder pain syndrome: a prospective study Multimodal therapy for painful bladder syndrome / interstitial cystitis: pilot study combining behavioral, pharmacologic, and endoscopic therapies. Intravesical resiniferatoxin for the treatment of interstitial cystitis: a randomized, double-blind, placebo controlled trial. Intravesical instillation of hyaluronic acid prolonged the effect of bladder hydrodistention in patients with severe interstitial cystitis. Prophylactic vesical instillations with 0.2% chondroitin sulfate may reduce symptoms of acute radiation cystitis in patients undergoing radiotherapy for gynecological malignancies A rational combination of intravesical and systemic agents for the treatment of interstitial cystitis Phase I trial of intravesical gemcitabine in bacillus Calmette-Guérin-refractory transitional-cell carcinoma of the bladder. Standard versus Hydrophilic Catheterization in the Adjuvant Treatment of Patients with Superficial Bladder Cancer
To present single institution open-label experience with intravesical liposomes ( LPs ) , a mucosal protective agent , in patients with interstitial cystitis/painful bladder syndrome ( IC/PBS ) and to assess the safety and efficacy on IC/PBS symptoms . A total of 17 symptomatic IC/PBS patients were treated with intravesical LPs ( 80mg/40mL distilled water ) once a week for 4 weeks ( n=12 ) or twice a week treatment for 4 weeks ( n=5 ) . The primary outcome was the change in the O'Leary-Sant Symptom/Problem score and O'Leary-Sant total Score from baseline to Week 4 and Week 8 . Other outcome measurements included the changes in pain scale , urgency scale , voiding log , and patient global assessment . Both weekly and biweekly LP instillation regiments were well tolerated . The incidence of urinary incontinence , retention , or unanticipated adverse changes was not noted at any dose either during the treatment or at the 4-week follow-up . The O'Leary-Sant Symptom/Problem score , O'Leary-Sant total Score , and pain score were significantly improved from baseline at both dose regimens with added benefit with the biweekly regimen . Intravesical LPs treatment is safe and its efficacy has sustained duration . Furthermore large-scale , placebo-controlled studies are warranted to assess the efficacy for this promising new treatment for IC/PBS Introduction and hypothesisIntravesical instillation of hyaluronic acid ( HA ) may restore the integrity of glycosaminoglycan layer in patients with painful bladder syndrome/interstitial cystitis ( PBS/IC ) , and the benefit may be improved with addition of alkalinized lidocaine ( AL ) . Methods 48 women with severe PBS/IC who failed oral medications were enrolled and divided into one trial and two control groups . The trial group received intravesical 40 mg HA , 10 ml of 2 % lidocaine and 5 ml of 8.4 % sodium bicarbonate on a weekly basis for 8 weeks and then monthly for 4 months with a subsequent follow-up of 24 weeks , while the two control groups received 40 mg HA and mixture of 10 ml of 2 % lidocaine and 5 ml of 8.4%sodium bicarbonate respectively following the same procedure . Response to therapy was evaluated by Global Response Assessment , voids per day , Visual Analogue Scale for pain , frequency and urgency , O’leary-Sant Interstitial Cystitis Symptom Index and Problem Index , cystoscopy and bladder capacity . Results Overall 45 patients finished this study protocol . The HA + AL group and the AL group showed significant improvement at week 2 ( P < 0.01 ) , while the HA group began to show effect at week 4 ( P < 0.01 ) . There was no improvement in the AL group at week 24 and these patients quitted the study without follow up . Contrarily , the HA + AL and HA group kept on improving till the end of the study without significant difference between the two groups . Conclusions Intravesical instillation of HA and AL may provide both immediate and sustained relief of symptoms in severe PBS/IC in this preliminary study Objective : Painful bladder syndrome/interstitial cystitis ( PBS/IC ) and recurrent urinary tract infections ( UTI ) are clinical ly challenging conditions to manage in patients . We evaluate the clinical use of intravesical sodium hyaluronate ( Cystistat ® ) in both these patient groups who have completed treatment . Patients and