Overactive Bladder Clinical Trial
Official title:
Minimizing Pain During Office Intradetrussor Botox Injection: A Prospective Randomized Controlled Trial Comparing Two Protocols
Verified date | July 2023 |
Source | Boston Urogynecology Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This will be a prospective double-blinded randomized controlled trial comparing two pre-treatment protocols for patients undergoing intradetrussor botox injections to determine if a buffered lidocaine solution offers superior pain control.
Status | Completed |
Enrollment | 72 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Female patient - Primary diagnosis of overactive bladder - Failed first and second line therapy for overactive bladder - Planning to undergo bladder botox injections Exclusion Criteria: - Neurogenic bladder - Urinary retention |
Country | Name | City | State |
---|---|---|---|
United States | Boston Urogynecology Associates | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Urogynecology Associates |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain: VAS | Pain on VAS | Immediately after the procedure | |
Secondary | Satisfaction: Likert scale | Likert scale questions assessing overall satisfaction with the procedure with responses from very dissatisfied to very satisfied | Immediately after the procedure | |
Secondary | Willingness to undergo repeat procedure | Likert scale questions assessing the patient's willingness to undergo a repeat procedure from very likely to very unlikely | Immediately after the procedure | |
Secondary | Adverse events | Urinary retention, defined as a post-void residual of greater than 100cc, will be assessed with a bladder scan at the two week post-procedure appointment | Immediately after the procedure, 2 weeks post treatment | |
Secondary | Pelvic Floor Distress Inventory (PFDI-20) Scores | baseline Pelvic Floor Distress Inventory (PFDI-20), scores range from 0-300 with higher scores representing higher symptom burden | Baseline, pre-procedure |
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