DMSO Efficacy in IC/PBS Patients During and After Treatment

Plain-language guide to NCT01074567: not phased interventional trial of DMSO (dimethyl sulfoxide, non-peptide solvent), 50 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01074567
Phase: not phased
Status: status unknown
Start: 2009-12
Completion (planned or actual): 2011-12
Participants: 50 (estimated)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Cystitis, Interstitial
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 1 arm (groups): DMSO cocktail (experimental).

The registry classes the interventions as drug.

More on the Plan

The modern treatment of IC is a multi-modal treatment which includes behavioural treatment, physiotherapy of the pelvic floor musculature, oral medication (e.g.

Amitryptiline) and intra-vesical instillation (e.g.

However, the optimal duration of intra-vesical instilation is not known.

All patients with IC (according to the international continence society criteria) will receive 12 weekly intra-vesical instillation of DMSO.

Who Took Part

Enrollment: 50 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Patients with IC according to International Continence Society:. More than 6 month of pelvic pain. Urinary frequency, urgency, dyspareunia.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: genitourinary tract infection; known genitourinary malformation.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the DMSO (dimethyl sulfoxide, non-peptide solvent) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-12 with completion listed for 2011-12.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: O'leary-Sant interstitial cystitis symptom and problem questionaire (time frame: before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment).

It also tracked 1 secondary outcome, for example urination diary.

What This Means in Plain Language

Put simply, this is a not phased trial of DMSO (dimethyl sulfoxide, non-peptide solvent) in 50 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.