Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain

Completed · Not applicable

Conditions studied: Pelvic Pain

In brief

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).

Key facts

Study ID

NCT02369068

Run by

Jamie Bartley, DO

People needed

21

Starts

2015-08-01

Expected to finish

2018-09-24

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Beaumont Hospitals — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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