Methods : Thirteen patients with recurrent UTIs ( Group I ) and 8 patients with PBS/IC ( Group II ) received intravesical sodium hyaluronate ( Cystistat ® ) . Preinstallation demographic parameters were statically comparable in both groups . The mean age of presentation was 54.6 years in Group I and 57.5 years in Group II ( p = 0.9 ) . All 13 patients in Group I were on low dose antibiotics . The mean number of installations completed in both groups was 9 ( range 4–21 ) . Results : Data was collected prospect ively using a st and ard pre- and post-treatment question er with the pelvic pain and urinary/frequency patient symptom scale . At a mean follow-up of 21 months a significant improvement in bladder pain ( p = 0.05 ) , daytime frequency ( p = 0.03 ) and quality of life ( p = 0.02 ) was noted in patients in Group I. Two patients had breakthrough UTIs during treatment . Within Group I , 7 ( 53 % ) patients responded well to treatment . Patients in Group II had a significant improvement in bladder pain ( p = 0.02 ) , urgency ( p = 0.01 ) , nocturia ( p = 0.01 ) and quality of life ( p = 0.04 ) . Within Group II , 6 patients ( 75 % ) responded to treatment . Conclusion : Intravesical sodium hyaluronate ( Cystistat ® ) can be used with minimal side effects and good compliance in both groups of patients with PBS and recurrent UTIs . Longer follow-up and larger patient numbers in both groups will be required to confirm the long-term efficacy of these two clinical ly challenging groups of patients INTRODUCTION AND AIM We report the 2-year efficacy and tolerability of intravesical botulinum A toxin ( BoNT/A ) injections in patients with painful bladder syndrome ( PBS ) associated with increased urinary frequency refractory to conventional treatments . MATERIAL S AND METHODS Thirteen women were prospect ively included in the study . The preliminary assessment included voiding diary , urodynamics , urinary tract ultrasound and the visual analog scale ( VAS ) for pain quantification . All patients received multiple injections of 200 U commercially available BoNT/A diluted in 20 ml 0.9 % NaCl , under cystoscopic guidance .  Clinical evaluation , urodynamics , urinary tract ultrasound and VAS were repeated at least two times per year throughout the follow-up . RESULTS A total of 58 injections were administered with a mean of 4.8 + /- 0.8 injections per patient . The mean interval between two consecutive injections was 5.25 + /- 0.75 months . At 1 and 4 mo follow up ten patients reported a subjective improvement . Mean VAS scores , mean daytime and night-time urinary frequency decreased significantly . Nine patients at 1 month and seven at the 4-month check-up complained of dysuria . The three non-responders to the first intravesical treatment session underwent another three months later with satisfactory results . At 1 and 2 years follow up the beneficial effects persisted in all patients . We did not observe any systemic side effects during the observation time . CONCLUSIONS Intravesically injected BoNT/A is effective and safe in the medium-term management of patients with PBS . As the beneficial effect decreased progressively within a few months after treatment , repeat injections of the neurotoxin were needed over time INTRODUCTION To assess the impact of intravesically injected botulinum A toxin ( BoNT/A ) upon bladder pain , urological complaints , symptoms of anxiety and depression , and Quality of Life ( QoL ) in patients with painful bladder symptoms ( PBS ) refractory to conventional treatment . PATIENTS AND METHODS In this prospect i ve study 14 patients received one injection of BoNT/A ( 200 U diluted in 20 ml 0.9 % NaCl ) , under cystoscopic guidance . At pre- and 3 months post- treatment all patients underwent an urological assessment ( voiding diary , urodynamics ) , a pain quantification on a visual analog scale ( VAS ) , an evaluation with the 14-item Hamilton Anxiety Rating Scale ( HAM-A ) to assess symptoms of psychic and somatic anxiety , an evaluation with the Hamilton Depression Rating Scale ( HAM-D ) to assess depression , and the 36-item Medical Outcomes Study Short Form ( SF-36 ) to assess QoL. Results . At pre-treatment all 14 patients had increased daytime and nighttime urinary frequency and high VAS scores . Nine