NCT02369068

Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain

A Double-Blind, Randomized Study to Compare Onabotulinumtoxin A Versus Kenalog for Intravaginal Trigger Point Injections in the Treatment of Chronic Pelvic Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Jamie Bartley, DO · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Chronic pelvic pain (CPP) is a common and often debilitating problem among women. The musculoskeletal system is an important factor in chronic pelvic pain. Studies have demonstrated that women with CPP had more frequent musculoskeletal findings. On physical examination, myofascial trigger points have been found. Trigger points are hyperirritable bands of muscle that can be felt from the vaginal wall. They are often knot-like or taut and are painful when pressure is placed on them. Intravaginal injections of these trigger points using steroids including Kenalog (triamcinolone) have been done and produced decreases in pelvic pain. Trigger point injections of Onabotulinumtoxin A has also been shown to decrease pain in subjects with CPP. This study will compare these two drugs and assess pain (using subject questionnaires) at one, three and six months post injection.

Conditions

• Pelvic Pain

Interventions

Type	Name	Description
DRUG	Onabotulinumtoxin A	Intravaginal pelvic floor injection one series
DRUG	Kenalog	Intravaginal pelvic floor injection one series

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-03-26
• Completion: 2018-09-24
• First posted: 2015-02-23
• Last updated: 2019-07-24
• Results posted: 2019-02-06

Locations

1 site across 1 country: United States