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New treatment option for Pelvic Floor Disorders
Official title Botox for Chronic Pelvic Pain
ClinicalTrials.gov ID: NCT06796985
What this study is testing
What is Botulinum neurotoxin?
Botulinum neurotoxin is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for pelvic floor disorders.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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...
- 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
You likely can't join if
- Males
- Women \ 76 years of age
- History of pelvic malignancy and sexual transmitted diseases that is currently not in remission
- Bleeding disorder such as coagulopathy
- Hypersensitivity to botulinum neurotoxin
- Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior to recruitment
See the full eligibility 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...
- 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
- Able to provide informed consent
- Males
- Women \ 76 years of age
- History of pelvic malignancy and sexual transmitted diseases that is currently not in remission
- Bleeding disorder such as coagulopathy
- Hypersensitivity to botulinum neurotoxin
- Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior to recruitment
- History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis
- Pregnancy, breast feeding or planning to get pregnant within one year after the last botulinum neurotoxin injection.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.