patients had pathological HAM-A scores and all had pathological HAM-D scores . At the 3-month follow-up 10/14 patients reported a subjective improvement in pain . Mean VAS score , mean daytime and nighttime urinary frequency decreased significantly ( p < 0.01 , < 0.01 and < 0.01 , respectively ) . All domains in SF-36 and HAM-A significantly improved ( p<0.01 ) . All domains , except weight and sleep disorders , significantly improved in HAM-D , particularly somatoform symptoms ( p<0.01 ) , cognitive performance ( p<0.01 ) , and circadian variations ( p<0.01 ) . CONCLUSION In patients with refractory PBS with symptoms of anxiety , depression and poor QoL , BoNT/A intravesical treatment reduced bladder pain , improved psychological functioning , and well-being 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 OBJECTIVES The aim of our study was to test the effect of a more viscous compound than existent hyaluronic acid formulation in helping to restore a defective glycosaminoglycan layer , and therefore in improving Interstitial Cystitis/Painful Bladder Syndrome ( IC/PBS ) symptoms when administered intravesically in IC/PBS patients . METHODS A total of 23 female patients completed the study . Patients received endovesical administration of hyaluronic acid and chondroitin sulfate in normal saline , 40 ml , weekly for 12 weeks and then bi-weekly for 6 months , if there was initial response . RESULTS After 12 weeks treatment both Interstitial Cystitis Symptom and Problem Index ( ICSI/ICPI ) , pelvic pain and Urgency/Frequency Symptom Scale ( PUF ) showed a mean significant improvement , which was maintained thereafter . The average number of voidings and mean voiding volumes revealed significant improvement after the 12 weeks ' treatment period , with a significant reduction and increase , respectively . Mean voiding volume increased from 143 ml to 191 , which apparently was not reflected in a corresponding reduction of number of daily voids ( from 15,5 to 14 ) . VAS values decreased from 5,4 to 3,6 ( pain ) and from 6,0 to 3,5 ( urgency ) after the treatment cycle , showing a significant improvement . CONCLUSIONS In our preliminary experience , the administration of intravesical hyaluronic acid plus chondroitine sulphate appears to be a safe and efficacious method of treatment in IC/PBS 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 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 Objective . To determine whether intravesical hyaluronic acid is effective in reducing the urinary frequency and pain associated with interstitial cystitis/painful bladder syndrome ( IC/PBS ) . Material and methods . In a prospect i ve , unblinded , uncontrolled pilot study , 20 patients ( age range 34–80 years ) , all suffering from IC/PBS , received weekly bladder instillations of hyaluronic acid for 1 month and monthly instillations for a further 2 months . Patients were then offered further monthly instillations and all were subsequently evaluated after 3 years . Patient outcomes assessed were urinary frequency , use of analgesics and pain . Results . All patients completed the 3 months of hyaluronic acid treatment with mean decreases in nocturia and pain of 40 % and 30 % , respectively , and a decrease in analgesic use . Thirteen patients ( 65 % ) responded to treatment ( responders ) and continued therapy , while seven patients withdrew , six because of a lack of response and one due to cystectomy . In the 13 patients who continued hyaluronic acid instillations , four complete responders ( 30 % ) ceased therapy after a strong positive response ( 36 % , 60 % and 81 % decreases compared to baseline in day-time voids , night-time voids and pain scores , respectively ) which was maintained in the absence of continuous therapy , while after 3 years seven partial responders ( 35 % ) were still on therapy ( 25 % and 43 % decreases compared to baseline in day-time voids and pain scores , respectively ) . Two patients developed other diseases during follow-up and showed no response to long-term therapy . Hyaluronic acid was well tolerated by all patients . Conclusion . Hyaluronic acid safely reduced the pain and , to a lesser degree , the urinary frequency associated with IC PURPOSE We evaluated the safety and efficacy of intravesical liposomes , a