OnabotulinumtoxinA Bladder Injection Study

NCT03523091 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2018-119
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with overactive bladder (OAB) will be randomly assigned (like a flip of a coin) to receive 100 units of onabotulinumtoxinA injected into the bladder at either 3 sites or 10 sites. Patient satisfaction and the effectiveness of the medication will be evaluated.

Conditions

Overactive Bladder; Overactive Bladder Syndrome; Urinary Urgency; Urinary Incontinence; Urinary Frequency/Urgency; Urinary Bladder, Overactive

Keywords

OnabotulinumtoxinA; Bladder Injections

Outcome Measures

Primary Outcomes (1)

• Number of Incontinence Episodes Per Day

  Participants will be asked to complete a 3-day voiding diary. On the diary participants will record the number of occurrences of voids over a 24 hour period for 3 consecutive days. Number of voids at 3 months are recorded.

  3 months after the initial injection

Secondary Outcomes (6)

• Degree of Bladder Symptom Bother

  3 months after the initial injection

• Severity of Urine Leakage

  3 months after the initial injection

• Change in Overactive Bladder Symptoms

  3 months after the initial injection

• Overall Patient Pain Tolerability With Treatment

  After the initial injection

• Overall Voiding Symptoms at 3 Months

  3 months after the initial injection

Study Arms (2)

3 Injection Sites

EXPERIMENTAL

OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder

Drug: OnabotulinumtoxinA 100Unit Injection

10 Injection Sites

EXPERIMENTAL

OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder

Drug: OnabotulinumtoxinA 100Unit Injection

Interventions

OnabotulinumtoxinA 100Unit Injection DRUG

Initial treatment with the option of repeat injections every 3 months

Also known as: Botox

10 Injection Sites; 3 Injection Sites

Eligibility Criteria

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

You may qualify if:

• Women and men, 18 years of age or older
• Self-reported failed conservative care of behavioral modifications and/or oral medications for the treatment of OAB
• Average urinary frequency of \> 8 voids per day as recorded on initial 3-day voiding diary
• Self-reported bladder symptoms \> 3 months
• Discontinued antimuscarinics/beta-3 agonists for \> 2 weeks prior to study enrollment. May restart antimuscarinics/beta-3 agonists if indicated \> 6 weeks after Botox injections.
• Capable of giving informed consent
• Capable and willing to follow all study-related procedures
• Previous OnabotulinumtoxinA injection at least three months prior to study enrollment.

You may not qualify if:

• Pregnant or planning to become pregnant during study duration
• Diagnosis of neurogenic bladder with the exception of highly functioning stroke patients
• If a patient has had a previous neuromodulation device placed, it will have to be turned off for 2 weeks for a washout period and remain off throughout the study
• Previous non-responders to onabotulinumtoxinA (BTX) therapy
• Patient cannot be receiving percutaneous nerve stimulation (PTNS) therapy. If patient is receiving PTNS, they need to stop for 1 month prior to entering the study.
• Refusal to self-catheterize or have indwelling catheter in the event of urinary retention
• Use of investigational drug/device therapy within past 4 weeks
• Participation in any clinical investigation involving or impacting gynecologic, urinary or renal function within past 4 weeks
• Current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation
• Pelvic radiation treatment
• Known hypersensitivity to OnabotulinumtoxinA.
• Previous infection at OnabotulinumtoxinA injection site.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; 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; Urination Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Jennifer Giordano
• Organization: William Beaumont Hospital

jennifer.giordano@beaumont.org

248-551-3517

Study Officials

• Larry Sirls, MD

  Beaumont Hospital-Royal Oak

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Urologist

Model Details: 2 arm parallel study with 1 to 1 randomization

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Study Start: August 8, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 10, 2022
• Results First Posted: February 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)