Reduced-dose Botox for Urgency Incontinence Among Elder Females

Summary

The purpose of this study is to study the treatment of urgency urinary incontinence (UUI), specifically among women 70 years and older, by comparing reduced versus standard dose of onabotulinumtoxinA (BTX; trade name BOTOX(c)) injection in the bladder.

Conditions

• Overactive Bladder
• Urinary Incontinence in Old Age
• Urgency Urinary Incontinence

Interventions

DRUG

Botox 50 Unit Injection

Participants will be randomized to either receive a standard dose (100 units) or reduced dose (50 units) of onabotulinumtoxinA. If a participant has decreased symptom relief they may receive repeat treatment up to twice during the 12 month follow-up period, with minimum 4 month intervals between treatments.

DRUG

Botox 100 Unit Injection

Participants will be randomized to either receive a standard dose (100 units) or reduced dose (50 units) of onabotulinumtoxinA. If a participant has decreased symptom relief they may receive repeat injection up to twice during the 12 month follow-up period, with minimum 4 month intervals between treatments.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Dartmouth College

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Texas

  collaborator OTHER

• Kaiser Permanente

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Stanford University

  collaborator OTHER

• University of Connecticut

  collaborator OTHER

• University of Nebraska

  collaborator OTHER

• Dartmouth-Hitchcock Medical Center

  lead OTHER

Principal Investigators

• Anne C Cooper, MD, MA · Dartmouth-Hitchcock Medical Center

• E A Gormley, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-12

Primary Completion

2026-09-01

Completion

2027-01-01

FDA Drug

Yes

Countries

• United States

Study Locations