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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical anesthesia alone | Experimental | 2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical lidocaine | Procedure | Topical anesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of procedure | in seconds | Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope) |
| Incomplete bladder emptying | Inability to void after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States | ||
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| EMLA cream | Procedure | Topical anesthetic |
|
|
| Periurethral block | Procedure | 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 |
|
|
| 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 | 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) | 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) | Assessed at two-week and twelve-week follow-up visit |
| MedStar Washington Hospital Center |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| MedStar Lafayette Medical Centre | Washington D.C. | District of Columbia | 20036 | United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D011318 | Prilocaine |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |