Comparison of the Treatment of Refractory Bladder Pain Syndrome With DMSO and DMSO With Botulinum Toxin A

What Was Tested

In this early phase 1 trial, researchers set out to test DMSO (dimethyl sulfoxide, non-peptide solvent).

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.

It had two arms (groups): DMSO alone (active comparator) and DMSO with Botox (experimental).

Half of the patients will undergo DMSO instillation.

The registry classes the interventions as drug.

More on the Plan

If the patient also has atypical cystoscopic and histological features then they are categorized as having Interstitial Cystitis.

Dimethyl sulfoxide (DMSO) is an FDA-approved treatment for BPS and is thought to work by its exceptional solvent properties.

Using fluorescence they were able to show that with DMSO the chemotherapy drug was able to extend into the deeper layers of the bladder wall compared to just the epithelial layer in those that received just the chemotherapy drug.

The investigators hypothesize that DMSO can deliver botulinum toxin to the suburothelium of the bladder to produce the same or similar effect as direct injection.

Who Took Part

The registry lists 2 actual participants took part.

It was open to women only aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women ages 18-75 years, capable of giving consent. Previously diagnosed with bladder pain syndrome/Interstitial cystitis that is refractory to dietary and behavioral modifications with an O'Leary-Sant score of 12 at baseline. Patients should have no change in their oral medications for bladder pain syndrome in the last 3 months. Patients with respiratory conditions will be required to present a medical clearance before administration Botulinum toxin.

The full record lists 4 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got DMSO (dimethyl sulfoxide, non-peptide solvent) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind DMSO (dimethyl sulfoxide, non-peptide solvent) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2015-08 with completion listed for 2016-08.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Pain Score (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of DMSO (dimethyl sulfoxide, non-peptide solvent) in 2 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the DMSO (dimethyl sulfoxide, non-peptide solvent) compound page, all human trials.