Botox for Chronic Pelvic Pain

University of Miami

Status and phase: Enrolling; Phase 1

Conditions: Pelvic Floor Disorders

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06796985

7R01DK133800-03 (U.S. NIH Grant/Contract)

20240022

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

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

Experimental group

Description:

Participants will be in this group for up to 15 months

Treatment:

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

Drug: Botulinum neurotoxin

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

Experimental group

Description:

Participants will be in this group for up to 15 months

Treatment:

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

Drug: Botulinum neurotoxin