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NCT Number: NCT06796985

Botox for Chronic Pelvic Pain

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.

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Elena Cortizas, MS

CONTACT

[email protected]

305-243-3593

Katherine Amin, MD

SUB_INVESTIGATOR

Raveen Syan, MD

SUB_INVESTIGATOR

Yingchun Zhang, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Hypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG)

    Time frame: 1 month post-injection

    The muscle hypertonicity Index measured by using HD-sEMG which is a ratio between the root mean square (RMS) of pelvic floor muscle EMG at rest and contraction.

Secondary outcomes

  1. Change in Self-Report Pelvic Pain as measured by Global Response Assessment (GRA)

    Time frame: Baseline, 1 month post-injection

    Assessment is scored 0-6. Lower score indicates less pain while higher score indicates more pain.

  2. Change in Self-Report Pelvic Symptoms as measured by Global Response Assessment (GRA)

    Time frame: Baseline, 1 month post-injection

    Assessment is scored 1-7. Lower score indicates worse symptoms while higher score indicates less symptoms.

  3. Change in Self-Report Pelvic Pain as measured by the Female Genitourinary Index

    Time frame: Baseline, 1 month post-injection

    Sum score will be collected and scores range from 0-45. Lower score indicates less pain while higher score indicates more pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Yingchun Zhang, PhD

CONTACT

[email protected]

305-284-2445

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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