mucosal protective agent , compared to oral pentosan polysulfate sodium for interstitial cystitis/painful bladder syndrome . MATERIAL S AND METHODS We performed a prospect i ve longitudinal study of the effect of 2 independent treatments ( intravesical liposomes and oral pentosan polysulfate sodium ) in patients with interstitial cystitis/painful bladder syndrome . Ten possible responses ( or measures ) to treatment were monitored at 3 time points , including baseline , and weeks 4 and 8 . A total of 24 patients with interstitial cystitis/painful bladder syndrome were evaluated in a 1:1 ratio to intravesical liposomes ( 80 mg/40 cc distilled water ) once weekly or to oral pentosan polysulfate sodium ( 100 mg ) 3 times daily for 4 weeks each . RESULTS No patient had urinary incontinence , retention or infection due to liposome instillation . There were no unanticipated adverse events and no significant worsening of symptoms during followup . Statistically significant decreases in urinary frequency and nocturia were observed in each treatment group . Statistically significant decreases in pain , urgency and the O'Leary-Sant symptom score were observed in the liposome group . Decreased urgency in the liposome group had the most profound effect of the ordinal measures . CONCLUSIONS Each glycosaminoglycan directed treatment seemed beneficial . Liposome intravesical instillation is safe for interstitial cystitis/painful bladder syndrome with potential improvement after 1 course of therapy for up to 8 weeks . Intravesical liposomes achieved efficacy similar to that of oral pentosan polysulfate sodium . Further large-scale placebo controlled studies are needed . Intravesical liposomes appear to be a promising new treatment for interstitial cystitis/painful bladder syndrome Introduction and hypothesisIntravesical instillations of hyaluronic acid ( HA ) and chondroitin sulfate ( CS ) may lead to regeneration of the damaged glycosaminoglycan layer in interstitial cystitis/bladder pain syndrome ( IC/BPS ) . Methods Twenty-two patients with IC/BPS received intravesical instillations ( 40 ml ) of sodium HA 1.6 % and CS 2.0 % in 0.9 % saline solution ( IALURIL ® , IBSA ) once weekly for 8 weeks , then once every 2 weeks for the next 6 months . Results The score for urgency was reduced from 6.5 to 3.6 ( p = 0.0001 ) , with a reduction in pain scores from an average of 5.6 to 3.2 ( p = 0.0001 ) . The average urine volume increased from 129.7 to 162 ml ( p < 0.0001 ) , with a reduction in the number of voids in 24 h , from 14 to 11.6 ( p < 0.0001 ) . The IC Symptom and Problem Index decreased from 25.7 to 20.3 ( p < 0.0001 ) , and the Pain Urgency Frequency score , from 18.7 to 12.8 ( p < 0.0001 ) . Conclusion The treatment appeared to be effective and well tolerated in IC/BPS in this initial experience 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 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 PURPOSE We evaluated the 1-year efficacy and tolerability of botulinum A toxin intravesically injected in patients with painful bladder symptoms associated with increased urinary frequency , refractory to conventional treatments . MATERIAL S AND METHODS Three men and 12 women were prospect ively included in the study . Under short general anesthesia the patients were given injections of 200 U commercially available botulinum A toxin diluted in 20 ml 0.9 % NaCl . Injections were performed submucosally in the bladder trigone and lateral walls under cystoscopic guidance . A voiding chart and the visual analog scale for pain were used , and urodynamics were performed before treatment , and 1 , 3 , 5 and 12 months later . RESULTS Overall 13 patients ( 86.6 % ) reported subjective improvement at the 1 and 3-month followups . The mean visual analog scale score , and daytime and nighttime urinary frequency were significantly decreased ( p < 0.05 , < 0.01 and < 0.05 , respectively ) . At the 5-month followup the beneficial effects persisted in 26.6 % of cases but increased daytime and nighttime urinary frequency , and an increased visual analog scale score were observed compared to baseline . At 12 months after treatment pain recurred in all patients . Nine patients complained of dysuria 1 month after treatment . Dysuria persisted in 4 cases at the 3-month