Trial Comparing Intravesical Cocktail With Intravesical Dimethyl Sulfoxide (DMSO) in Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC)

What Was Tested

The trial (phase 2) is built around DMSO (dimethyl sulfoxide, non-peptide solvent).

It had two arms (groups): DMSO (active comparator) and Cocktail (experimental).

Intravesical installation.

The registry classes the interventions as drug.

Who Took Part

10 actual participants took part.

It was open to people of any sex 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: Participants should be of age eighteen years or older. Participant has painful bladder syndrome and a score of 8 or greater on the painful bladder syndrome symptom index (O'Leary-Sant). Participant should have frequency and urgency of micturition and bladder pain for at least 6 months. Participant should have voids at least 8 times during a 24 hour period and at least once during the night as documented in the voiding diary and questionnaire. Urine culture should not show any evidence of urinary tract infection.

The full record lists 9 inclusion and 20 exclusion criteria; among the exclusions: participants who have undergone cystoscopy within 4 weeks of screening visit; participants had other treatment given into the bladder in the past 4 weeks; participants have used a new drug in the past 4 weeks which could affect bladder symptoms (some antidepressants, anticholinergics, antihistamines).

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The participants were allocated by chance, so the DMSO (dimethyl sulfoxide, non-peptide solvent) group and the comparison group should start out alike.

The DMSO (dimethyl sulfoxide, non-peptide solvent) group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether DMSO (dimethyl sulfoxide, non-peptide solvent) was given.

Those kept unaware of assignments: participant.

It started in 2006-04 with completion listed for 2009-02.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of DMSO (dimethyl sulfoxide, non-peptide solvent) in 10 people.

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

It ended early (terminated); 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.