Intravesical Resiniferatoxin for the Treatment of Interstitial Cystitis: A Randomized, Double-Blind, Placebo Controlled Trial

Payne, Christopher K.; Mosbaugh, Philip G.; Forrest, John B.; Evans, Robert J.; Whitmore, Kristene; Antoci, Joseph P.; Perez-Marrero, Ramon; Jacoby, Karny; Diokno, Ananias C.; O’Reilly, Keith J.; Griebling, Tomas L.; Vasavada, Sandip P.; Yu, Albert S.; Frumkin, Lyn R.

doi:10.1097/01.ju.0000154631.92150.ef

Cited by 176 publications

(110 citation statements)

References 16 publications

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“…Of the trials included, 4 reported BCG compared with placebo [32][33][34][35], 3 evaluated BoNTA in comparison with placebo [8,36,37], 2 reported RTX compared with placebo [38,39], 2 comparatively assessed chondroitin sulfate and placebo [7,40], 2 reported PPS compared with placebo [5,41], 1 evaluated lidocaine compared with placebo [42], 1 reported oxybutynin compared with placebo [43], and 1 assessed BCG in comparison with BoNTA [44]. The studies included assessed 905 patients in all.…”

Section: Resultsmentioning

confidence: 99%

“…Female patients accounted for at least 77 % of all subjects, who were all 18 years or older, excluding one study that did not mention patient age [35]. One study had a three-arm design, and included 0.05 μM RTX, 0.1 μM RTX, and placebo control groups [38]; another study had a four-arm design, and included 0.01 μM RTX, 0.05 μM RTX, 0.1 μM RTX, and placebo control groups [39]. Five studies identified additional treatments in both groups, including hydrodistention [8,37], oral PPS [5,41], and antibiotics [45].…”

Section: Resultsmentioning

confidence: 99%

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Intravesical treatment for interstitial cystitis/painful bladder syndrome: a network meta-analysis

et al. 2016

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Introduction and hypothesis Interstitial cystitis/painful bladder syndrome (IC/PBS) is a chronic inflammatory condition of the submucosal and muscular layers of the bladder. So far, there is no effective and targeted treatment strategy for IC/ PBS. This study aimed to assess the efficacy and safety of intravesical instillation treatment in IC/PBS patients. Methods We searched various databases up to October 2015. A network meta-analysis was performed to compare global response assessment (GRA) for different treatment strategies, including botulinum toxin A (BoNTA), bacillus CalmetteGuerin (BCG), resiniferatoxin (RTX), lidocaine, chondroitin sulfate (CS), oxybutynin, and pentosan polysulfate (PPS). A traditional meta-analysis was also performed. Results Sixteen trials evaluating 905 patients were included. Network meta-analysis indicated that BoNTA had the highest probability of being the best treatment course according to GRA assessment results (probability 81.7 %). BCG or BoNTA therapy yielded significant improvement in GRA incidence according to traditional meta-analysis. Patients who received PPS showed higher urinary frequency results compared with the placebo groups. BCG-and PPS-treated patients had elevated urinary urgency treatment effects compared with placebo groups. Bladder capacity restoration results also showed significant improvements in patients who received BoNTA compared with placebo-treated individuals. Conclusions These findings indicate that BoNTA therapy has the highest probability of being the best therapy according to GRA, and significantly improves bladder capacity in IC/PBS patients. BCG treatment also significantly increases the incidence of GRA and improves the symptoms of urinary urgency. PPS can significantly improve urinary frequency and urgency symptoms in IC/PBS patients.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Intravesical treatment for interstitial cystitis/painful bladder syndrome: a network meta-analysis

et al. 2016

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“…Of the 95 patients who completed the doubleblind placebo-controlled phase, 82 (86%; 41 from each group) elected to receive open-label treatment with PSD597 for 5 days (days [15][16][17][18][19]. Of these 82 patients, most (64, 78%), had improved GRA scores at day 22 (3 days after the end of open-label treatment) than before treatment; 11 (13%) were unchanged and four (5%), all of whom had initially received placebo during the double-blind phase, had worse scores.…”

Section: Resultsmentioning

confidence: 99%

“…Heparin is one of the most widely used intravesical therapies, but when used alone, has not been shown to produce immediate and sustained relief of symptoms [13]. Intravesical hyaluronic acid, chondroitin sulphate, the neurotoxins capsaicin and resiniferatoxin, and BCG have also been used as intravesical agents, but so far RCTs have shown them to be of little value [16][17][18][19][20].…”

Section: Discussionmentioning

confidence: 99%

Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome

et al. 2009

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OBJECTIVE 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. PATIENTS AND METHODS In all, 102 adult patients (99 women) with a clinical diagnosis of IC/PBlS were randomized from 19 centres in the USA and Canada to receive a daily intravesical instillation of 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), for 5 consecutive days. Patients were followed at intervals up to 29 days after the first instillation. 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. RESULTS Significantly more patients treated with PSD597 rated their overall bladder symptoms as moderately or markedly improved on the GRA scale 3 days after completing the 5‐day course of treatment (30% and 9.6%, respectively, for patients treated with PSD597 and placebo; P = 0.012). The treatment effects were also maintained beyond the end of treatment and are further supported by the secondary endpoints, including symptom and problem indices. The peak serum lidocaine concentration during the study was <2 µg/mL, and well below the toxic level (>5 µg/mL). CONCLUSION This preliminary study showed that PSD597 was effective for providing sustained amelioration of symptoms of IC/PBlS beyond the acute treatment phase. The drug was 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.

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“…In a randomized, double-blind, placebo-controlled trial published in 2005, no statistically significant benefit was seen with the use of this agent. 50 On the basis of currently available evidence, both BCG and resiniferatoxin should still be considered investigational interventions for the management of IC symptoms.…”

Section: Bacillus Calmette-guèrin and Resiniferatoxinmentioning

confidence: 99%

The management of interstitial cystitis: an update

Phatak

Foster

2006

Nat Rev Urol

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Intravesical Resiniferatoxin for the Treatment of Interstitial Cystitis: A Randomized, Double-Blind, Placebo Controlled Trial

Abstract: In the largest prospective, randomized 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.

Cited by 176 publications

References 16 publications

Intravesical treatment for interstitial cystitis/painful bladder syndrome: a network meta-analysis

Intravesical treatment for interstitial cystitis/painful bladder syndrome: a network meta-analysis

Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome

The management of interstitial cystitis: an update

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