RECRUITING

Botox for Chronic Pelvic Pain

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Conditions

Pelvic Floor Disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-24
Study Completion:2027-03-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06796985

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.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Females between 18 and 60 years of age
  2. 2. Clinical diagnosis of interstitial cystitis/bladder pain symptoms
  3. 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. 4. Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers
  5. 5. Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination
  6. 6. No botulinum neurotoxin pelvic floor muscle injection treatment within 6 months prior to recruitment
  7. 7. Able to provide informed consent
  1. 1. Males
  2. 2. Women \< 18 and \> 60 years of age
  3. 3. History of pelvic malignancy and sexual transmitted diseases that is currently not in remission
  4. 4. Bleeding disorder such as coagulopathy
  5. 5. Hypersensitivity to botulinum neurotoxin
  6. 6. Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior to recruitment
  7. 7. History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis
  8. 8. Pregnancy, breast feeding or planning to get pregnant within one year after the last botulinum neurotoxin injection.

Contacts and Locations

Study Contact

Yingchun Zhang, PhD
CONTACT
305-284-2445
y.zhang@miami.edu

Principal Investigator

Yingchun Zhang, PhD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Yingchun Zhang, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-24
Study Completion Date2027-03-22

Study Record Updates

Study Start Date2025-02-24
Study Completion Date2027-03-22

Terms related to this study

Additional Relevant MeSH Terms

  • Pelvic Floor Disorders