Intravesicular Onabotulinumtoxin A in Interstitial Cystitis

NCT ID: NCT02297100

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2018-01-10

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.

Detailed Description

The purpose of this study is to evaluate the efficacy of intravesicular Onabotulinumtoxin A injections for the treatment of interstitial cystitis (IC). Specifically, we hypothesize that trigonal Onabotulinumtoxin A injections is an effective treatment for IC and will result in more subjective and objective symptom relief than posterior wall Onabotulinumtoxin A injections.

Conditions

Interstitial Cystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Botox upper aspect trigone

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.

Group Type: EXPERIMENTAL

Onabotulinumtoxin A

Intervention Type: DRUG

100 units of botox spread out among 10 separate injections

injections upper aspect of trigone of urinary bladder

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

Onabotulinumtoxin A

Intervention Type: DRUG

100 units of botox spread out among 10 separate injections

injections on posterior bladder wall excluding the trigone

Intervention Type: PROCEDURE

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

Interventions

Onabotulinumtoxin A

100 units of botox spread out among 10 separate injections

Intervention Type: DRUG

injections upper aspect of trigone of urinary bladder

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

Intervention Type: PROCEDURE

injections on posterior bladder wall excluding the trigone

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

Intervention Type: PROCEDURE

Other Intervention Names

Botox

Eligibility Criteria

Inclusion Criteria

1. Adult females between the ages of 18 and 80 inclusive

2. Patients being treated for IC who are refractory to conservative management and oral therapy.

3. willing and able to initiate catheterization post-treatment

Exclusion Criteria

1. 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.

2. Currently on or requiring anti-platelet/anti-coagulant concomitant therapy or having been on anti-platelet/ anti-coagulant therapy within the past 3 months

3. 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.

4. 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.

5. A history of hypersensitivity or allergy to any botulinum toxin preparation

6. A post-void residual (PVR) urine volume >200mL at baseline

7. Treatment with botulinum toxin during the 12 week period prior to the trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert J Evans, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00026734

Identifier Type: -

Identifier Source: org_study_id