Intravesicular Onabotulinumtoxin A in Interstitial Cystitis

• ClinicalTrials.gov Identifier: NCT02297100
• Recruitment Status: Completed
• First Posted: November 21, 2014
• Results First Posted: May 22, 2018
• Last Update Posted: September 5, 2018
• Sponsor: Wake Forest University Health Sciences
• Collaborator: Allergan
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Interstitial Cystitis	Drug: Onabotulinumtoxin A; Procedure: injections upper aspect of trigone of urinary bladder; Procedure: injections on posterior bladder wall excluding the trigone	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Impact of Injection Location on the Efficacy of Intravesicular Onabotulinumtoxin A in Interstitial Cystitis--Phase 4
• Actual Study Start Date: December 2014
• Actual Primary Completion Date: January 10, 2018
• Actual Study Completion Date: January 10, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Onabotulinumtoxin A; 100 units of botox spread out among 10 separate injections; Other Name: Botox; Procedure: 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.
Active Comparator: 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).	Drug: Onabotulinumtoxin A; 100 units of botox spread out among 10 separate injections; Other Name: Botox; 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.

Outcome Measures

Primary Outcome Measures :

1. The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes. [ Time Frame: 30 and 90 days post treatment ]
   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.
2. The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire [ Time Frame: 30 and 90 days post-treatment ]
   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.

Secondary Outcome Measures :

1. Change in Patient Performance in Uroflowmetry. [ Time Frame: 30 days and 90 days post treatment ]
   Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.

Other Outcome Measures:

1. Secondary Outcomes Will be Assessing Change in Patient Performance in Post Void Residuals. [ Time Frame: 30 days and 90 days post treatment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, North Carolina

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States, 27103

Sponsors and Collaborators

Wake Forest University Health Sciences

Allergan

Investigators

• Principal Investigator: Robert J Evans, M.D.; Wake Forest University Health Sciences

  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

Study Protocol and Statistical Analysis Plan  [PDF] August 15, 2014

More Information

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02297100
• Other Study ID Numbers: IRB00026734
• First Posted: November 21, 2014
• Results First Posted: May 22, 2018
• Last Update Posted: September 5, 2018
• Last Verified: August 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:

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

Additional relevant MeSH terms:

Cystitis; Cystitis, Interstitial; Urinary Bladder Diseases; Urologic Diseases; Botulinum Toxins, Type A; abobotulinumtoxinA; Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents