Clinical trial NCT06796985: Botox for Chronic Pelvic Pain
Official title: High-Density Surface Electromyography Guided Precision Botulinum Neurotoxin Injections to Manage Chronic Pelvic Floor Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pelvic Floor Disorders
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-01-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG)
timeFrame: 1 month post-injection
Secondary outcomes:
measure: Change in Self-Report Pelvic Pain as measured by Global Response Assessment (GRA)
timeFrame: Baseline, 1 month post-injection
measure: Change in Self-Report Pelvic Symptoms as measured by Global Response Assessment (GRA)
timeFrame: Baseline, 1 month post-injection
measure: Change in Self-Report Pelvic Pain as measured by the Female Genitourinary Index
timeFrame: Baseline, 1 month post-injection
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Yingchun Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: