Botox for Chronic Pelvic Pain

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

Study Overview

• Status: Recruiting
• Conditions: Pelvic Floor Disorders
• Intervention / Treatment: Drug: Botulinum neurotoxin; Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yingchun Zhang, PhD; Phone Number: 305-284-2445; Email: y.zhang@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Elena Cortizas, MS; Phone Number: 305-243-3593; Email: ecortizas@med.miami.edu
      • Principal Investigator: Yingchun Zhang, PhD
      • Sub-Investigator: Raveen Syan, MD
      • Sub-Investigator: Katherine Amin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Females between 18 and 75 years of age
2. Clinical diagnosis of chronic pelvic pain
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

Exclusion Criteria:

1. Males
2. Women < 18 and > 76 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Standard injection template followed by HD-sEMG guided injection; Participants will be in this group for up to 15 months	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.
Experimental: Group B: HD-sEMG guided injection followed by standard injection template; Participants will be in this group for up to 15 months	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG)	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.	1 month post-injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-Report Pelvic Pain as measured by Global Response Assessment (GRA)	Assessment is scored 0-6. Lower score indicates less pain while higher score indicates more pain.	Baseline, 1 month post-injection
Change in Self-Report Pelvic Symptoms as measured by Global Response Assessment (GRA)	Assessment is scored 1-7. Lower score indicates worse symptoms while higher score indicates less symptoms.	Baseline, 1 month post-injection
Change in Self-Report Pelvic Pain as measured by the Female Genitourinary Index	Sum score will be collected and scores range from 0-45. Lower score indicates less pain while higher score indicates more pain.	Baseline, 1 month post-injection

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Yingchun Zhang, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): March 22, 2027
• Study Completion (Estimated): March 22, 2027

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Pelvic Floor Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: 20240022; 7R01DK133800-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes