Actively Recruiting
Botox for Chronic Pelvic Pain
Led by University of Miami · Updated on 2025-07-29
30
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Botox for Chronic Pelvic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Females between 18 and 75 years of age
- Clinical diagnosis of chronic pelvic pain
- Pain, pressure, or discomfort in the bladder and/or pelvic area for 6 months or more, with urinary symptoms and no other explanation
- Myofascial pain with palpable contracted muscle bands or nodules
- Pelvic muscle tenderness confirmed by digital pelvic examination
- No botulinum neurotoxin injection in pelvic floor muscles within 6 months before joining
- Able to provide informed consent
You will not qualify if you...
- Males
- Women younger than 18 or older than 75 years
- History of pelvic cancer or sexually transmitted diseases currently not in remission
- Bleeding disorders such as coagulopathy
- Hypersensitivity to botulinum neurotoxin
- Received botulinum neurotoxin injection in pelvic floor muscles within 6 months before joining
- History of neurological disorders like spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, or myasthenia gravis
- Pregnancy, breastfeeding, or planning pregnancy within one year after last botulinum neurotoxin injection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
Y
Yingchun Zhang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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