Comparative Study Suburothelial and Trigonal Botulinum Toxin A Injection in Treatment of Interstitial Cystitis

NCT03076762 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: BuddhistTCGH2003-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There is no consensus of the therapeutic efficacy and safety between suburothelial injection and trigonal injection of botulinum toxin A (BoNT-A) in treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) It is unmet to clarify which injection method is superior in clinical efficacy and patient safety. This study was designed in a randomized, double-blind trial to test the therapeutic effects and adverse events between intravesical BoNTA injection into suburothelium and trigone. The results of this study might provide clinical evidence for a better therapeutic regimen of BoNT-A in the treatment of IC/PBS.

Conditions

Bladder Pain Syndrome

Keywords

interstitial cystitis; pain; intravesical injection; therapy; bladder

Outcome Measures

Primary Outcomes (1)

• Reduction of bladder pain visual analog scale (VAS)

  Evaluation of the change of VAS from baseline to 8 weeks

  baseline to 8 weeks

Secondary Outcomes (6)

• Interstitial cystitis symptom index (ICSI)

  baseline to 8 weeks

• Functional bladder capacity

  baseline to 8 weeks

• Maximum flow rate (Qmax)

  baseline to 8 weeks

• Voided volume

  baseline to 8 weeks

• Postvoid residual volume

  baseline to 8 weeks

Study Arms (2)

Intravesical suburothelial injection

EXPERIMENTAL

Patients assigned for suburothelial injections received 100 U of onabotulinumtoxinA in 20 sites injected in the bladder body on treatment day and follow-up

Drug: intravesical onabotulinumtoxinA injection

Intravesical trigonal injection

ACTIVE COMPARATOR

Patients assigned trigonal injections will receive 100U of onabotulinumtoxinA at 10 sites injected at the trigonal area (5 injections behind interureteric ridge and 5 inside the trigone) on treatment day and follow-up.

Drug: intravesical onabotulinumtoxinA injection

Interventions

intravesical onabotulinumtoxinA injection DRUG

Each vial of onabotulinumtoxinA will be diluted with 10 ml of normal saline, resulting in 10U onabotulinumtoxinA per 1.0 ml. Patients assigned for suburothelial BoNT-A injections received 20 injections in the bladder body whereas those assigned trigonal injections will receive 10 sites injections at the trigonal area (5 injections behind interureteric ridge and 5 inside the trigone).

Also known as: BOTOX

Intravesical suburothelial injection; Intravesical trigonal injection

Eligibility Criteria

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

You may qualify if:

• Patients have been diagnosed as IC/BPS based on characteristic symptoms and cystoscopic findings of glomerulations, petechia, or mucosal fissures after hydrodistention
• Patients have been treated with at least two types of treatment modalities including non-steroid anti-inflammatory drugs, oral PPS, intravesical instillation of heparin, hyaluronic acid, or tricyclic antidepressant for at least 6 months but the symptoms remained unchanged or relapsed.
• Patients who have bladder pain VAS of 3 or greater

You may not qualify if:

• Patients with Hunner's ulcer
• Patients with active urinary tract infection
• Patients who cannot keep a 3-day voiding diary prior to treatment
• Patients who do not sign informed consent form

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, 970, Taiwan

RECRUITING

Related Publications (1)

• Jiang YH, Jhang JF, Lee CL, Kuo HC. Comparative study of efficacy and safety between bladder body and trigonal intravesical onabotulinumtoxina injection in the treatment of interstitial cystitis refractory to conventional treatment-A prospective, randomized, clinical trial. Neurourol Urodyn. 2018 Apr;37(4):1467-1473. doi: 10.1002/nau.23475. Epub 2018 Jan 13.

  PMID: 29331031 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial; Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

Study Officials

• Hann-Chorng HC Kuo, M.D.

  Department of Urology, Buddhist Tzu Chi General Hospital, Hualien

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hann-Chorng HC Kuo, M.D.

CONTACT

886-3-8561825; hck@tzuchi.com.tw

Dong-Ling DL Tang, Miss

CONTACT

886-3-8561825; hck@tzuchi.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigator and outcome assessor are blinded to the treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Urology

Model Details: Eligible patients will be randomly assigned to receive intravesical injection of 100U of BoNT-A (BOTOX, Allergan, Irvine, CA, USA) into the trigone (the treatment group) or suburothelium (the comparative group) immediately followed by cystoscopic hydrodistention under intravenous general anesthesia in the operation room.

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 10, 2017
• Study Start: March 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)