NCT06043063

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2024

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

August 31, 2023

Last Update Submit

May 13, 2025

Conditions

Stress Urinary IncontinenceIntrinsic Sphincter Deficiency

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Duration of procedure

    Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope)

  • Incomplete bladder emptying

    Ascertained on day-of-procedure (within 1 hour of withdrawal of cystoscope)

  • Need for re-injection of PAHG

    Assessed at follow-up 2 weeks post-procedure

  • International Consultation on Incontinence Questionnaire for Urinary Incontinence (ICIQ-UI)

    Assessed at baseline and at two-week and twelve-week follow-up visit

  • Patient Global Impression of Improvement scale (PGI-I)

    Assessed at two-week and twelve-week follow-up visit

Study Arms (2)

Topical anesthesia alone

EXPERIMENTAL

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

Procedure: Topical lidocaineProcedure: EMLA cream

Topical anesthesia with periurethral block

ACTIVE COMPARATOR

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 lidocaineProcedure: EMLA creamProcedure: Periurethral block

Interventions

Topical lidocainePROCEDURE

Topical anesthetic

Also known as: Intraurethral 2% lidocaine gel
Topical anesthesia aloneTopical anesthesia with periurethral block
EMLA creamPROCEDURE

Topical anesthetic

Also known as: 2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream
Topical anesthesia aloneTopical anesthesia with periurethral block
Periurethral blockPROCEDURE

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

Also known as: 1% lidocaine or 0.25% bupivacaine
Topical anesthesia with periurethral block

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MedStar Lafayette Medical Centre

Washington D.C., District of Columbia, 20036, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

LidocaineLidocaine, Prilocaine Drug CombinationBupivacaine

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPrilocaineDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 21, 2023

Study Start

September 1, 2023

Primary Completion

August 16, 2024

Study Completion

December 23, 2024

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)