Local Anesthesia Before Bulkamid Injection

Stress Urinary Incontinence Clinical Trial

— LAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043063
• Other study ID #: STUDY00006172
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: April 2024

Study information

• Verified date: August 2023
• Source: Medstar Health Research Institute
• Contact: Neha G Gaddam, M.D.
• Phone: 832-865-0244
• Email: neha.g.gaddam[@]medstar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intrinsic Sphincter Deficiency
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• Topical lidocaine
Topical anesthetic
• EMLA cream
Topical anesthetic
• 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

Locations

Country	Name	City	State
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	MedStar Lafayette Medical Centre	Washington	District of Columbia
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ascertained at end of procedure (withdrawal of cystoscope)
Secondary	Duration of procedure	in seconds	Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope)
Secondary	Incomplete bladder emptying	Inability to void after procedure	Ascertained on day-of-procedure (within 1 hour of withdrawal of cystoscope)
Secondary	Need for re-injection of PAHG	Requirement for "top-off" or repeat injection due to persistent symptoms	Assessed at follow-up 2 weeks post-procedure
Secondary	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)	Assessed at baseline and at two-week and twelve-week follow-up visit
Secondary	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)	Assessed at two-week and twelve-week follow-up visit