Clinical trial NCT02297100: Intravesicular Onabotulinumtoxin A in Interstitial Cystitis
Official title: The Impact of Injection Location on the Efficacy of Intravesicular Onabotulinumtoxin A in Interstitial Cystitis--Phase 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Interstitial Cystitis
Keywords: women
interstitial cystitis
bladder pain syndrome
botox
onabotulinum toxin A
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2014-11-21
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes.
timeFrame: 30 and 90 days post treatment
measure: The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire
timeFrame: 30 and 90 days post-treatment
Secondary outcomes:
measure: Change in Patient Performance in Uroflowmetry.
timeFrame: 30 days and 90 days post treatment
Other outcomes:
measure: Secondary Outcomes Will be Assessing Change in Patient Performance in Post Void Residuals.
timeFrame: 30 days and 90 days post treatment
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Robert J Evans, M.D.
role: PRINCIPAL_INVESTIGATOR
References: