Over Active Bladder Instillation Study - Botox

What Was Tested

This registered phase 3 trial tested DMSO (dimethyl sulfoxide, non-peptide solvent).

It had two arms (groups): Botox and DMSO instillation (experimental) and DMSO instillation (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Their long-term goal is to offer women with detrusor hyperreflexia or OAB a less invasive alternative to surgery and an alternative to anticholinergic by mouth medications.

Note: The study was terminated early in July of 2011 due to an extended medical absence of the Principal Investigator.

Who Took Part

The registry lists 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. No evidence of stress urinary incontinence on physical examination or urodynamics. Patients who have failed prior drug therapy for overactive bladder or detrusor hyperreflexia. Patients with symptoms and signs of OAB, detrusor hyperreflexia, urinary urgency, urinary urge incontinence. Patient who is mentally competent with the ability to understand and comply with the requirements of the study.

The full record lists 7 inclusion and 19 exclusion criteria; among the exclusions: patient with greater than vesicoureteral reflux grade 1, interstitial cystitis, genitourinary fistulae; patient with un-investigated hematuria; patient with lower tract genitourinary malignancies.

How the Study Was Run

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

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

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

As a double-blind DMSO (dimethyl sulfoxide, non-peptide solvent) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2008-04 with completion listed for 2012-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Incontinence Quality of Life (I-QoL) Score (time frame: Baseline, 1 month, 3 months).

It also tracked 5 secondary outcomes, for example Change in Incontinence Impact Questionnaire Short Form (IIQ-7), Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF) and Change in Urogenital Distress Inventory (UDI-6).

What This Means in Plain Language

Put simply, this is a phase 3, randomized 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.

It ended early (terminated); 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.