Botox for Chronic Pelvic Pain

Phase 1

Recruiting

• Conditions: Pelvic Floor Disorders
• Interventions: Drug: Botulinum neurotoxin; Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device

• Registration Number: NCT06796985
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-28
• Study Start: 2025-02-24
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Primary Completion: 2027-03-22
• Study Completion: 2027-03-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Females between 18 and 60 years of age
2. Clinical diagnosis of interstitial cystitis/bladder pain symptoms
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 > 60 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A: Standard injection template followed by HD-sEMG guided injection	Botulinum neurotoxin	Participants will be in this group for up to 15 months
Group A: Standard injection template followed by HD-sEMG guided injection	High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device	Participants will be in this group for up to 15 months
Group B: HD-sEMG guided injection followed by standard injection template	Botulinum neurotoxin	Participants will be in this group for up to 15 months
Group B: HD-sEMG guided injection followed by standard injection template	High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device	Participants will be in this group for up to 15 months

Primary Outcome Measures

Name	Time	Method
Hypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG)	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 Outcome Measures

Name	Time	Method
Change in Self-Report Pelvic Pain as measured by Global Response Assessment (GRA)	Baseline, 1 month post-injection	Assessment is scored 0-6. Lower score indicates less pain while higher score indicates more pain.
Change in Self-Report Pelvic Symptoms as measured by Global Response Assessment (GRA)	Baseline, 1 month post-injection	Assessment is scored 1-7. Lower score indicates worse symptoms while higher score indicates less symptoms.
Change in Self-Report Pelvic Pain as measured by the Female Genitourinary Index	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States