Phase 4
N=108
Procedural Discomfort Related to Number of Intradetrusor Botox Injections
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT05652036 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Participant Discomfort Related to BTX-A Injection — 3.2; 3.6 score on a scale — p=0.21
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Intradetrusor Botox Injections (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The Methodist Hospital Research Institute
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Discomfort Related to BTX-A Injection |
3.2; 3.6 | 0.21 |
| SECONDARY Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF) |
-22.4; -38.1; 14.59; 26.24 | .07 |
| SECONDARY Overall Treatment Satisfaction |
33; 34; 3; 9 | 0.21 |
| SECONDARY Impression of Clinical Improvement |
9; 9; 18; 16; 7; 15 | 0.79 |
| SECONDARY Procedural Outcomes |
0; 2; 5; 2; 0; 0 | 0.5 |
Summary
Injection of intradetrusor OnabotulinumtoxinA (BTX-A) is a highly efficacious therapy with a reliable safety profile and demonstrable improvements in subjective and objective measures for overactive bladder (OAB) symptom control. This procedure can be performed in the office with an evidence-based standard dosing of 100 units for idiopathic OAB. This is a single-blinded, randomized control trial is to evaluate and optimize the technique for performing intradetrusor injections of BTX-A for idiopathic OAB. This trial proposes two different reconstitution and injection schema to study patient-centered outcomes related to procedural discomfort and symptom relief.
Eligibility Criteria
Inclusion Criteria
- Women scheduled to undergo 100 units intradetrusor BTX-A injections in the office for the diagnosis of idiopathic overactive bladder within the departments of Urology and Urogynecology
- 18 years of age or older
- Able to give informed consent in English or Spanish
- Understand and are willing to undergo follow-up and complete all questionnaires as described in this protocol
Exclusion Criteria
- Neurogenic bladder related to prior diagnosis of neurological conditions such as cerebral vascular accident within 6 months prior to treatment, Parkinson's Disease, Multiple Sclerosis, myelomeningocele, traumatic neurologic or spinal injury, or idiopathic diagnosis of neurogenic bladder.
- Symptomatic UTI at the time of procedure, defined as positive nitrites or high-volume leukocyte esterase on urine dip in addition to at least one of the following symptoms: dysuria, gross hematuria, suprapubic pain, frequency/urgency above baseline
- Diagnosis of a bladder pain syndrome or other chronic pain syndromes including fibromyalgia, chronic pelvic pain, pelvic floor dysfunction, levator myalgia
- Known bladder malignancy
- Previous history of bladder augmentation or reconstructive surgery not related to prolapse
Data sourced from ClinicalTrials.gov (NCT05652036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.