Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2019 |
| Start Date: | August 2015 |
| End Date: | September 24, 2018 |
A Double-Blind, Randomized Study to Compare Onabotulinumtoxin A Versus Kenalog for Intravaginal Trigger Point Injections in the Treatment of Chronic Pelvic Pain
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).
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).
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
