Local Anesthesia Before Bulkamid Injection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-12-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Stress Urinary Incontinence Intrinsic Sphincter Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Topical anesthesia alone

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

Group Type EXPERIMENTAL

Topical lidocaine

Intervention Type PROCEDURE

Topical anesthetic

EMLA cream

Intervention Type PROCEDURE

Topical anesthetic

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

Group Type ACTIVE_COMPARATOR

Topical lidocaine

Intervention Type PROCEDURE

Topical anesthetic

EMLA cream

Intervention Type PROCEDURE

Topical anesthetic

Periurethral block

Intervention Type PROCEDURE

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

Interventions

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Topical lidocaine

Topical anesthetic

Intervention Type PROCEDURE

EMLA cream

Topical anesthetic

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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Intraurethral 2% lidocaine gel 2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream 1% lidocaine or 0.25% bupivacaine

Eligibility Criteria

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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

Exclusion Criteria

* Pregnancy
* Neurogenic bladder
* Pre-existing need for intermittent catheterization or indwelling catheter
* Bladder or urothelial malignancy
* Prior radiation to pelvic floor
* Known allergy/sensitivity to PAHG

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No