Actively Recruiting

Phase 1
Age: 18Years - 75Years
FEMALE
NCT06796985

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

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

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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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