Botulin-A Toxin Instillations and Overactive Bladder

What Was Tested

The trial (phase 1, phase 2) is built around DMSO (dimethyl sulfoxide, non-peptide solvent).

It had 1 arm (groups): Botox/DMSO Solution (experimental).

The registry classes the interventions as drug.

More on the Plan

In recent years, cystoscopic-guided injection of Botulinum-A toxin has been used as a novel method of addressing detrusor hyperreflexia and overactivity by blocking acetylcholine transmission at the bladder.

Study Design: the researchers are proposing a single center, Phase II pilot study for this investigation.

The researchers will use two validated measurement tools for determining urinary incontinence severity.

These measurement tools will be administered to each women at baseline and then again at one month and three-month follow-up time points.

Who Took Part

25 actual participants took part.

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: Female patient aged 18 years or older. Patient with a history of stress urinary incontinence for at least 12 months. Patient with positive stress test and/or urodynamic stress incontinence. Patient who has failed prior non-invasive treatment (e.g. behavior modification, pelvic floor exercises, biofeedback, electrical stimulation and/or drug therapy). Patient with negative Contigen skin test during screening.

The full record lists 10 inclusion and 27 exclusion criteria; among the exclusions: patient with q-tip angle greater than 30 degrees; patient with vesicoureteral reflux, interstitial cystitis, genitourinary fistulae; patient with predominant urge incontinence.

How the Study Was Run

Design: single-group and open-label.

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.

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

It started in 2006-03 with completion listed for 2008-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Median Number of Incontinent Episodes During 24 Hours (time frame: baseline, 1 month, 3 months).

It also tracked 13 secondary outcomes, for example Median 24 Hour Pad Weight, Blaivas-Groutz Anti-Incontinence Score at Baseline, Blaivas-Groutz Anti-Incontinence Score at 1 Month, Blaivas-Groutz Anti-Incontinence Score at 3 Months, Mean Number of Pads Per Day and Postvoid Residual.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of DMSO (dimethyl sulfoxide, non-peptide solvent) in 25 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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