LAB: Local Anesthesia Before Bulkamid Injection

Sponsor

Medstar Health Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06043063

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence Intrinsic Sphincter Deficiency	Procedure: Topical lidocaine Procedure: EMLA cream Procedure: Periurethral block	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Post-procedural Pain Associated With Periurethral Block at Time of Bulkamid Injection for SUI: a Randomized Controlled Trial

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Topical anesthesia alone 2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min	Procedure: Topical lidocaine Topical anesthetic Other Names: Intraurethral 2% lidocaine gel Procedure: EMLA cream Topical anesthetic Other Names: 2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream
Active Comparator: Topical anesthesia with periurethral block 2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min + periurethral block (5 cc 1% lidocaine or 0.25% bupivacaine at 3 and 9 o'clock to depth of 1.5 cm using 25G needle) Block sits for 5 min if lidocaine, 10 min if bupivacaine	Procedure: Topical lidocaine Topical anesthetic Other Names: Intraurethral 2% lidocaine gel Procedure: EMLA cream Topical anesthetic Other Names: 2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream 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 Other Names: 1% lidocaine or 0.25% bupivacaine

Arm

Intervention/Treatment

Experimental: Topical anesthesia alone

2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min

Procedure: Topical lidocaine

Topical anesthetic

Other Names:

Intraurethral 2% lidocaine gel

Procedure: EMLA cream

Topical anesthetic

Other Names:

2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream

Active Comparator: Topical anesthesia with periurethral block

2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min + periurethral block (5 cc 1% lidocaine or 0.25% bupivacaine at 3 and 9 o'clock to depth of 1.5 cm using 25G needle) Block sits for 5 min if lidocaine, 10 min if bupivacaine

Procedure: Topical lidocaine

Topical anesthetic

Other Names:

Intraurethral 2% lidocaine gel

Procedure: EMLA cream

Topical anesthetic

Other Names:

2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream

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

Other Names:

1% lidocaine or 0.25% bupivacaine

Outcome Measures

Primary Outcome Measures

Visual analog scale (VAS) for pain [Ascertained at end of procedure (withdrawal of cystoscope)]
Visual analog scale for pain uses a scale from 0-10 corresponding to reported pain levels with 0 indicating no pain and 10 indicating most severe pain possible

Secondary Outcome Measures

Duration of procedure [Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope)]
in seconds
Incomplete bladder emptying [Ascertained on day-of-procedure (within 1 hour of withdrawal of cystoscope)]
Inability to void after procedure
Need for re-injection of PAHG [Assessed at follow-up 2 weeks post-procedure]
Requirement for "top-off" or repeat injection due to persistent symptoms
International Consultation on Incontinence Questionnaire for Urinary Incontinence (ICIQ-UI) [Assessed at baseline and at two-week and twelve-week follow-up visit]
3 items on frequency/quantity of leakage and impact on quality on life (range 0-21 with lower score indicating lower severity of incontinence symptoms and higher score indicating higher severity of incontinence symptoms)
Patient Global Impression of Improvement scale (PGI-I) [Assessed at two-week and twelve-week follow-up visit]
1 item on relative change in symptoms following treatment (range 1-7 with lower score indicating greater improvement in incontinence symptoms following intervention and higher score indicating lower improvement in incontinence following intervention)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women ≥ 18 years old with stress urinary incontinence, intrinsic sphincter deficiency, or stress-predominant mixed urinary incontinence desiring PAHG
English-speaking
Scheduled in outpatient clinic or OR without sedation, general, or neuraxial anesthesia