Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 158 for:    interstitial cystitis

Intravesicular Onabotulinumtoxin A in Interstitial Cystitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
Collaborator:
Allergan
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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.




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297100


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Robert J Evans, M.D. Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02297100     History of Changes
Other Study ID Numbers: IRB00026734
First Posted: November 21, 2014    Key Record Dates
Results First Posted: May 22, 2018
Last Update Posted: September 5, 2018
Last Verified: August 2018

Layout table for additional information
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:
Layout table for 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