followup and in 2 at the 5-month followup . CONCLUSIONS Intravesically injected botulinum toxin A is effective for short-term management of refractory painful bladder syndrome . The beneficial effects decreased progressively within a few months after treatment . Thus , repeat injections of the neurotoxin are required for efficacious treatment in patients with the disease Objectives : The aim of this study was to verify the efficacy and safety of intravesical treatment combining sodium hyaluronate ( HA ) and chondroitin sulfate ( CS ) in patients with interstitial cystitis/bladder pain syndrome ( IC/BPS ) . Methods : Between February 2010 and May 2011 , 20 consecutive women with IC/BPS were treated with intravesical instillations containing sodium HA ( 1.6 % ; 800 mg/50 ml ) and sodium CS ( 2 % ; 1 g/50 ml ) weekly for the first month , biweekly for the second month , and then monthly for at least 3 months . Before and after treatment , all patients filled in the Interstitial Cystitis Symptom Index and Problem Index ( ICSI/ICPI ) , the Patient Health Question naire 9 and the Pelvic Pain and Urgency/Frequency Patient Symptom Scale ( PUF ) . Treatment efficacy was assessed by comparing the pre- and post-treatment mean scores of the three question naires using Student ’s t test ( p value < 0.05 was considered significant ) . Results : Statistically significant mean decreases in ICSI ( from 13.0 to 9.3 ; p = 0.0003 ) , ICPI ( from 11.35 to 8.85 ; p = 0.0078 ) and PUF ( from 20.0 to 15.75 ; p = 0.0007 ) question naire scores were seen . No cases of side effects or complications were observed . The mean follow up was 5 months . Conclusions : Despite the limitations of this study , the outcomes confirmed the role of combination therapy with HA and CS as a safe and effective option for the treatment of IC/BPS . Further r and omized controlled studies with a higher number of patients and a longer follow-up period are needed to confirm these results PURPOSE We evaluated the effectiveness of combining behavioral therapy , pharmacologic therapy and endoscopic hydrodistension for treating  painful bladder syndrome / interstitial cystitis ( PBS/IC ) .  MATERIAL S AND METHODS Twenty-five patients with PBS/IC were prospect ively enrolled in a pilot multimodal behavioral , pharmacologic and endoscopic treatment protocol . Behavioral modification included diet recommendations , fluid restriction to 64 oz . /day , progressive timed voiding and Kegel exercises . Oral pharmacologic therapy consisted of daily doses of macrodantin 100 mg , hydroxyzine 10 - 20 mg and urised 4 tablets .  Patients underwent endoscopic bladder hydrodistention under anesthesia  at least 2 weeks after protocol enrollment . Behavioral and pharmacological treatments were continued after the hydrodistention . O'Leary-Sant question naire scores were recorded before starting the protocol , after pharmacologic/behavioral therapy , 2 months post-hydrodistension , and at scheduled follow-up . RESULTS Eighteen patients ( 72 % ) completed the pilot multimodal treatment protocol and were followed for a mean of 10.2 months . All patients were female with a median age of 36.3 years and had mean bladder capacity under anesthesia of 836 milliliters .  Mean O'Leary-Sant symptom index scores for baseline symptoms , after behavioral/pharmacologic treatment , post-hydrodistension and during follow up were 12.5 , 8.6 , 7.0 , and 6.7 ( p < 0.05 ) . Mean O'Leary-Sant problem index scores for baseline , after behavioral/pharmacologic treatment , post-hydrodistention and during follow up were 12.7 , 8.9 , 6.7 , and 7.7 ( p < 0.05 ) . CONCLUSION Our pilot multimodal protocol of behavioral modification , pharmacologic therapy and endoscopic hydrodistention demonstrated a significant progressive improvement in PBS/IC quality of life scores , compared to a pre-treatment baseline . These results should be vali date d in a larger , placebo controlled trial PURPOSE Interstitial cystitis is a painful bladder condition of unknown etiology and poorly understood pathophysiology . Current therapies have met with limited success . Vanilloid receptor agonists such as resiniferatoxin ( RTX ) desensitize C-fibers that transmit pain ; it is hypothesized that such drugs will be effective in the treatment of interstitial cystitis and painful bladder syndrome by decreasing the pain that leads to urinary frequency and urgency . MATERIAL S AND METHODS A r and omized , double-blind , placebo controlled study was conducted in 163 patients with interstitial cystitis . Participants were r and omly assigned to receive a single intravesical dose of 50 ml of either RTX 0.01 microM , 0.05 microM , 0.10 microM , or placebo .  