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Recruiting NCT06796985

Botox for Chronic Pelvic Pain

Phase I Interventional Pelvic Floor Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Botulinum neurotoxin, High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device.
Who it may be relevant to
Registry conditions: Pelvic Floor Disorders. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Drug Botulinum neurotoxin
    Botulinum neurotoxin will be injected into the pelvic floor muscles following either a standard template (standard injection arm), or guided using high-density surface EMG (guided arm). Participants will receive this drug twice throughout the duration of the study. Approximately 200 units of botulinum neurotoxin will be administered per injection.
  • Device High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device
    A personalized, precision botulinum neurotoxin injection guidance medical device, utilizing an intra-vaginal high-density surface EMG system to optimize the treatment outcomes in chronic pelvic pain (CPP) management. The device will be used five times during the study. Each use will last approximately ten minutes.

Primary outcome measures

  • Hypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG) [Time frame: 1 month post-injection]
Secondary outcome measures (3)
  • Change in Self-Report Pelvic Pain as measured by Global Response Assessment (GRA) [Time frame: Baseline, 1 month post-injection]
  • Change in Self-Report Pelvic Symptoms as measured by Global Response Assessment (GRA) [Time frame: Baseline, 1 month post-injection]
  • Change in Self-Report Pelvic Pain as measured by the Female Genitourinary Index [Time frame: Baseline, 1 month post-injection]

Eligibility criteria

Inclusion criteria

  • Females between 18 and 75 years of age
  • Clinical diagnosis of chronic pelvic pain
  • 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) \*
  • Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers
  • Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination
  • No botulinum neurotoxin pelvic floor muscle injection treatment within 6 months prior to recruitment
  • Able to provide informed consent

Exclusion criteria

  • Males
  • Women < 18 and > 76 years of age
  • History of pelvic malignancy and sexual transmitted diseases that is currently not in remission
  • Bleeding disorder such as coagulopathy
  • Hypersensitivity to botulinum neurotoxin
  • Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior to recruitment
  • History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis
  • Pregnancy, breast feeding or planning to get pregnant within one year after the last botulinum neurotoxin injection.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT06796985 · 20240022 · 7R01DK133800-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