Botox for Chronic Pelvic Pain

NCT06796985 | Recruiting Phase 1 DMC FDA Drug FDA Device

• 2 other identifiers: 202400227R01DK133800-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Baseline, 1 month post-injection

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

  Baseline, 1 month post-injection

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

  Baseline, 1 month post-injection

Study Arms (2)

Group A: Standard injection template followed by HD-sEMG guided injection

EXPERIMENTAL

Participants will be in this group for up to 15 months

Drug: Botulinum neurotoxin; Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device

Group B: HD-sEMG guided injection followed by standard injection template

EXPERIMENTAL

Participants will be in this group for up to 15 months

Drug: Botulinum neurotoxin; Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device

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.

Group A: Standard injection template followed by HD-sEMG guided injection; Group B: HD-sEMG guided injection followed by standard injection template

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.

Group A: Standard injection template followed by HD-sEMG guided injection; Group B: HD-sEMG guided injection followed by standard injection template

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Yingchun Zhang, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingchun Zhang, PhD

CONTACT

305-284-2445; y.zhang@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: February 24, 2025
• Primary Completion (Estimated): March 22, 2027
• Study Completion (Estimated): March 22, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)