Interstitial Cystitis, Painful Bladder Syndrome, oral treatment


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selected literature on intravesical treatment of PBS/IC

click on the title to jump to the abstract if available

meta-analyses

Intravesical treatments for painful bladder syndrome/interstitial cystitis.
Dawson T, Jamison J. Cochrane Database Syst Rev 2007 Oct 17;(4):CD006113
• Cochrane report on intravesical treatment for PBS/IC
• Evidence base for intravesical treatment is limited
• Quality of trial reports mixed
• BCG and oxybutynin reasonably well-tolerated; RTX showed no evidence of effect for most outcomes
• Little evidence for other treatments included in this review
• Randomised controlled trials and standardisation are still needed

double-blind randomized placebo-controlled studies

Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome.
Nickel JC, Moldwin R, Lee S, Davis EL, et al. BJU Int 2008 Nov 13. [Epub ahead of print].PMID: 19021619
- the purpose of this preliminary study was to assess the immediate and sustained relief of the symptoms of IC/PBS after a consecutive 5-day course of intravesical alkalinized lidocaine (PSD597) and to characterize the pharmacokinetics of single and multiple doses of intravesical PSD597 in a subgroup of patients
- the authors concluded that this treatment was effective for providing sustained improvement of IC/PBS symptoms beyond the acute treatment phase
- the drug was safe, well-tolerated and devoid of the systemic side-effects often experienced with oral drugs
- long-term studies are needed to determine the optimum regimen to maintain this favourable treatment effect.

Safety and Efficacy of the Use of Intravesical and Oral Pentosan Polysulfate Sodium for Interstitial Cystitis: A Randomized Double-Blind Clinical Trial.
Davis EL, El Khoudary SR, Talbott EO, et al. 2008;179:177-85
- randomized double-blind placebo-controlled study
- demonstrated safety and efficacy of combined intravesical and oral PPS for moderate and severe IC.

Intravesical resiniferatoxin for the treatment of interstitial cystitis: a randomized, double-blind, placebo controlled trial.
Payne CK, Mosbaugh PG, Forrest JB, et al. Urol 2005 May;173:1590-4
• single intravesical administration of RTX at doses of 0.01 microM to 0.10 microM was not effective in patients with interstitial cystitis

A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis.
Mayer R, Propert KJ, Peters KM, et al. J Urol 2005;173:1186-91
• the authors conclude that although the BCG safety profile was acceptable, the response rate for the primary outcome was low

A prospective, double-blind, randomized cross-over study evaluating changes in urinary pH for relieving the symptoms of interstitial cystitis.
Nguan C, Franciosi LG, Butterfield NN, et al. BJU Int 2005;95:91-4
• the authors conclude that there was no statistically significant difference in subjective pain scores on instilling urine at physiological pH or sodium-phosphate buffered saline in the patients with IC

The efficacy of intravesical Tice strain bacillus Calmette-Guerin in the treatment of interstitial cystitis: a double-blind, prospective, placebo controlled trial.
Peters K, Diokno A, Steinert B, et al. J Urol 1997;157:2090-4
• 30 subjects was enrolled in the study with a mean followup of 8 months (range 6 to 13)
• based on an exit questionnaire a responder was defined as one who rated the interstitial cystitis symptoms as moderately improved or better.
• a 60% BCG response rate was noted, compared to a 27% placebo response rate
• minimum voided volume and quality of life improved in the BCG group compared to placebo; adverse events were similar in each group, mostly irritative in nature, and no significant systemic events were noted.
• the authors conclude that intravesical Tice strain BCG appears to be safe and efficacious in the treatment of interstitial cystitis but that additional studies must be performed to confirm the results of this pilot study

A controlled study of dimethyl sulfoxide in interstitial cystitis.
Perez-Marrero R, Emerson LE, Feltis JT. J Urol 1988;140:36-9
• the authors conclude that DMSO proved to be superior to placebo in the objective and subjective improvement of patients with interstitial cystitis

open studies and non-placebo-controlled studies

Intravesical glycosaminoglycan replenishment with chondroitin sulphate in chronic forms of cystitis. A multi-national, multi-centre, prospective observational clinical trial. Nordling J, van Ophoven A. Arzneimittelforschung 2008;58:328-35 .(PMID:18751498)
- effectiveness, safety nd tolerability of instillation therapy with chondroitin sulphate was investigated in 286 patients with chronic forms of cystitis including radiation cystitis, overactive bladder, chronically recurring cystitis and IC.
- the instillation was effective and well tolerated in the treatment of chronic forms of cystitis associated with a possible GAG layer deficit, but the results need to be confirmed in a controlled study.

