Pelvic Floor Disorders
Conditions
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.
Interventions
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.
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.
Sponsors
University of Miami
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTYingchun Zhang, PhD
PRINCIPAL_INVESTIGATORYingchun Zhang, PhD
University of Miami
Outcome results
None listed