Recruiting

Oral vs. Intravesical

Sponsor:

Women and Infants Hospital of Rhode Island

Code:

NCT03755089

Conditions

Overactive Bladder Syndrome

Urge Incontinence

Urinary Incontinence

Detrusor Hyperreflexia

Detrusor Instability

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Phenazopyridine

Lidocaine 2% Injectable Solution

Study Details

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

Study ID

NCT03755089

Start date

Nov 1, 2018

Status verified date

May, 2020

Completion date

Mar 1, 2021

Anticipated

Primary completion date

Mar 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Primary language other than English or Spanish

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Oral Phenazopyridine

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

active comparator: Intravesical Lidocaine

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.

Interventions

Phenazopyridine

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

Lidocaine 2% Injectable Solution

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

Primary outcome measure

  • Analgesic Effect Measured with 100mm Visual Analog Scale [ Time Frame: Immediately post-procedure ]

Central Contacts and Locations

Central contacts

Lauren E Stewart, MD

401-453-7560lstewart@wihri.org

Locations

Women & Infants Hospital of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Lauren E Stewart, MD

401-453-7560lstewart@wihri.org

More Information

Sponsor

Women and Infants Hospital of Rhode Island

Last update posted

May 29, 2020

Last verified

May, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2020-05-29.