Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain
CompletedNot applicableNCT02369068
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The goal of this study is to compare the effectiveness of two different medications used in intravaginal trigger point injections (injections into extremely painful areas of a muscle) to treat chronic pelvic pain. The study compares onabotulinumtoxinA (BOTOX®) (a drug prepared from the bacterial toxin botulin which temporarily paralyzes muscles) to Kenalog (a synthetic corticosteroid used as an anti-inflammatory agent).
Study details
- Official title
- A Double-Blind, Randomized Study to Compare Onabotulinumtoxin A Versus Kenalog for Intravaginal Trigger Point Injections in the Treatment of Chronic Pelvic Pain
- Conditions
- Interventions
- Drug: Onabotulinumtoxin A
- Drug: Kenalog
- Sponsor
- Jamie Bartley, DO
- Organization
- Corewell Health East
- Start date
- 2015-08
- Primary completion
- 2018-03-26
- Sex
- Female
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Provide informed consent * Healthy women \> age 18 regardless of menopausal status * Willing and able to fill out study questionnaires. In patients that are unable to read, the research nurse will be available to assist. * High-tone pelvic floor dysfunction on vaginal exam * A pelvic pain score of \> 4 on screening Visual Analog Scale (VAS) * Pain perceived to be in the pelvis that has been present for at least 3 months. Exclusion Criteria: * Patients that have had Botox to the bladder within the last 8 months * Patients that have had Botox outside the bladder of \> 160 u within the last 12 weeks. * Patients that have had transvaginal trigger point injections of any form (Botox or steroid) in the last 3 months * Pregnancy * Concomitant use of any narcotic drug, alcohol, or any illicit drug use during the study period that could be deemed unsafe in combination with study medication as judged by the investigators. * Any evidence of vaginitis on wet mount slide at initial visit that is untreated. * Subject with any other vaginal epithelial disorder that could affect absorption of medication as deemed by the investigators. * Any indication/condition/medication that the investigators identify as contraindicated in conjunction with study medication. * Systolic blood pressure \> 160 mm Hg on screening blood pressure * Heart rate \> 110 beats/minute on screening heart rate
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02369068