Oral vs Intravesical Analgesia for Office Bladder Botox Injections

NCT03755089 | Unknown Phase 4 FDA Drug

• 1 other identifier: 1258364-2
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

OnabotulinumtoxinA (Botox®) bladder injections are a highly effective treatment for overactive bladder and urgency urinary incontinence. The procedure is typically performed in the office setting with one of two medications to control comfort. However, the effectiveness of these medications has never been compared. The goal of this study is to determine which medication is better at providing comfort during bladder Botox® injections.

Conditions

Overactive Bladder Syndrome; Urge Incontinence; Urinary Incontinence; Detrusor Hyperreflexia; Detrusor Instability

Outcome Measures

Primary Outcomes (1)

• Analgesic Effect Measured with 100mm Visual Analog Scale

  The visual analog scale is a visual representation of pain severity rated from 0 (no pain) to 10 (worst pain imaginable). Therefore higher numbers represent more pain.The scale is represented visually using a 100 millimeter line and patients indicate their level of pain by pointing to a location on the line.

  Immediately post-procedure

Secondary Outcomes (3)

• Overall Patient Satisfaction

  Immediately post-procedure

• Ease of Procedure

  Immediately post-procedure

• Office Efficiency/Total Appointment Duration

  Immediately post-procedure

Study Arms (2)

Oral Phenazopyridine

ACTIVE COMPARATOR

Patients randomized to the oral phenzopyridine arm will receive 200mg phenazopyridine to take by mouth 1-2 hours before their scheduled procedure.

Drug: Phenazopyridine

Intravesical Lidocaine

ACTIVE COMPARATOR

Patients randomized to the intravesical lidocaine arm will have the bladder back-filled with 30mL 2% lidocaine for the 20 minutes immediately preceding their procedure.

Drug: Lidocaine 2% Injectable Solution

Interventions

Phenazopyridine DRUG

200mg PO Phenazopyridine taken 1-2 hours prior to the Botox® injection procedure

Oral Phenazopyridine

Lidocaine 2% Injectable Solution DRUG

30mL 2% lidocaine instilled into the bladder lumen 20 via a urinary catheter 20 minutes prior to the Botox® injection procedure

Intravesical Lidocaine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-pregnant, adult females 18 years of age or older
• Diagnosis of idiopathic overactive bladder
• Planning office-based bladder injection of onabotulinumtoxinA
• Willing and able to complete all study related items and interviews
• Grossly neurologically normal on exam

You may not qualify if:

• Known neurologic diseases (multiple sclerosis, Parkinson Disease, CVA within 6 months, myasthenia gravis, Charcot-Marie-Tooth disease, peripheral neuropathy, and complete spinal cord injury) believed to affect urinary function
• Planned injection of \>100 units of onabotulinumtoxinA
• OnabotulinumtoxinA given for another indication within the previous 3 months (if cumulative dose would total \>400 units)
• Any intradetrusor onabotulinumtoxinA injections in the previous 12 months
• Serum creatinine level greater than twice the upper limit of normal within the year prior to enrollment
• Allergy to lidocaine
• Allergy to onabotulinumtoxinA
• Allergy to phenazopyridine
• Untreated urinary tract infection (UTI)
• Currently pregnant or lactating.
• Known urinary retention (post-void residual \>200mL) and inability to perform intermittent self-catheterization
• Uninvestigated hematuria (gross or microscopic)
• Current or prior bladder malignancy
• Previous bladder augmentation or surgically altered detrusor muscle
• Prior pelvic radiation

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (1)

• Stewart LE, Siddique M, Jacobs KM, Raker CA, Sung VW. Oral phenazopyridine vs intravesical lidocaine for bladder onabotulinumtoxinA analgesia: a randomized controlled trial. Am J Obstet Gynecol. 2022 Aug;227(2):308.e1-308.e8. doi: 10.1016/j.ajog.2022.05.025. Epub 2022 May 14.

  PMID: 35580634 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Incontinence; Urinary Bladder, Overactive

Interventions

Phenazopyridine; Lidocaine

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Lauren E Stewart, MD

  Women and Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren E Stewart, MD

CONTACT

401-453-7560; lstewart@wihri.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 27, 2018
• Study Start: November 1, 2018
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)