CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 2 enrolled
Drug / intervention
DMSO +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03103594
NCT03103594Early Ph 1Completed

Comparison of the Treatment of Refractory Bladder Pain Syndrome With Dimethyl Sulfoxide (DMSO) Alone and DMSO as a Carrier Molecule for Botulinum Toxin A Instillation.

University of Pennsylvania·interventional·Posted Apr 6, 2017·Updated Jun 9, 2017

In Brief

A Early Phase 1 clinical trial evaluating DMSO and Botox for Bladder Pain Syndrome. Completed, enrolled 2 participants.

Detailed Summary

The purpose of this research study is to evaluate the efficacy of intravesical botulinum A toxin and DMSO in women with bladder pain syndrome who have not responded to first-line treatments. Bladder pain syndrome is suprapubic pain with bladder filling as well as frequency, urgency, and nocturia in the absence of urinary tract infection or other pathology. DMSO has been shown to reduce pain in women with bladder pain syndrome as well as increase bladder absorption of various drugs. Botulinum toxin A has also been shown to improve pain in women with bladder pain syndrome when injected into the bladder suburothelium via a cystoscope. The main objective of this study is to assess if DMSO can deliver botulinum toxin to the suburothelium of the bladder to produce the same effect as direct injection of Botulinum toxin and a better effect than DMSO alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Early Ph 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 6, 2017
Enrollment StartAug 1, 2015
Primary CompletionAug 1, 2016
Study CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 9.2 years ago

Interventions

DMSOdrug

DMSO will be instilled intravesically.

Botoxdrug

Botox will be instilled intravesically with DMSO.