Transvaginal Botulinum Toxin A for Interstitial Cystitis / Bladder Pain Syndrome

NCT05485207 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: IRB-58532
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Interstitial cystitis / bladder pain syndrome (IC/BPS) is a debilitating condition that affects millions of women in the United States. Women suffer from recurring pelvic pain, bladder pressure, painful bladder, urinary frequency (needing to go often) and urgency (feeling a strong need to go). Women are five times more likely to suffer from IC/BPS than men. IC/BPS is a common cause of painful bladder after excluding urinary tract infection. About one-third of women resort to opioids, thus contributing to the current opioid crisis. Sadly, there are no durable treatments and the majority of therapies are not FDA-approved for IC/BPS.

Conditions

Interstitial Cystitis; Bladder Pain Syndrome

Keywords

IC/BPS

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Patient Global Impression of Change (PGIC) scale

  Patients will be classified as treatment success if they achieve our primary efficacy outcome of a \>50% improvement in the Patient Global Impression of Change (PGIC) scale

  Baseline through week 12

Secondary Outcomes (4)

• Change from baseline in American Urological Association Symptom Score (AUASS)

  Baseline through week 12

• Change from baseline in International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ FLUTS)

  Baseline through week 12

• Change from baseline in Short Form 12-item Survey (SF12)

  Baseline through week 12

• Change from baseline in O'Leary Sant (OLS) Symptom Score [Interstitial Cystitis Symptom Index (ICSI) / Interstitial Cystitis Problem Index (ICPI)]

  Baseline through week 12

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 IC/BPS
• Females who are considering intradetrusor BTA chemodenervation for the treatment of refractory IC/BPS

You may not qualify if:

• Involvement in other studies with potentially overlapping indications or symptoms
• Patients who are unable to undergo a transvaginal intervention as a result of anatomic barriers or discomfort will be excluded from enrollment
• patients known to be pregnant or breastfeeding
• Known allergy to BTA injection therapy or lidocaine

Sponsors & Collaborators

• Stanford University: lead
• McCormick and Gabilan Faculty Fellowship Award: collaborator

Study Sites (1)

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

Palo Alto, California, 94304, United States

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Injections

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

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: Assistant Professor of Urology

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: April 4, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)