An interventional study of Topical lidocaine and EMLA cream in Stress Urinary Incontinence and Intrinsic Sphincter Deficiency, sponsored by Medstar Health Research Institute. Terminated at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Medstar Health Research Institute · Not applicable, Interventional, and Treatment
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 23 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Medstar Health Research Institute is the lead sponsor of 160 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min
Procedure: Topical lidocaine · Procedure: EMLA cream
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 lidocaine · Procedure: EMLA cream · Procedure: Periurethral block
Topical anesthetic
Also known as: Intraurethral 2% lidocaine gel
Topical anesthetic
Also known as: 2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream
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
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
Time frame: Ascertained at end of procedure (withdrawal of cystoscope)
Duration of procedure
in seconds
Time frame: Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope)
Incomplete bladder emptying
Inability to void after procedure
Time frame: Ascertained on day-of-procedure (within 1 hour of withdrawal of cystoscope)
Need for re-injection of PAHG
Requirement for "top-off" or repeat injection due to persistent symptoms
Time frame: Assessed at follow-up 2 weeks post-procedure
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)
Time frame: Assessed at baseline and at two-week and twelve-week follow-up visit
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)
Time frame: Assessed at two-week and twelve-week follow-up visit
Plan to share: No
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This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Medstar Health Research Institute