Safety and efficacy was evaluated over 12 weeks . The primary efficacy endpoint was the Global Response Assessment , a 7-point scale rating overall change in symptoms of interstitial cystitis after 4 weeks . Secondary efficacy endpoints included reduction in pain , urgency , frequency , nocturia , average void volume , and the O'Leary-Sant Symptom and Problem Indexes . RESULTS RTX did not improve overall symptoms , pain , urgency , frequency , nocturia , or average void volume during 12 weeks followup . RTX result ed in a dose-dependent increase in the incidence of instillation pain , but was otherwise generally well tolerated . CONCLUSIONS In the largest prospect i ve , r and omized clinical trial reported to date with intravesical vanilloid therapy , single administration of RTX at doses of 0.01 microM to 0.10 microM was not effective in patients with interstitial cystitis OBJECTIVES To evaluate the efficacy of intravesical instillation of hyaluronic acid ( HA ) after hydrodistention for the treatment of patients with interstitial cystitis ( IC ) having small bladder capacity . METHODS A total of 47 patients with IC ( aged 27 - 76 years ) whose functional bladder capacity was less than 200 mL received bladder hydrodistention .  Thereafter , 20 patients received intravesical instillation of 40 mg HA weekly in the first month and then monthly in the following 2 months . Sixteen patients received intravesical heparin instead and 11 patients received hydrodistention alone as the control . Mean voids per day , visual analog scale for pain , and functional bladder capacity were measured before hydrodistention and 3 and 6 months after hydrodistention in all 3 groups and 9 months after hydrodistention in HA and heparin groups . RESULTS Two patients in the HA group and 1 in the heparin group failed to complete the treatment . Three months after hydrodistention , there was no improvement in the control group . Six and 9 months after hydrodistention , rate of improvement was significantly higher in the HA group than in the heparin group ( 77.8 % vs 33.3 % , P < .05 ; 50 % vs 20 % , P < .05 ) . At 9 months , heparin treatment did not show any improvement . Improvement in voids per day ( -1.8 + /- 2.5 , P < .01 ) , visual analog scale ( -0.9 + /- 1.1 , P < .01 ) , and bladder capacity ( 16 + /- 18 mL , P < .01 ) was still significant in the HA group . CONCLUSIONS Intravesical instillation of HA may obviously prolong the effect of bladder hydrodistention in patients with severe IC . Its effect was better than heparin 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 Objective . Interstitial cystitis is a condition with a poorly understood etiology and , consequently , various treatment options have been described in the literature , with a less than optimal outcome . The aim of this study was to examine the role of a combination of intravesical hydrocortisone and heparin , together with oral bladder sedatives and systemic triamcinolone , for the treatment of interstitial cystitis . Material and methods . A total of 26 patients who were diagnosed as having interstitial cystitis were treated with weekly intravesical hydrocortisone ( 200 mg ) and heparin ( 25 000 IU ) in physiological saline for 6 weeks . In addition , they were given oral bladder sedatives such as oxybutynin or tolterodine . Ulcerative , refractory and recurrent cases were treated with intramuscular triamcinolone ( 40 mg ) weekly for 6 weeks . Results . All patients experienced an improvement in symptoms within 48 h of their first intravesical instillation . While 19 patients ( 73 % ) experienced almost complete pain relief , five of the remaining seven patients improved with intramuscular triamcinolone .  