Overactive Bladder, Urgency Urinary Incontinence, Urinary Incontinence in Old Age
Conditions
Keywords
Urinary Incontinence, Urgency Urinary Incontinence, Overactive Bladder
Brief 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.
Detailed description
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.
Interventions
DRUGBotox 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.
DRUGBotox 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
Dartmouth-Hitchcock Medical Center
Patient-Centered Outcomes Research Institute
Dartmouth College
University of Alabama at Birmingham
University of Pittsburgh
University of Texas
Kaiser Permanente
Oregon Health and Science University
Stanford University
University of Connecticut
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult female at least 70 years old at date of enrollment 2. Urgency urinary incontinence (urge incontinence \> stress incontinence per screening criteria) 3. On average 2 or more urgency or insensible incontinence episodes per day per patient report 4. Refractory urinary urgency incontinence, defined as 1. Persistent symptoms despite trial of one or more conservative treatments (e.g. behavioral therapy, physical therapy, home Kegel exercises); participants not required to have attempted first line therapies if deemed not feasible or appropriate by provider with input of participant/caregiver. 2. Persistent symptoms despite the use of anticholinergic and/or beta-3 agonist medication; or inability to tolerate medication due to side effects, or has a contraindication to taking medication, or is unable to afford the cost of the medication. 5. Currently not on an anticholinergic or beta-3 agonist medication or is willing to stop medication for 3 weeks prior to completing baseline bladder tally, with plan to remain off medication through duration of the study. Currently not actively using sacral neuromodulation therapy (either has not tried, or unit has been off for 4 weeks prior to baseline bladder tally and will remain turned off for the duration of the study). It is permissible for participants to continue self-led conservative therapies during participation in the study, including Kegel exercises, avoidance of bladder irritants, and urge suppression. 6. Willing and able to complete all study-related items, with assistance of caregiver(s) if needed. 7. Demonstrates awareness of possible need for catheterization in event of post-injection urinary retention \& acknowledges risks of catheterization. Participant does not need to demonstrate ability to perform self-catheterization. 8. Grossly neurologically normal on exam and no gross systemic neurologic conditions believed to affect urinary function. Patients with a diagnosis of Parkinson's disease or diabetes may be eligible provided they have a grossly normal neurologic exam and otherwise fulfill the inclusion/
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptom specific quality of life and bother over time. | Baseline, monthly post-injection through 12 months post-injection; primary outcome is at 3 months post-injection. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom severity | Baseline, 3, 6, & 12 months post injection. Results will be compared at the end of the 12 months. | 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. |
| Symptom bother | Baseline, 3, 6, & 12 months post injection. Results will be compared at the end of the 12 months. | Incontinence impact questionnaire (IIQ). The IIQ has a cut off score of 9.52. This score distinguish women who are symptomatic and asymptomatic. |
| Change in number of urgency urinary incontinence (UUI) episodes per day. | Baseline, and 1, 3, and 6 months post injection | 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. |
| Change in Global Symptom Improvement | Baseline,3, 6, & 12 months post injection | 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". |
| Goal setting and attainment | Baseline & 3 months post injection. | 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". |
| Change in general health-related quality of life as measure by the Health Utility Index-3 | Baseline, 3 6 and 12 months | 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). |
| Depression | Baseline, 3, 6 and 12 months post injection. Results will be compared at the end of the 3 month post injection. | Patient Health Questionnaire-9 (PHQ-9) is a 10 item scale with scores ranging from 1(minimal depression) to 27 (severe depression). |
| Procedural discomfort and adverse events | Day of injection and monthly through 12 months | 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. |
| Qualitative experience of BTX treatment and adverse events | Baseline & 3 months post injection | Using novel focused interview for a subset of participants. Participants will be interviewed before injection and 3 months post injection. |
| Survey of economic burden | Baseline, 3 & 12 months. Results will be compared at the end of the 12 months. | Incontinence Resource Use Questionnaire measures the amount of use of various incontinence products. Questions include the number of incontinence protection items used per week. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnne C Cooper, MD, MA
Dartmouth-Hitchcock Medical Center
PRINCIPAL_INVESTIGATORE A Gormley, MD
Dartmouth-Hitchcock Medical Center
Outcome results
None listed