Using Botox to relieve chronic pelvic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.