Frequency reduced from a mean of 23.2 to 10.9 voids per day and was acceptable in 21 patients ( 80 % ) . Six patients ( 23 % ) had a relapse of symptoms in the form of pain and were treated satisfactorily by means of intramuscular triamcinolone . The mean duration of follow-up was 18.3 months . Conclusion . A combination of intravesical hydrocortisone and heparin , along with oral bladder sedatives and systemic steroids , has been used with encouraging results in a small group of patients with interstitial cystitis PURPOSE The aim of this phase I study was to determine the safety and toxicity profile of gemcitabine administered as an intravesical agent in patients with transitional-cell carcinoma ( TCC ) of the bladder . PATIENTS AND METHODS Patients with superficial bladder cancer refractory to intravesical bacillus Calmette-Guérin ( BCG ) therapy and refusing a cystectomy were considered eligible for the trial . Gemcitabine was given in the bladder for 1 hour twice weekly in 100 mL sodium chloride for a total of six treatments . After a 1-week break , a second course of six treatments over 3 weeks was given , followed by response assessment . Four dose levels were explored : 500 mg , 1,000 mg , 1,500 mg , and 2,000 mg . RESULTS Eighteen patients completed therapy : three at 500 mg , six at 1,000 mg , three at 1,500 mg , and six at 2,000 mg . No grade 3 or 4 toxicity was observed at 500 mg . At 1,000 mg , three patients developed hematuria and one had a skin reaction resembling grade 3 h and -foot syndrome . Three patients at 1,500 mg had no grade 3 or 4 toxicity . Of six patients at 2,000 mg , one had grade 3 thrombocytopenia and neutropenia without infection . Seven patients had a complete response ( negative cytology and posttreatment biopsy ) , and four patients had a mixed response ( negative bladder biopsy but positive cytology ) . CONCLUSION Gemcitabine has substantial activity as an intravesical agent in BCG-refractory TCC and warrants further investigation . Therapy given twice weekly was associated with minimal bladder irritation and tolerable myelosuppression . The recommended phase II dose for twice-weekly therapy is 2,000 mg Introduction : The aim of the present study is to compare a hydrophilic catheter to the st and ard polyvinyl chloride catheter with regard to bacteriological safety and overall comfort in patients undergoing intravesical immuno- or chemotherapy for bladder cancer . Material s and Methods : One hundred patients ( 80 males , 20 females ; median age 65.8 years , range 48–79 years ) eligible for intravesical prophylaxis of superficial bladder cancer recurrences were r and omized to receive intravesical therapy  using a st and ard catheter ( group A , n = 50 ) or a hydrophilic catheter ( group B , n = 50 ) . Urinalysis and urine culture were performed 2 days after catheterization . Comfort during catheterization was assessed by a 5-point visual analogue scale at the end of the first four instillations . Results : Urinary tract infection ( UTI ) was detected in 7.4 % of catheterizations in group A , whereas it occurred in 3.5 % of catheterizations in group B ( p < 0.01 ) . Escherichia coli was the most frequent pathogen regardless of the device used . At the end of each of the first four instillations , the mean score for discomfort was significantly higher in group A than in group B ( p < 0.001 ) , although catheterization was progressively better tolerated regardless of the device used ( both p < 0.005 ) . None of the patients were found to be suffering from orchitis , epididymitis or gross haematuria . Conclusion : Hydrophilic catheters may be used safely and are well tolerated by patients undergoing intravesical immuno- or chemotherapy . The hydrophilic catheter was associated with a significantly lower occurrence of UTI and higher acceptability compared to the st and ard device . These data should be considered with regard to patient compliance with intravesical therapy
Meta- analysis of BCG therapy showed improvement in symptoms according to the Wisconsin Interstitial Cystitis Symptom Inventory , but no difference in 24-h urinary frequency .
Conclusions Meta- analysis showed an improvement exclusively of the symptoms as measured by the Wisconsin Interstitial Cystitis Inventory , but not in 24-h urinary frequency , with BCG therapy .
Introduction and hypothesisThe objective of the study was to assess the effectiveness of intravesical treatment for painful bladder syndrome ( PBS ) .