Botox for Chronic Pelvic Pain

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06796985
Phase
PHASE1
Status
Recruiting
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Conditions

  • Pelvic Floor Disorders

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Botulinum neurotoxin — DRUG
    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.
  • High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device — 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.

Study Details

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.

Key Dates

Start date
Feb 24, 2025
Status verified
Jul 2025
Primary completion
Mar 22, 2027
Completion
Mar 22, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: Standard injection template followed by HD-sEMG guided injection
    Participants will be in this group for up to 15 months
  • Experimental: Group B: HD-sEMG guided injection followed by standard injection template
    Participants will be in this group for up to 15 months

Primary Outcome Measure

Hypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG) [ Time Frame: 1 month post-injection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Elena Cortizas, MS
[email protected]
305-243-3593
Yingchun Zhang, PhD (PRINCIPAL_INVESTIGATOR)
Raveen Syan, MD (SUB_INVESTIGATOR)
Katherine Amin, MD (SUB_INVESTIGATOR)

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University of Miami· Miami, FL

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