Botox for Chronic Pelvic Pain (NCT06796985) | Clinical Trial Compass
RecruitingPhase 1
Botox for Chronic Pelvic Pain
United States30 participantsStarted 2025-02-24
Plain-language summary
The purpose of this research study is to find out if precise, targeted injection of botulinum neurotoxin (commonly known as Botox) provides better relief of pelvic floor hypertonicity and pain than the standard method being used. The researchers want to better understand the effects (good and bad) of targeted botulinum neurotoxin injections in women with pelvic floor disorders.
Who can participate
Age range
18 Years – 75 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 between 18 and 75 years of age
. Clinical diagnosis of chronic pelvic pain
. Complaints of pain, pressure, or discomfort in the bladder and/or pelvic area for the past 6 months or more, associated with lower urinary tract symptoms (such as frequency of urination), in the absence of other explanation of the symptoms (e.g., UTI) \*
. Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers
. Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination
. No botulinum neurotoxin pelvic floor muscle injection treatment within 6 months prior to recruitment
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.
1Since this is a Phase 1 trial focused on measuring muscle activity with a specialized EMG sensor rather than proving the treatment works, what does that mean for how much is already known about safety and benefit from Botox for my specific pelvic floor condition?
2The trial is measuring something called a 'hypertonic index' using high-density surface EMG — can you explain what that test involves physically, how often I'd need to do it, and whether it would be uncomfortable or invasive for me?
3Given that this is an early-phase study still actively recruiting, would it make sense for me to try any established standard treatments for pelvic floor disorders first, or is there a reason you might recommend considering this trial at this stage of my care?
4How would receiving Botox injections into my pelvic muscles in a research setting differ from any existing clinical uses of Botox for pelvic floor problems, and what monitoring would be in place if I experienced side effects?
5What are the practical time commitments involved — like how many visits, how far apart, and what happens to my regular treatment plan while I'm participating — and how would that fit with my current situation?'
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
Hypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG)