Comparative Study Between Hyperbaric Therapy and Intravesical Dimethyl Sulfoxide Instillation for Interstitial Cystitis

Plain-language guide to NCT01069263: not phased randomized trial of DMSO (dimethyl sulfoxide, non-peptide solvent), 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01069263
Phase: not phased
Status: status unknown
Start: 2010-02
Completion (planned or actual): 2015-03
Participants: 60 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Interstitial Cystitis
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around DMSO (dimethyl sulfoxide, non-peptide solvent).

It had two arms (groups): Intravesical DMSO instillation (active comparator) and Hyperbaric Oxygen Therapy (HBOT) (experimental).

The registry classes the interventions as drug and other.

More on the Plan

The etiology is yet not obvious.

The current acceptable theory is injury or dysfunction of the Mucus (Glycosaminoglycans) layer that covers the inner surface of the urinary bladder.

Abnormal diffusion of toxins from the urine to the walls of the bladder leads to inflammation, pain and scarring.

Many types of treatments were described but most of them were not evaluated in well designed randomized controlled studies.

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: NIDDK diagnosis of interstitial cystitis.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: previous treatment of hyperbaric therapy; contraindication for hyperbaric therapy (mid-ear pathology, abnormal chest x-ray, claustrophobia, pregnancy.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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

In the crossover set-up each of the participants took both DMSO (dimethyl sulfoxide, non-peptide solvent) and the comparison in turn, acting as their own control.

Everyone knew when DMSO (dimethyl sulfoxide, non-peptide solvent) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-02 with completion listed for 2015-03.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of DMSO (dimethyl sulfoxide, non-peptide solvent) in 60 people.

Its status is unknown; 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.

Our Notes on the Compound

DMSO (dimethyl sulfoxide, non-peptide solvent): A solvent that carries substances through skin and into the blood, described as a free-radical scavenger; not a peptide.

DMSO (dimethyl sulfoxide, non-peptide solvent) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.