TerminatedNot Applicable

Local Anesthesia Before Bulkamid Injection

Stopped: Study was terminated prematurely due to meeting safety endpoint defined as 3 participants in the experimental arm requiring termination of in-office procedure due to pain.

United States23 participantsStarted 2023-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual analog scale (VAS) for pain

Timeframe: Ascertained at end of procedure (withdrawal of cystoscope)

Trial details

NCT IDNCT06043063

SponsorMedstar Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-16

View on ClinicalTrials.gov More Stress Urinary Incontinence trials