Intradetrusor Botulinum Toxin A for OAB Via 1 Versus 10 Injections: A Randomized Clinical Trial

NCT05308979 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 309
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with either overactive bladder (OAB) or urgency urinary incontinence (UUI) with be randomized (like a flip of a coin) to receive 100 units of bladder Botox® at either one injection site or ten injection sites. Efficacy and patient satisfaction will be measured by questionnaires.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Overactive Bladder Questionnaire Long Form Score (Symptoms Severity Sub-scale)(OAB-Q LF)

  Participants will be asked to Overactive Bladder Questionnaire Long Form prior to receiving the Botox procedure. The OAB-Q LF symptom severity sub-scale score will be compared prior to procedure and again to score at 3 weeks after procedure. The OAB-q Symptom Severity Score will be computed at baseline and 3 weeks (and 3 months) using the standard scoring algorithm. Minimum value of symptom severity subscale is 8, maximum is 48. A higher score means worse symptoms. A lower score means less symptoms.

  change from baseline OAB-Q score to 3 wk post-procedure score

Secondary Outcomes (5)

• Change in Overactive Bladder Questionnaire Long Form Score (Health Related Quality of Life)(OAB-Q LF HRQL Subscale)

  comparison of baseline OAB-Q HRQL score to 3 month post-procedure score

• Post-void Residual (PVR)

  PVR collected at 3 wk post-procedure

• Number of Participants With Urinary Tract Infection (UTI)

  anytime after procedure, until at least 3 months post-procedure.

• Number of Patients With Patient Global Impression - Improvement (PGI-I) Score of 1

  3 months after botox procedure

• Visual Analogue Scale (VAS) - Pain

  immediately after procedure

Study Arms (2)

1 Injection Site

EXPERIMENTAL

100u Botox® injected at one intradetrusor site

Drug: OnabotulinumtoxinA 100 UNT [Botox]

10 Injection Sites

ACTIVE COMPARATOR

100u Botox® injected at 10 intradetrusor sites

Drug: OnabotulinumtoxinA 100 UNT [Botox]

Interventions

OnabotulinumtoxinA 100 UNT [Botox] DRUG

Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites

1 Injection Site; 10 Injection Sites

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• years old or greater
• Diagnosis of overactive bladder (urinary urgency or frequency, OAB) or urinary urgency incontinence (UUI)

You may not qualify if:

• Have a diagnosis of neurogenic bladder
• Received intravesical botox injections within prior 6 months
• Current treatment with either: SNM, PTNS, or OAB medications - need wash out as below
• SNM - turn device off for at least 2 weeks prior to procedure, off during 3-month follow up window
• PTNS - no treatments within 2 weeks of start, none during 3-month post-procedure follow up window
• OAB meds - 2 week wash out period prior to injection, none during 3-month post-procedure follow up window
• Currently pregnant or trying to get pregnant
• Contraindications to Botox® - hypersensitivity to Botox®, inability to self-catheterize/refusal to have indwelling catheter
• Have a UTI (can enroll after treatment)
• Have urinary retention (PVR\>150cc on two occasions)
• Do not speak English or Spanish

Sponsors & Collaborators

• University of California, Irvine: lead
• Kaiser Permanente: collaborator
• St. Joseph Hospital of Orange: collaborator

Study Sites (1)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (10)

• Brubaker L, Richter HE, Visco A, Mahajan S, Nygaard I, Braun TM, Barber MD, Menefee S, Schaffer J, Weber AM, Wei J; Pelvic Floor Disorders Network. Refractory idiopathic urge urinary incontinence and botulinum A injection. J Urol. 2008 Jul;180(1):217-22. doi: 10.1016/j.juro.2008.03.028. Epub 2008 May 21.

  PMID: 18499184 BACKGROUND

• Chapple C, Sievert KD, MacDiarmid S, Khullar V, Radziszewski P, Nardo C, Thompson C, Zhou J, Haag-Molkenteller C. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2013 Aug;64(2):249-56. doi: 10.1016/j.eururo.2013.04.001. Epub 2013 Apr 10.

