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Local Anesthesia Before Bulkamid Injection

NCT06043063 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-05-16

No results posted yet for this study

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

  • Stress Urinary Incontinence
  • Intrinsic Sphincter Deficiency

Interventions

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

Sponsors & Collaborators

  • Medstar Health Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-08-16
Completion
2024-12-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06043063 on ClinicalTrials.gov