A real-life multicentre clinical practice study to evaluate the efficacy and safety of intravesical chondroitin sulphate for the treatment of interstitial cystitis.
Nickel JC, Egerdie B, Downey J, et al. BJU Int 2008 Sep 3. [Epub ahead of print]
• a multicentre, community based open-label study designed to assess the efficacy and safety of intravesical sodium chondroitin sulphate in the treatment of patients with the clinical diagnosis of interstitial cystitis (IC)
• patients with IC were treated with sodium chondroitin sulphate (Uracyst®) solution 2.0% via urinary catheter weekly for 6 weeks and then monthly for 16 weeks for a total of 10 treatments
• the primary endpoint was the percentage of responders to treatment as indicated by a marked or moderate improvement on a seven-point patient Global Response Assessment (GRA) scale at week 10 (4 weeks after the initial six treatments) compared with baseline; a secondary efficacy endpoint (durability) was the percentage of responders on the GRA scale after 10 treatments.
• 47% of the 53 enrolled patients with long standing moderately severe IC were responders at week 10; at 24 weeks, 60% were responders

Results of endovesical hyaluronic acid/chondroitin sulfate in the treatment of interstitial cystitis/painful bladder syndrome.
Porru D, Cervigni M, Nasta L, et al. Rev Recent Clin Trials 2008;3:126-9
• this study tested the effect of endovesical administration of combined hyaluronic acid and chondroitin sulfate in IC/PBS patients
• the authors concluded that this combination appears to be a safe and efficacious form of treating IC/PBS

Botulinum A Toxin Intravesical Injection in Patients With Painful Bladder Syndrome: 1-Year Followup.
Giannantoni A, Porena M, Costantini E, et al. J Urol 2008 Jan 17 [Epub ahead of print]
• in this small study, intravesically injected botulinum toxin A appeared to be effective for short-term treatment of PBS that has failed to respond to other treatment
• this form of treatment needs to be repeated after a few months

Dyspareunia response in patients with interstitial cystitis treated with intravesical lidocaine, bicarbonate, and heparin.
Blayne KW, Teichman JMH. Urology 2008;71:67-70
• the results of this study indicate that this intravesical therapeutic solution can provide relief for voiding symptoms, pain and dyspareunia in IC/PBS patients

Hyaluronan treatment of interstitial cystitis/painful bladder syndrome.
Riedl CR, Engelhardt PF, Daha KL, et al. Int Urogynecol J Pelvic Floor Dysfunct 2007 Dec 21 [Epub ahead of print]
• this study evaluated the efficacy of intravesical hyaluronan therapy in 126 patients with IC/PBS and mean disease duration of 6.1 years; to be eligible for hyaluronan treatment, a positive modified potassium test was requested as a sign of a urine-tissue barrier disorder
• patients were treated with weekly instillations of a 50 ml phosphate-buffered saline solution containing 40 mg sodium hyaluronate
• data were obtained by a visual analogue scale (VAS) questionnaire rating from 0 to 10 that asked for global bladder symptoms before and after therapy; additional questions evaluated the therapeutic impact on quality of life.
• 85% of the patients reported symptom improvement (2 or more VAS units); the mean initial VAS score of 8.5 decreased to 3.5 after therapy (p<0.0001); 55% remained with no or minimal bladder symptoms after therapy (VAS 0-2); 84% reported significant improvement of their quality of life
• intravesical therapy had to be initiated again with good success in 43 patients (34.5%) as symptoms recurred after discontinuation of treatment, while the rest stayed free of symptoms for up to 5 years
• in general, hyaluronan therapy was well tolerated and, with the exception of mild irritative symptoms, no adverse reactions were reported for a total of 1,521 instillations
• the authors conclude that timely hyaluronan instillation therapy may lead to complete symptom remission or even cure in part of the IC/PBS patients, while some responders need continuous intravesical therapy
• the present results suggest that selection of patients for hyaluronan therapy by potassium testing improves the outcome of intravesical therapy with a response rate of >80%

Did Patients With Interstitial Cystitis Who Failed to Respond to Initial Treatment With Bacillus Calmette-Guerin or Placebo in a Randomized Clinical Trial Benefit From a Second Course of Open Label Bacillus Calmette-Guerin?
Propert KJ, Mayer R, Nickel JC, Payne CK, Peters KM, Teal V, Burks D, Kusek JW, Nyberg LM, Foster HE; Interstitial Cystitis Clinical Trials Group. J Urol 2007;178(3 Pt 1):886-90
• the authors conclude that the low response rate for bacillus Calmette-Guerin in this open label case series further argues against the routine use of bacillus Calmette-Guerin as treatment for interstitial cystitis

