Injection With OnabotulinumtoxinA (Botox) for the Treatment of Chronic Pelvic Pain (NCT02173405) | Clinical Trial Compass
CompletedPhase 1
Injection With OnabotulinumtoxinA (Botox) for the Treatment of Chronic Pelvic Pain
United States10 participantsStarted 2014-08-01
Plain-language summary
This research study because is looking at woman with symptoms of chronic pelvic pain caused by short, tight, and tender pelvic floor muscles (Myofascial Pelvic Pain syndrome). The purpose of this study is to determine whether or not injections with onabotulinumtoxinA (Botox) improve symptoms of pain and tenderness. The drug being studied, Botox is FDA approved for other uses. However, Botox is not FDA approved for the use in myofascial pelvic pain (MPP). Therefore, Botox is considered experimental or research in this study.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Females age 18 years to 65 years
. MPP for at least 6 months with pain ranked \> 7/10 by VAS
. Able to make medical decisions for herself
. Ability to speak and understand English
. Ability to follow study instructions and likely to complete all required visits 6 .Must give written informed consent before enrolment in this study
Exclusion criteria
. Pelvic onabotulinumA injections within the last 6 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
efficacy
Timeframe: at 1 month post treatment versus placebo
Trial details
NCT IDNCT02173405
SponsorUniversity Hospitals Cleveland Medical Center
. Pelvic floor physical therapy (PFPT) within the last 1 months
. Pelvic surgery within the last 1 year
. PVR greater than 150 ml
. Presence of interstitial cystitis/ painful bladder syndrome (IC/PBS) by the current The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) criteria 37.
. Evidence of pelvic pathology or other active diagnoses of acute or chronic pain syndromes including endometriosis, chronic cystitis, acute urinary tract infection, vaginitis, pelvic inflammatory disease, etc.
. Breastfeeding, pregnant or contemplating pregnancy in the next 1 year or not on a current reliable form of birth control
. Patients with known neurological diseases involving impaired neurotransmission, including myasthenia gravis and Charcot-Marie-Tooth disease