Intravesicular Onabotulinumtoxin A in Interstitial Cystitis

Interstitial Cystitis Clinical Trial

Official title:

The Impact of Injection Location on the Efficacy of Intravesicular Onabotulinumtoxin A in Interstitial Cystitis--Phase 4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297100
• Other study ID #: IRB00026734
• Status: Completed
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: January 10, 2018

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Drug:
• Onabotulinumtoxin A
100 units of botox spread out among 10 separate injections

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.
• 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.

Locations

Country	Name	City	State
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Secondary Outcomes Will be Assessing Change in Patient Performance in Post Void Residuals.		30 days and 90 days post treatment
Primary	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
Primary	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	Change in Patient Performance in Uroflowmetry.	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.	30 days and 90 days post treatment