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literature on intravesical treatment of BPS  
   

ESSIC uses the name bladder pain syndrome (BPS) instead of interstitial cystitis (IC) and/or painful bladder syndrome (PBS):
click here
for more details.

 

 
     
this section is divided into: meta-analyses  
  double-blind randomized placebo-controlled studies  
  open studies and non-placebo-controlled studies  
  case reports  
  reviews
     
meta-analyses  
   
  • Intravesical treatments for painful bladder syndrome/ interstitial cystitis.
    Dawson T, Jamison J. Cochrane Database Syst Rev 2007 Oct 17;(4):CD006113
    • the authors conclude that the evidence base for treating PBS/IC using intravesical preparations is limited
    • the quality of trial reports was mixed and in some cases this precluded any meaningful data extraction
    • BCG and oxybutin are reasonably well-tolerated and evidence is most promising for these
    • resiniferatoxin showed no evidence of effect for most outcomes and caused pain, which reduced treatment compliance
    • there is little evidence for the other treatments included in this review

 
   
double-blind randomized placebo-controlled studies  

BCG

 
  • Followup of Patients With Interstitial Cystitis Responsive to Treatment With Intravesical Bacillus Calmette-Guerin or Placebo.
    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 2008;179:552-5
    • the authors conclude that most patients who respond to therapy with intravesical BCG or placebo maintain improved symptoms for up to 68 weeks after the initiation of therapy
    • however, initial response rates are low and placebo responders demonstrated essentially the same durability of response as BCG responders
    • the results argue against the routine use of BCG in IC patients.

 
 
  • 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
 
DMSO  
 
lidocaine  
  • 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
    • study design: randomized placebo-controlled double blind trial - 5-day course of treatment with PSD597 (200 mg lidocaine, alkalinized with a sequential instillation of 8.4% sodium bicarbonate solution, to a final volume of 10 mL) or placebo (double-blind) - follow-up 29 days - efficacy was assessed by changes in the Global Response Assessment (GRA), Likert scales for bladder pain, urgency and frequency, and validated O’Leary-Sant IC symptom and problem indices.
    • the authors conclude that this preliminary study showed that intravesical alkalinized lidocaine (PSD597) was effective for providing sustained amelioration of symptoms of IC/PBlS beyond the acute treatment phase
    • the drug was found to be safe, well tolerated and devoid of the systemic side-effects often experienced with oral drug administration
    • long-term studies are needed to determine the optimum regimen to maintain this favourable treatment effect
 
pentosan  
  • 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. J Urol 2007 Nov 12; [Epub ahead of print]
    • 41 females diagnosed with IC were randomized to receive a combination of intravesical pentosan polysulfate sodium plus oral pentosan polysulfate sodium or intravesical placebo plus oral pentosan polysulfate sodium for 6 weeks; all subjects continued to receive oral pentosan polysulfate sodium for another 12 weeks
    • at week 18 the treatment group showed statistically significant improvement in all quality of life scores, while the placebo group showed significant improvement in only 3 quality of life scores compared to the baseline.
 
resiniferatoxin  
 
various  
 
   
open studies and non-placebo-controlled studies  
   
  • Intravesical liposome versus oral pentosan polysulfate for interstitial cystitis/painful bladder syndrome.
    Chuang YC, Lee WC, Lee WC, et al. J Urol 2009 Aug 13. [Epub ahead of print]
    PMID: 19683290
    - in this open study 12 BPS patients were treated with intravesical liposomes and compared with 12 patients treated with oral pentosan polysulfate (PPS)
    - intravesical liopsome therapy was found to be safe and the efficacy was similar to that of oral PPS
    - limitations of this study were the lack of placebo control randomization and the small number of patients; the authors indicate that the primary study objective was safety
  • 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
  • Dyspareunia response in patients with interstitial cystitis treated with intravesical lidocaine, bicarbonate, and heparin.
    Blayne KW, Teichman JMH. Urology 2008; doi:10.1016/j.urology.2007.09.067

    • in this open study 23 patients were treated with intravesical solution of lidocaine, heparin and sodium bicarbonate
    • the authors conclude that the intravesical solution provides relief of voiding symptoms, pain, and dyspareunia in IC/PBS patients and that a randomized, prospective trial is warranted
  • Hyaluronan treatment of interstitial cystitis/painful bladder syndrome.
    Riedl CR, Engelhardt PF, Daha KL, Morakis N, Pflüger H. 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%
  • Multiple intravesical instillations of low-dose resiniferatoxin in the treatment of refractory interstitial cystitis.
    Peng CH, Kuo HC. Urol Int 2007;78:78-81
    • this study suggests that once weekly instillations of RTX at the concentration of 10 nM during 4 weeks are effective in relieving lower urinary tract symptoms in patients with refractory IC
    • this study was not placebo-controlled and the number of patients enrolled was small (10 women and 3 men)

    • patients also received prophylactic antibiotics for 3 days after every instillation
    • all previous medications given for IC were discontinued 1 week prior to treatment with RTX
    • see also the double-blind randomized placebo-controlled study by Payne et al. above
 
 
  • Treatment of interstitial cystitis with Cystistat: a hyaluronic acid product.
    Kallestrup EB, Jorgensen SS, Nordling J, Hald T. Scand J Urol Nephrol 2005;39:143-7
    • in this prospective, unblinded, uncontrolled pilot study, 20 patients with 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
    • the authors conclude that hyaluronic acid safely reduced the pain and, to lesser degree, the urinary frequency associated with IC

 
 
 
  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  
     
   
   
 
  • Intravesical treatments for painful bladder syndrome/ interstitial cystitis.
    Dawson T, Jamison J. Cochrane Database Syst Rev 2007 Oct 17;(4):CD006113
    • the authors conclude that the evidence base for treating PBS/IC using intravesical preparations is limited
    • the quality of trial reports was mixed and in some cases this precluded any meaningful data extraction
    • BCG and oxybutin are reasonably well-tolerated and evidence is most promising for these
    • resiniferatoxin showed no evidence of effect for most outcomes and caused pain, which reduced treatment compliance
    • there is little evidence for the other treatments included in this review
 
   
   
 
  • 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)
 
     
     
     
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