Transvaginal Botulinum Toxin A Chemodenervation for Overactive Bladder

NCT05463822 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: IRB-44813SPO # 133508
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Overactive bladder (OAB) is a highly prevalent disease process that, when refractory to oral medication therapy, can be effectively managed with injection of botulinum toxin A (BTA) into the detrusor muscle of the bladder. However, the traditional procedure requires a cystoscope inserted into the bladder which can be painful and is associated with a risk of urinary tract infection. The purpose of this study is to determine if transvaginal injection of BTA into the detrusor muscle of the bladder wall is feasible to perform, and efficacious for the treatment of refractory overactive bladder.

Conditions

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

Keywords

overactive bladder; bladder chemodenervation

Outcome Measures

Primary Outcomes (1)

• Response to the Treatment Benefit Scale (TBS) Questionnaire

  Assessing improvement in urinary symptoms following intervention. The Treatment Benefit Scale Questionnaire asks patients to state if their condition (overactive bladder) has 1) greatly improved, 2) improved, 3) not changed, or 4) worsened during treatment. Patients who select 1 or 2 are considered to have derived a perceived benefit from the treatment, and will represent those patients who had a positive TBS response.

  at 6 weeks and 12 weeks following baseline injection visit (week 0)

Secondary Outcomes (4)

• Change in Voiding Diary Symptoms - number of mean daily urgency episodes

  baseline injection visit (week 0) and then at 6 weeks and 12 weeks following intervention

• Change in Voiding Diary Symptoms - number of mean daily micturition episodes

  baseline injection visit (week 0) and then at 6 weeks and 12 weeks following intervention

• Change in Overactive Bladder questionnaire, Short Form

  baseline injection visit (week 0) and then at 6 weeks and 12 weeks following intervention

• Change in International Consultation on Incontinence Questionnaire - short form

  baseline injection visit (week 0) and then at 6 weeks and 12 weeks following intervention

Other Outcomes (2)

• Assessment of post void residual

  baseline injection visit (week 0) and then at 6 weeks and 12 weeks following intervention

• Tolerability of the Procedure using the Procedural Pain Questionnaire

  at time of intervention (week 0)

Study Arms (1)

Transvaginal botulinum toxin A (BTA) injection

EXPERIMENTAL

Botulinum toxin A (Botox® 100 units) will be injected into the detrusor muscle of the bladder by inserting a needle through the anterior vaginal wall.

Drug: Transvaginal botulinum toxin A (BTA) injection

Interventions

Transvaginal botulinum toxin A (BTA) injection DRUG

Botulinum toxin A (Botox® 100 units) will be injected into the detrusor muscle of the bladder by inserting a needle through the anterior vaginal wall.

Also known as: Botox® 100 units

Transvaginal botulinum toxin A (BTA) injection

Eligibility Criteria

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

You may qualify if:

• Females with overactive bladder
• Females who are considering intradetrusor botulinum toxin A chemodenervation for the treatment of refractory overactive bladder

You may not qualify if:

• Overactive bladder caused by neurological condition (i.e. spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, etc.)
• Predominance of stress urinary incontinence as reported by the patient
• Involvement in other studies with potentially overlapping indications or symptoms
• Patients who are unable to undergo a transvaginal ultrasound intervention as a result of anatomic barriers or discomfort will be excluded from enrollment
• Patients known to be pregnant or breastfeeding
• Known allergy to botulinum toxin A injection therapy

Sponsors & Collaborators

• Stanford University: lead
• Society for Urodynamics & Female Urology Foundation: collaborator

Study Sites (1)

Urology Clinic (Stanford University), 1000 Welch Road, Suite 100

Stanford, California, 94304, United States

Location

Related Publications (9)

• Sun Y, Luo D, Tang C, Yang L, Shen H. The safety and efficiency of onabotulinumtoxinA for the treatment of overactive bladder: a systematic review and meta-analysis. Int Urol Nephrol. 2015 Nov;47(11):1779-88. doi: 10.1007/s11255-015-1125-7. Epub 2015 Oct 3.

  PMID: 26433883 BACKGROUND

• Gormley EA, Lightner DJ, Burgio KL, Chai TC, Clemens JQ, Culkin DJ, Das AK, Foster HE Jr, Scarpero HM, Tessier CD, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol. 2012 Dec;188(6 Suppl):2455-63. doi: 10.1016/j.juro.2012.09.079. Epub 2012 Oct 24.

  PMID: 23098785 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

• Abdel-Meguid TA. Botulinum toxin-A injections into neurogenic overactive bladder--to include or exclude the trigone? A prospective, randomized, controlled trial. J Urol. 2010 Dec;184(6):2423-8. doi: 10.1016/j.juro.2010.08.028. Epub 2010 Oct 16.

  PMID: 20952003 BACKGROUND

• Kuo HC. Bladder base/trigone injection is safe and as effective as bladder body injection of onabotulinumtoxinA for idiopathic detrusor overactivity refractory to antimuscarinics. Neurourol Urodyn. 2011 Sep;30(7):1242-8. doi: 10.1002/nau.21054. Epub 2011 May 10.

  PMID: 21560152 BACKGROUND

• Lucioni A, Rapp DE, Gong EM, Fedunok P, Bales GT. Intravesical botulinum type A toxin injection in patients with overactive bladder: Trigone versus trigone-sparing injection. Can J Urol. 2006 Oct;13(5):3291-5.

  PMID: 17076955 BACKGROUND

• Syan R, Briggs MA, Olivas JC, Srivastava S, Comiter CV, Dobberfuhl AD. Transvaginal ultrasound guided trigone and bladder injection: A cadaveric feasibility study for a novel route of intradetrusor chemodenervation. Investig Clin Urol. 2019 Jan;60(1):40-45. doi: 10.4111/icu.2019.60.1.40. Epub 2018 Dec 24.

  PMID: 30637360 BACKGROUND

• Dobberfuhl AD, van Uem S, Versi E. Trigone as a diagnostic and therapeutic target for bladder-centric interstitial cystitis/bladder pain syndrome. Int Urogynecol J. 2021 Dec;32(12):3105-3111. doi: 10.1007/s00192-021-04878-9. Epub 2021 Jun 22.

  PMID: 34156506 RESULT

• Dobberfuhl AD. Pathophysiology, assessment, and treatment of overactive bladder symptoms in patients with interstitial cystitis/bladder pain syndrome. Neurourol Urodyn. 2022 Nov;41(8):1958-1966. doi: 10.1002/nau.24958. Epub 2022 May 24.

  PMID: 35607890 RESULT

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

Injections

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)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Amy D. Dobberfuhl, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: July 19, 2022
• Study Start: June 20, 2019
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)