Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
University of South Florida
Study ID
NCT04305743
Phase
PHASE4
Status
Recruiting
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Conditions

  • Incontinence, Urge
  • Incontinence, Urinary
  • Nocturia
  • Urinary Bladder, Overactive
  • Urinary Frequency More Than Once at Night
  • Urinary Urge Incontinence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OnabotulinumtoxinA 100 UNT — DRUG
    Intradetrusor onabotulinumtoxin A is administered cystoscopically with 100 unit dose given as either 5 or 20 injections in a single procedure based on the arm the participant is randomized into.

Study Details

Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.

Key Dates

Start date
Oct 9, 2019
Status verified
Nov 2020
Primary completion
Jan 1, 2021
Completion
Jun 1, 2021

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 5 Injections
    Participant's bladder is backfilled with 50 mL of 1% lidocaine for 15 minutes, then drained prior to procedure start. Dose of 100 units onabotulinumtoxin A with dilution to 100 Units/10 mL with preservative-free 0.9% Sodium Chloride Injection is prepared. Cystoscopy is performed. The 23 gauge Laborie InjeTAK needle is inserted 3 mm into the detrusor. 5 injections of 2 mL each (total volume of 10 mL) in a single procedure is performed 1 cm apart in the bladder body. For the final injection, approximately 1 mL of sterile normal saline should be injected such that the remaining onabotulinumtoxin A in the needle is delivered to the bladder.
  • Active Comparator: 20 Injections
    Participant's bladder is backfilled with 50 mL of 1% lidocaine for 15 minutes, then drained prior to procedure start. Dose of 100 units onabotulinumtoxin A with dilution to 100 Units/10 mL with preservative-free 0.9% Sodium Chloride Injection is prepared. Cystoscopy is performed. The 23 gauge Laborie InjeTAK needle is inserted 3 mm into the detrusor. 20 injections of 0.5 mL each (total volume of 10 mL) in a single procedure is performed 1 cm apart in the bladder body. For the final injection, approximately 1 mL of sterile normal saline should be injected such that the remaining onabotulinumtoxin A in the needle is delivered to the bladder.

Primary Outcome Measure

Pain from procedure: score [ Time Frame: Within 5 minutes of procedure completion ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Nancy Ringel, MD
[email protected]
Amy Park, MD (SUB_INVESTIGATOR)
Cheryl Iglesia, MD (SUB_INVESTIGATOR)
Nancy Ringel, MD (PRINCIPAL_INVESTIGATOR)
University of South Florida Health South Tampa Center for Advanced HealthcareTampaFlorida33606
Eric S Chang, MD
[email protected]
813-259-8500
Allison Wyman, MD
[email protected]
813-259-8500
Isabel Prieto, MD (SUB_INVESTIGATOR)
Ryan Hidalgo, MD (SUB_INVESTIGATOR)
Renee Bassaly, DO (SUB_INVESTIGATOR)
Kristie Greene, MD (SUB_INVESTIGATOR)
Allison Wyman, MD (SUB_INVESTIGATOR)
Eric S Chang, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By research site
MedStar Washington Hospital Center· Washington D.C., DCUniversity of South Florida Health South Tampa Center for Advanced Healthcare· Tampa, FL

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