Local Anesthesia Before Bulkamid Injection (LAB)
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| ClinicalTrials.gov Identifier: NCT06043063 |
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Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : September 28, 2023
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Sponsor:
Medstar Health Research Institute
Information provided by (Responsible Party):
Medstar Health Research Institute
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stress Urinary Incontinence Intrinsic Sphincter Deficiency | Procedure: Topical lidocaine Procedure: EMLA cream Procedure: Periurethral block | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 52 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Post-procedural Pain Associated With Periurethral Block at Time of Bulkamid Injection for SUI: a Randomized Controlled Trial |
| Actual Study Start Date : | September 1, 2023 |
| Estimated Primary Completion Date : | April 2024 |
| Estimated Study Completion Date : | April 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Urinary Incontinence
| Arm | Intervention/treatment |
|---|---|
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Experimental: Topical anesthesia alone
2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min
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Procedure: Topical lidocaine
Topical anesthetic
Other Name: Intraurethral 2% lidocaine gel Procedure: EMLA cream Topical anesthetic
Other Name: 2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream |
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Active Comparator: Topical anesthesia with periurethral block
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
Topical anesthetic
Other Name: Intraurethral 2% lidocaine gel Procedure: EMLA cream Topical anesthetic
Other Name: 2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream Procedure: 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
Other Name: 1% lidocaine or 0.25% bupivacaine |
Primary Outcome Measures :
- Visual analog scale (VAS) for pain [ Time Frame: Ascertained at end of procedure (withdrawal of cystoscope) ]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
Secondary Outcome Measures :
- Duration of procedure [ Time Frame: Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope) ]in seconds
- Incomplete bladder emptying [ Time Frame: Ascertained on day-of-procedure (within 1 hour of withdrawal of cystoscope) ]Inability to void after procedure
- Need for re-injection of PAHG [ Time Frame: Assessed at follow-up 2 weeks post-procedure ]Requirement for "top-off" or repeat injection due to persistent symptoms
- International Consultation on Incontinence Questionnaire for Urinary Incontinence (ICIQ-UI) [ Time Frame: Assessed at baseline and at two-week and twelve-week follow-up visit ]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)
- Patient Global Impression of Improvement scale (PGI-I) [ Time Frame: Assessed at two-week and twelve-week follow-up visit ]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)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043063
Contacts
| Contact: Neha G Gaddam, M.D. | 832-865-0244 | neha.g.gaddam@medstar.net | |
| Contact: Neha G Gaddam, M.D. | 832-865-0244 | gaddam.ng@gmail.com |
Locations
| United States, District of Columbia | |
| MedStar Georgetown University Hospital | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Neha G Gaddam, MD 832-865-0244 neha.g.gaddam@medstar.net | |
| MedStar Washington Hospital Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Neha G Gaddam, MD 832-865-0244 neha.g.gaddam@medstar.net | |
| MedStar Lafayette Medical Centre | Recruiting |
| Washington, District of Columbia, United States, 20036 | |
| Contact: Neha G Gaddam, MD 832-865-0244 neha.g.gaddam@medstar.net | |
Sponsors and Collaborators
Medstar Health Research Institute
| Responsible Party: | Medstar Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT06043063 |
| Other Study ID Numbers: |
STUDY00006172 |
| First Posted: | September 21, 2023 Key Record Dates |
| Last Update Posted: | September 28, 2023 |
| Last Verified: | August 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Lower Urinary Tract Symptoms Urological Manifestations Lidocaine Bupivacaine Anesthetics, Local |
Lidocaine, Prilocaine Drug Combination Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anesthetics, Combined |