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Neurotoxin

Botox and DMSO instillation for Urinary Incontinence

Phase 3
Waitlist Available
Led By Steven P Petrou, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 months
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved

Summary

The purpose of this study is to determine whether women with overactive bladder (OAB) who receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms when compared to a similar group of women with OAB who receive instillation of DMSO only.

Eligible Conditions
  • Overactive Bladder
  • Urinary Incontinence
  • Urge Incontinence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Incontinence Quality of Life (I-QoL) Score
Secondary study objectives
Change in Incontinence Impact Questionnaire Short Form (IIQ-7)
Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF)
Change in Urogenital Distress Inventory (UDI-6)
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Botox and DMSO instillationExperimental Treatment2 Interventions
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Group II: DMSO instillationPlacebo Group1 Intervention
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,326 Previous Clinical Trials
3,059,469 Total Patients Enrolled
4 Trials studying Urinary Incontinence
151 Patients Enrolled for Urinary Incontinence
Steven P Petrou, MDPrincipal InvestigatorMayo Clinic
~1 spots leftby Nov 2025
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