Intravesical bacillus Calmette-Guerin and dimethyl sulfoxide for treatment of classic and nonulcer interstitial cystitis: a prospective, randomized double-blind study.
Peeker R, Haghsheno MA, Holmang S, Fall M. J Urol 2000;164:1912-5; discussion 1915-6
• the authors conclude that despite intravesical BCG has been presented as a promising new option for treatment of interstitial cystitis, they failed to demonstrate benefit from this treatment
• dimethyl sulfoxide (DMSO) had no positive effect on maximal functional capacity but resulted in a significant reduction in pain and urinary frequency, although only in patients with classic interstitial cystitis

case reports

[Intravesical instillation of resiniferatoxin for the patients with interstitial cystitis] [article in Japanese]
Takahashi S, Yanase M, Inoue R, et al. Hinyokika Kiyo 2006;52:911-3
• resiniferatoxin (RTX) treatment was given to 3 patients with incomplete improvement after hydrodistention; all 3 patients were free of bladder pain posttreatment and had slight improvement of the maximum voided volume
• the authors conclude that although RTX treatment required general anaesthesia against severe bladder pain it is effective for selected IC patients

reviews

Resiniferatoxin in the treatment of interstitial cystitis: a systematic review.
Mourtzoukou EG, Iavazzo C, Falagas ME. Int Urogynecol J Pelvic Floor Dysfunct 2008 Jun 19 [Epub ahead of print]
• in this review from Greece, the authors conclude that the effectiveness of resiniferatoxin in the treatment of interstitial cystitis remains unknown; six studies produced contradictory results

Pharmacologic management of painful bladder syndrome/interstitial cystitis: a systematic review.
Dimitrakov J, Kroenke K, Steer WD, et al. Arch Intern Med 2007;167:1922-9.
• over 180 different therapies have been tried for PBS/IC, yet evidence from trials remains inconclusive
• this study concludes that PPS may be modestly beneficial for PBS/IC
• there is insufficient evidence for other pharmacologic treatment
• a consensus on standardized outcome measures is urgently needed

Intravesical treatments for painful bladder syndrome/ interstitial cystitis.
Dawson T, Jamison J. Cochrane Database Syst Rev 2007 Oct 17;(4):CD006113

Hyaluronic Acid: An Effective Alternative Treatment of Interstitial Cystitis, Recurrent Urinary Tract Infections, and Hemorrhagic Cystitis?
Iavazzo C, Athanasiou S, Pitsouni E, Falagas ME. Eur Urol. 2007 Mar 20; [Epub ahead of print]
• a literature review on treatment of interstitial cystitis, hemorrhagic cystitis, and recurrent urinary tract infections with hyaluronic acid; the authors conclude that the available clinical data regarding the effectiveness of hyaluronic acid as a potential treatment of cystitis patients are limited and that there is a need for randomized controlled trials
see also: editorial comment

New frontiers in intravesical therapies and drug delivery.
Giannatoni A, Di Stasi SM, Chancellor MB, et al. Eur Urol 2006:50:1183-93
• Electromotive drug administration (EMDA), new in situ delivery systems and bioadhesive liposomes may make it possible to extend intravesical therapy and drug administration to many bladder diseases. Further research is needed to make this a reality (review)

Recent developments of intravesical therapy of painful bladder syndrome/interstitial cystitis: a review.
Toft BR, Nordling J. Curr Opin Urol 2006;16:268-72

Efficacy of interstitial cystitis treatments: a review.
Karsenty G, AlTaweel W, Hajebrahimi S, Corcos J. EAU-EBU Update Series 2006;4:47-61
• in this article, the degree of evidence regarding the clinical efficacy of available interstitial cystitis treatment options is reviewed
• only three therapies are supported by a high level of evidence: oral cimetidine and amitriptyline and the intravesical dimethylsulfoxide (DMSO)

not yet sorted

Critical appraisal of dimethyl sulfoxide treatment for interstitial cystitis: discomfort, side-effects and treatment outcome.
Rössberger J, Fall M, Peeker R. Scand J Urol Nephrol 2005;39:73-7 PMID: 15764276

Treatment of interstitial cystitis with Cystistat: a hyaluronic acid product.
Kallstrup EB, Jorgensen SS, Nordling J, Half T. Scand J Urol Nephrol 2005;39:143-7 PMID: 16032779

Enhanced binding of modified pentosan polysulfate and heparin to bladder: a strategy for improved treatment of interstitial cystitis.
Muthusamy A, Erickson DR, Sheykhnazari M, Bhavanandan VP. Urology 2006;67:209-13 PMID16413377

Effect of intravesical resiniferatoxin (RTX) on lower urinary tract symptoms, urodynamic parameters, and quality of life of patients with urodynamic increased bladder sensation.
Apostolidis A, Gonzales GE, Fowler CJ. Eur Urol 2006 May 4; [Epub ahead of print] PMID: 16697519

Successful downregulation of bladder sensory nerves with combination of heparin and alkalinized lidocaine in patients with interstitial cystitis.
Parsons CL. Urology 2005;65:45-8 PMID: 15667861

Absorption of alkalized intravesical lidocaine in normal and inflamed bladders: a simple method for improving bladder anesthesia.
Henry R, Patterson L, Avery N, et al. J Urol 2001;165(6 Pt 1):1900-3 PMID: 11371877