  PMID: 23608668 BACKGROUND

• Visco AG, Brubaker L, Richter HE, Nygaard I, Paraiso MF, Menefee SA, Schaffer J, Lowder J, Khandwala S, Sirls L, Spino C, Nolen TL, Wallace D, Meikle SF; Pelvic Floor Disorders Network. Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence. N Engl J Med. 2012 Nov 8;367(19):1803-13. doi: 10.1056/NEJMoa1208872. Epub 2012 Oct 4.

  PMID: 23036134 BACKGROUND

• Amundsen CL, Richter HE, Menefee SA, Komesu YM, Arya LA, Gregory WT, Myers DL, Zyczynski HM, Vasavada S, Nolen TL, Wallace D, Meikle SF. OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. JAMA. 2016 Oct 4;316(13):1366-1374. doi: 10.1001/jama.2016.14617.

  PMID: 27701661 BACKGROUND

• Nitti VW, Dmochowski R, Herschorn S, Sand P, Thompson C, Nardo C, Yan X, Haag-Molkenteller C; EMBARK Study Group. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol. 2013 Jun;189(6):2186-93. doi: 10.1016/j.juro.2012.12.022. Epub 2012 Dec 14.

  PMID: 23246476 BACKGROUND

• Liao CH, Chen SF, Kuo HC. Different number of intravesical onabotulinumtoxinA injections for patients with refractory detrusor overactivity do not affect treatment outcome: A prospective randomized comparative study. Neurourol Urodyn. 2016 Aug;35(6):717-23. doi: 10.1002/nau.22780. Epub 2015 Apr 24.

  PMID: 25914349 BACKGROUND

• Coelho A, Cruz F, Cruz CD, Avelino A. Spread of onabotulinumtoxinA after bladder injection. Experimental study using the distribution of cleaved SNAP-25 as the marker of the toxin action. Eur Urol. 2012 Jun;61(6):1178-84. doi: 10.1016/j.eururo.2012.01.046. Epub 2012 Feb 1.

  PMID: 22306320 BACKGROUND

• Mehnert U, Boy S, Schmid M, Reitz A, von Hessling A, Hodler J, Schurch B. A morphological evaluation of botulinum neurotoxin A injections into the detrusor muscle using magnetic resonance imaging. World J Urol. 2009 Jun;27(3):397-403. doi: 10.1007/s00345-008-0362-0. Epub 2009 Jan 15.

  PMID: 19145439 BACKGROUND

• Ton J, Downing P, Versi E, van Uem S, Ephraim S, Murphy M, Lucente V. Outcomes of a single trigone-only vs. 20 trigone-sparing injections of OnabotulinumtoxinA for refractory overactive bladder (OAB). Int Urol Nephrol. 2021 Jun;53(6):1067-1072. doi: 10.1007/s11255-021-02802-0. Epub 2021 Mar 19.

  PMID: 33742316 BACKGROUND

• Avallone MA, Sack BS, El-Arabi A, Guralnick ML, O'Connor RC. Less is more-A pilot study evaluating one to three intradetrusor sites for injection of OnabotulinumtoxinA for neurogenic and idiopathic detrusor overactivity. Neurourol Urodyn. 2017 Apr;36(4):1104-1107. doi: 10.1002/nau.23052. Epub 2016 Jun 10.

  PMID: 27283922 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

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; Urinary Incontinence; 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: Dr. Carly Crowder
• Organization: UC Irvine Medical Center

crowderc@hs.uci.edu

7144562911

Study Officials

• Carly Crowder, MD

  UC Irvine

  PRINCIPAL INVESTIGATOR

• Taylor Brueseke, MD

  UC Irvine

  STUDY DIRECTOR

• Felicia Lane, MD

  UC Irvine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• 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: Fellow Physician, PI

Model Details: Parallel study with 2 arms, 1:1 randomization

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 4, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: February 25, 2026
• Results First Posted: February 14, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)