Trial reportInternational urogynecology journal and pelvic floor dysfunction
Prospective, randomized, double-blind study of safety and tolerability of intravesical resiniferatoxin (RTX) in interstitial cystitis (IC).
Trial report in International urogynecology journal and pelvic floor dysfunction. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 8 syntheses or guidelines pooled it, 70 citations in OpenAlex.
- Comparative effectiveness and safety of intravesical instillation treatment of interstitial cystitis/bladder pain syndrome: a systematic review and network meta-analysis of randomized controlled trials.International urogynecology journal · 2021Pooled it
- Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis.The Cochrane database of systematic reviews · 2020Pooled it
- Pooled it
- Intravesical treatment of painful bladder syndrome: a systematic review and meta-analysis.International urogynecology journal · 2012Pooled it
- AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome.The Journal of urology · 2011Guideline
- Resiniferatoxin in the treatment of interstitial cystitis: a systematic review.International urogynecology journal and pelvic floor dysfunction · 2008Pooled it
- Intravesical treatments for painful bladder syndrome/ interstitial cystitis.The Cochrane database of systematic reviews · 2007Pooled it
- Pharmacologic management of painful bladder syndrome/interstitial cystitis: a systematic review.Archives of internal medicine · 2007Pooled it
- Review
- Acute Intravesical Capsaicin for the Study of TRPV1 in the Lower Urinary Tract: Clinical Relevance and Potential for Innovation.Medical sciences (Basel, Switzerland) · 2022Review
- Safety and efficacy of intravesical instillation of resiniferatoxin in healthy cats: A preliminary study.Frontiers in veterinary science · 2022Article
- Regulation of transient receptor potential cation channel subfamily V1 protein synthesis by the phosphoinositide 3-kinase/Akt pathway in colonic hypersensitivity.Experimental neurology · 2017Article
- Intravesical treatment for interstitial cystitis/painful bladder syndrome: a network meta-analysis.International urogynecology journal · 2017Review
- Review of intravesical therapies for bladder pain syndrome/interstitial cystitis.Translational andrology and urology · 2015Review
- Current recommendations for bladder instillation therapy in the treatment of interstitial cystitis/bladder pain syndrome.Current urology reports · 2013Review
- Differential effects of intravesical resiniferatoxin on excitability of bladder spinal neurons upon colon-bladder cross-sensitization.Brain research · 2013Article
- Lack of transient receptor potential vanilloid 1 channel modulates the development of neurogenic bladder dysfunction induced by cross-sensitization in afferent pathways.Journal of neuroinflammation · 2013Article
- Effects of combination treatment of intravesical resiniferatoxin instillation and hydrodistention in patients with refractory painful bladder syndrome/interstitial cystitis: a pilot study.International neurourology journal · 2012Article
- Up-regulation of brain-derived neurotrophic factor in primary afferent pathway regulates colon-to-bladder cross-sensitization in rat.Journal of neuroinflammation · 2012Article
- Acute colonic inflammation triggers detrusor instability via activation of TRPV1 receptors in a rat model of pelvic organ cross-sensitization.American journal of physiology. Regulatory, integrative and comparative physiology · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine the safety and tolerability of intravesical resiniferatoxin (RTX) in interstitial cystitis (IC) patients. MATERIALS AND
methodsIC patients were instilled with 50 cc of test solution containing either placebo, 0.05 microM or 0.10 microM RTX in the bladder. Plasma concentration of RTX and its degradant resiniferonol 9-, 13-, 14-orthophenylacetate was measured. Immediate post-treatment blood sampling and cystoscopy were performed. Symptoms were evaluated before treatment, at 4- and at 12-week follow-ups, using VAS indicator for pain, voiding diary, and O'Leary's IC symptom/problem indices.
resultsAmong 22 patients observed (ten in 0.10 microM RTX, eight in 0.05 microM RTX, and four in placebo groups), the most commonly reported adverse event was pain during instillation (80.0%, 87.5%, and 25.0%). No serious adverse events were reported.
conclusionsUse of intravesical RTX in IC patients is associated with important tolerability issues but safe at 0.10 microM and 0.05 microM.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.