A Phase 1/2 interventional study of Botox 50 Unit Injection and Botox 100 Unit Injection in Overactive Bladder, Urinary Incontinence in Old Age and Urgency Urinary Incontinence, sponsored by Dartmouth-Hitchcock Medical Center. Active, not recruiting at 7 sites in United States. Open to female participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by Dartmouth-Hitchcock Medical Center · Phase 1/2, Interventional, and Treatment
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.
The purpose of this quadruple-masked, randomized-controlled study is to study the treatment of urgency urinary incontinence (UUI) specifically among older women with low- versus standard-dose of onabotulinumtoxinA (BTX) via: symptom-specific and health-related quality of life (QOL; Aim 1), patient-reported and clinical outcome measures including adverse events (Aim 2), qualitative experience with focused interviews (Aim 3) and cost burden and economic impact (Aim 4). This study is an active collaboration between researchers in Gynecology, Urology, and Geriatrics at Dartmouth Hitchcock Medical Center (DHMC) and at 6 other centers; University of Alabama (UAB), University of Pittsburgh (U Pitt), University of Texas Southwestern (UTSW), Kaiser Permanente of Southern California (KPSCP), Oregon Health \& Sciences University (OHSU), and University of Nebraska Medical Center (UNMC; joined January 2025). The investigators also have collaborators at Stanford University and University of Connecticut, though those sites are not recruiting participants.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's planned enrollment of 376 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Refractory urinary urgency incontinence, defined as
Exclusion Criteria:
The standard dose of 100 units of botox will be injected into the bladder.
Drug: Botox 100 Unit Injection
A lower dose of 50 units of botox will be injected into the bladder.
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.
Also known as: OnabotulinumtoxinA 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 injection up to twice during the 12 month follow-up period, with minimum 4 month intervals between treatments.
Also known as: OnabotulinumtoxinA 100 Unit
Change in symptom specific quality of life and bother over time.
The Overactive bladder questionnaire (OABq-SF), is a validated and reliable patient-centered quality of life questionnaire. The OABq-SF is based on a continuous sore of 0-100, with higher score translating to greater bother.
Time frame: Baseline, monthly post-injection through 12 months post-injection; primary outcome is at 3 months post-injection.
Symptom severity
Urogenital Distress Inventory (UDI-6). The UDI-6 has a cut off score of 33.33 to distinguish women who are symptomatic versus asymptomatic. UDI-6 scores that are greater than 33.33 indicated higher distress caused by urinary incontinence symptoms.
Time frame: Baseline, 3, 6, & 12 months post injection. Results will be compared at the end of the 12 months.
Symptom bother
Incontinence impact questionnaire (IIQ). The IIQ has a cut off score of 9.52. This score distinguish women who are symptomatic and asymptomatic.
Time frame: Baseline, 3, 6, & 12 months post injection. Results will be compared at the end of the 12 months.
Change in number of urgency urinary incontinence (UUI) episodes per day.
Participants will keep a bladder tally for 3 days and results will be compared from baseline to 1, 3, and 6 months post injected to determine if there has been a change in the number of urgency urinary incontinence episodes.
Time frame: Baseline, and 1, 3, and 6 months post injection
Change in Global Symptom Improvement
Participants will be asked to complete the Patient Global Impression of Improvement (PGI-I) scale. The PGI-I scale is a one item assessment with responses ranging from "very much better" to "very much worse".
Time frame: Baseline,3, 6, & 12 months post injection
Goal setting and attainment
Participants will express 3-5 goals and goal attainment will be assessed with the Patient Global Impression of Improvement Survey (PGI-I Scale). The PGI-I scale is a one item assessment with responses ranging from "very much better" to "very much worse".
Time frame: Baseline & 3 months post injection.
Change in general health-related quality of life as measure by the Health Utility Index-3
Participants will complete the Health Utilities Index (HUI). The HUI measure health status, reporting health-related quality of life, and producing utility scores. The score ranges from 0.00 (dead) to 1.00 (perfect health).
Time frame: Baseline, 3 6 and 12 months
Depression
Patient Health Questionnaire-9 (PHQ-9) is a 10 item scale with scores ranging from 1(minimal depression) to 27 (severe depression).
Time frame: Baseline, 3, 6 and 12 months post injection. Results will be compared at the end of the 3 month post injection.
Procedural discomfort and adverse events
Urinary retention, post-void residual \& duration of voiding dysfunction; urinary tract infection, unscheduled clinic/emergency department visits and any adverse events assessed using the Clavien-Dindo scale,which has been validated for use in urology setting.
Time frame: Day of injection and monthly through 12 months
Qualitative experience of BTX treatment and adverse events
Using novel focused interview for a subset of participants. Participants will be interviewed before injection and 3 months post injection.
Time frame: Baseline & 3 months post injection
Survey of economic burden
Incontinence Resource Use Questionnaire measures the amount of use of various incontinence products. Questions include the number of incontinence protection items used per week.
Time frame: Baseline, 3 & 12 months. Results will be compared at the end of the 12 months.
Plan to share: Yes — Yes, per PCORI data sharing policy. Details TBD.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center