Reduced-dose Botox for Urgency Incontinence Among Elder Females

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

376

Participants

Timeline

Start Date

May 12, 2023

Primary Completion Date

September 1, 2026

Study Completion Date

January 1, 2027

Conditions
Overactive BladderUrinary Incontinence in Old AgeUrgency 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.

Trial Locations (7)

15213

RECRUITING

University of Pittsburgh Medical Center, Pittsburgh

35233

RECRUITING

University of Alabama - Birmingham, Birmingham

68198

RECRUITING

University of Nebraska Medical Center, Omaha

75390

RECRUITING

University of Texas Southwestern Medical Center, Dallas

92110

RECRUITING

Kaiser Permanente Medical Group, San Diego

97239

RECRUITING

Oregon Health & Science University, Portland

03766

RECRUITING

Dartmouth-Hitchcock Medical Center, Lebanon

All Listed Sponsors
collaborator

Patient-Centered Outcomes Research Institute

OTHER

collaborator

Dartmouth College

OTHER

collaborator

University of Alabama at Birmingham

OTHER

collaborator

University of Pittsburgh

OTHER

collaborator

University of Texas

OTHER

collaborator

Kaiser Permanente

OTHER

collaborator

Oregon Health and Science University

OTHER

collaborator

Stanford University

OTHER

collaborator

University of Connecticut

OTHER

collaborator

University of Nebraska

OTHER

lead

Dartmouth-Hitchcock Medical Center

OTHER