Using Botox to relieve chronic pelvic pain
High-Density Surface Electromyography Guided Precision Botulinum Neurotoxin Injections to Manage Chronic Pelvic Floor Pain
This study is testing if Botox injections can help women with chronic pelvic pain feel better than the usual treatments they currently receive.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06796985 on ClinicalTrials.gov |
What this trial studies
This research investigates whether targeted injections of botulinum neurotoxin (Botox) can provide more effective relief for women suffering from pelvic floor disorders compared to standard treatment methods. The study focuses on women aged 18 to 60 who have been diagnosed with interstitial cystitis and experience chronic pelvic pain. Researchers will assess the effects of these precise injections on pain and muscle tension in the pelvic area, aiming to gather data on both the benefits and potential side effects of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 18 to 60 with a clinical diagnosis of interstitial cystitis and chronic pelvic pain.
Not a fit: Patients who may not benefit include males, those outside the age range of 18 to 60, and individuals with certain medical histories such as pelvic malignancy or bleeding disorders.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate chronic pelvic pain for women suffering from pelvic floor disorders.
How similar studies have performed: While this approach is innovative, similar studies using botulinum neurotoxin for pain relief have shown promising results, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Yingchun Zhang, PhD — University of Miami
- Study coordinator: Yingchun Zhang, PhD
- Email: y.zhang@miami.edu
- Phone: 305-284-2445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.