Intravesicular Onabotulinumtoxin A in Interstitial Cystitis

NCT02297100 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00026734
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to identify the optimal usage of Onabotulinumtoxin A in interstitial cystitis. Onabotulinumtoxin A, more commonly known by the trade name Botox®, is a medication that comes from the bacteria Clostridium botulinum. It works by blocking the release of the neurotransmitter acetylcholine(a chemical messenger that carries signals between nerve cells and other cells in the body). Blocking that neurotransmitter results in decreased muscle activity.

Conditions

Interstitial Cystitis

Keywords

women; interstitial cystitis; bladder pain syndrome; botox; onabotulinum toxin A

Outcome Measures

Primary Outcomes (2)

• The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes.

  The O'Leary-Sant is one questionnaire that assesses the severity of symptoms and the how much of a problem the symptoms cause for the patient and it provides two scores. The scores ranges for the symptoms is 0-20 and for how bothersome the symptoms are, the score range is 0-16. Higher scores for both denotes worse outcomes.

  30 and 90 days post treatment

• The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire

  The PUF questionnaire evaluates symptoms of pain and how much they bother the patient. Two score are given and added together to produce a total score. The score range for symptoms is 0-28 and the range for bother is 0-16. Higher scores denotes worse outcomes.

  30 and 90 days post-treatment

Secondary Outcomes (1)

• Change in Patient Performance in Uroflowmetry.

  30 days and 90 days post treatment

Other Outcomes (1)

• Secondary Outcomes Will be Assessing Change in Patient Performance in Post Void Residuals.

  30 days and 90 days post treatment

Study Arms (2)

Botox upper aspect trigone

EXPERIMENTAL

Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.

Drug: Onabotulinumtoxin A; Procedure: injections upper aspect of trigone of urinary bladder

botox periphery of trigone

ACTIVE COMPARATOR

Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).

Drug: Onabotulinumtoxin A; Procedure: injections on posterior bladder wall excluding the trigone

Interventions

Onabotulinumtoxin A DRUG

100 units of botox spread out among 10 separate injections

Also known as: Botox

Botox upper aspect trigone; botox periphery of trigone

injections upper aspect of trigone of urinary bladder PROCEDURE

We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.

Botox upper aspect trigone

injections on posterior bladder wall excluding the trigone PROCEDURE

We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.

botox periphery of trigone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult females between the ages of 18 and 80 inclusive
• Patients being treated for IC who are refractory to conservative management and oral therapy.
• willing and able to initiate catheterization post-treatment

You may not qualify if:

• Any history of bladder cancer, uterine cancer, ovarian cancer, vaginal cancer, urethral diverticulum, spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida, cyclophosphamide treatment, radiation treatment to the pelvis, bladder tuberculosis, genital herpes.
• Currently on or requiring anti-platelet/anti-coagulant concomitant therapy or having been on anti-platelet/ anti-coagulant therapy within the past 3 months
• Pregnancy. Pregnancy is an absolute contraindication to undergoing these procedures. Thus, as part of their normal pre-operative work up, which is standard of care, pregnancy tests are administered if they are women of child-bearing age, are sexually active, and are within 10 days of the normal menstrual period. If positive, they will be excluded as they will not undergo the procedure.
• An active urinary tract infection as shown during clean-catch urinalysis at screening visit. Subject may be re-screened if UTI is successfully treated and urinalysis is negative at rescreening.
• A history of hypersensitivity or allergy to any botulinum toxin preparation
• A post-void residual (PVR) urine volume \>200mL at baseline
• Treatment with botulinum toxin during the 12 week period prior to the trial

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Allergan: collaborator

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

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

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. Robert Evans
• Organization: Wake Forest University Health Sciences

revans@wakehealth.edu

336-713-0320

Study Officials

• Robert J Evans, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: November 21, 2014
• Study Start: December 1, 2014
• Primary Completion: January 10, 2018
• Study Completion: January 10, 2018
• Last Updated: September 5, 2018
• Results First Posted: May 22, 2018

Record last verified: 2018-08

Locations

US (1)