Pelvic Floor Disorders study: Botulinum neurotoxin
Official title Botox for Chronic Pelvic Pain
ClinicalTrials.gov ID: NCT06796985
What this study is testing
What is Botulinum neurotoxin?
An investigational injectable medicine being studied for relief of pelvic floor hypertonicity and pain in women with pelvic floor disorders.
Also referred to as Botox.
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 study aims to see if precise Botox injections relieve pelvic floor hypertonicity and pain better than the usual method. It also looks at the benefits and possible side effects of this approach.
- Who it's for
- Women who have pelvic floor disorders and chronic pelvic pain.
- What's involved
- Participants will receive Botox injections into the pelvic floor muscles. They will have follow‑up visits and tests to monitor pain and muscle tone.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.