| NCT ID | NCT06796985 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Miami |
| Condition | Pelvic Floor Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02-24 |
| Primary Completion | 2027-03-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-02-24 with a primary completion date of 2027-03-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Females between 18 and 75 years of age 2. Clinical diagnosis of chronic pelvic pain 3. 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) \* 4. Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers 5. Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination 6. No botulinum neurotoxin pelvic floor muscle injection treatment within 6 months prior to recruitment 7. Able to provide informed consent Exclusion Criteria: 1. Males 2. Women \< 18 and \> 76 years of age 3. History of pelvic malignancy and sexual transmitted diseases that is currently not in remission 4. Bleeding disorder such as coagulopathy 5. Hypersensitivity to botulinum neurotoxin 6. Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior to recruitment 7. History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis 8. Pregnancy, breast feeding or planning to get pregnant within one year after the last botulinum neurotoxin injection.
Contact & Investigator
Yingchun Zhang, PhD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT06796985 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Pelvic Floor Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06796985 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06796985 currently recruiting?
Yes, NCT06796985 is actively recruiting participants. Contact the research team at y.zhang@miami.edu for enrollment information.
Where is the NCT06796985 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT06796985 clinical trial?
NCT06796985 is sponsored by University of Miami. The principal investigator is Yingchun Zhang, PhD at University of Miami. The trial plans to enroll 30 participants.