Botox for Chronic Pelvic Pain

Description

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

Pelvic Floor Disorders

Study Overview

Study Details

Study overview

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.

High-Density Surface Electromyography Guided Precision Botulinum Neurotoxin Injections to Manage Chronic Pelvic Floor Pain

Botox for Chronic Pelvic Pain

Condition
Pelvic Floor Disorders
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Females between 18 and 60 years of age
  • 2. Clinical diagnosis of interstitial cystitis/bladder pain symptoms
  • 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
  • 1. Males
  • 2. Women \< 18 and \> 60 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.

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Miami,

Yingchun Zhang, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

2027-03-22