Trials / Terminated
TerminatedNCT06043063
Local Anesthesia Before Bulkamid Injection
Post-procedural Pain Associated With Periurethral Block at Time of Bulkamid Injection for SUI: a Randomized Controlled Trial
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Medstar Health Research Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
While recommended pre-anesthesia for polyacylamide hydrogel (PAHG, Bulkamid) injections for stress urinary incontinence and intrinsic sphincter deficiency can include intraurethral anesthetic gel with or without periurethral block, there is no existing literature to guide choice of anesthesia. This is a single-blinded randomized control trial to evaluate post-procedure pain with choice of anesthesia before PAHG injection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Topical lidocaine | Topical anesthetic |
| PROCEDURE | EMLA cream | Topical anesthetic |
| PROCEDURE | Periurethral block | 5 cc 1% lidocaine or 0.25% bupivacaine at 3 and 9 o'clock (periurethral tissues) to depth of 1.5 cm using 25G needle |
Timeline
- Start date
- 2023-09-01
- Primary completion
- 2024-08-16
- Completion
- 2024-12-23
- First posted
- 2023-09-21
- Last updated
- 2025-05-16
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06043063. Inclusion in this directory is not an endorsement.