Botox for Chronic Pelvic Pain

NCT ID: NCT06796985

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-24
• Study Completion Date: 2027-03-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Participants will be in this group for up to 15 months

Group Type: EXPERIMENTAL

Botulinum neurotoxin

Intervention Type: 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

Intervention Type: 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 B: HD-sEMG guided injection followed by standard injection template

Participants will be in this group for up to 15 months

Group Type: EXPERIMENTAL

Botulinum neurotoxin

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Yingchun Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yingchun Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yingchun Zhang, PhD

Role: CONTACT

y.zhang@miami.edu

305-284-2445

Facility Contacts

Elena Cortizas, MS

Role: primary

ecortizas@med.miami.edu

305-243-3593

Other Identifiers

7R01DK133800-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20240022

Identifier Type: -

Identifier Source: org_study_id