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Local Anesthesia Before Bulkamid Injection (LAB)

Primary Purpose

Stress Urinary Incontinence, Intrinsic Sphincter Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Topical lidocaine
EMLA cream
Periurethral block
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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 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

Sites / Locations

  • MedStar Georgetown University HospitalRecruiting
  • MedStar Washington Hospital CenterRecruiting
  • MedStar Lafayette Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Topical anesthesia alone

Topical anesthesia with periurethral block

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual analog scale (VAS) for pain
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
in seconds
Incomplete bladder emptying
Inability to void after procedure
Need for re-injection of PAHG
Requirement for "top-off" or repeat injection due to persistent symptoms
International Consultation on Incontinence Questionnaire for Urinary Incontinence (ICIQ-UI)
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)
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)

Full Information

First Posted
August 31, 2023
Last Updated
September 25, 2023
Sponsor
Medstar Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT06043063
Brief Title
Local Anesthesia Before Bulkamid Injection
Acronym
LAB
Official Title
Post-procedural Pain Associated With Periurethral Block at Time of Bulkamid Injection for SUI: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Intrinsic Sphincter Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topical anesthesia alone
Arm Type
Experimental
Arm Description
2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min
Arm Title
Topical anesthesia with periurethral block
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Topical lidocaine
Other Intervention Name(s)
Intraurethral 2% lidocaine gel
Intervention Description
Topical anesthetic
Intervention Type
Procedure
Intervention Name(s)
EMLA cream
Other Intervention Name(s)
2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream
Intervention Description
Topical anesthetic
Intervention Type
Procedure
Intervention Name(s)
Periurethral block
Other Intervention Name(s)
1% lidocaine or 0.25% bupivacaine
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual analog scale (VAS) for pain
Description
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
Time Frame
Ascertained at end of procedure (withdrawal of cystoscope)
Secondary Outcome Measure Information:
Title
Duration of procedure
Description
in seconds
Time Frame
Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope)
Title
Incomplete bladder emptying
Description
Inability to void after procedure
Time Frame
Ascertained on day-of-procedure (within 1 hour of withdrawal of cystoscope)
Title
Need for re-injection of PAHG
Description
Requirement for "top-off" or repeat injection due to persistent symptoms
Time Frame
Assessed at follow-up 2 weeks post-procedure
Title
International Consultation on Incontinence Questionnaire for Urinary Incontinence (ICIQ-UI)
Description
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)
Time Frame
Assessed at baseline and at two-week and twelve-week follow-up visit
Title
Patient Global Impression of Improvement scale (PGI-I)
Description
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)
Time Frame
Assessed at two-week and twelve-week follow-up visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neha G Gaddam, M.D.
Phone
832-865-0244
Email
neha.g.gaddam@medstar.net
First Name & Middle Initial & Last Name or Official Title & Degree
Neha G Gaddam, M.D.
Phone
832-865-0244
Email
gaddam.ng@gmail.com
Facility Information:
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neha G Gaddam, MD
Phone
832-865-0244
Email
neha.g.gaddam@medstar.net
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neha G Gaddam, MD
Phone
832-865-0244
Email
neha.g.gaddam@medstar.net
Facility Name
MedStar Lafayette Medical Centre
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neha G Gaddam, MD
Phone
832-865-0244
Email
neha.g.gaddam@medstar.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Local Anesthesia Before Bulkamid Injection

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