Botox for Chronic Pelvic Pain

Launched by UNIVERSITY OF MIAMI · Jan 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether targeted injections of Botox can help relieve chronic pelvic pain better than the usual treatment methods. The researchers aim to help women who experience pelvic floor disorders, specifically those with bladder pain or discomfort that has lasted for six months or more. They want to see how effective and safe these Botox injections are for managing pain and muscle tension in the pelvic area.

To participate, women must be between 18 and 60 years old and have a diagnosis related to bladder pain or pelvic discomfort. They should also have specific muscle tenderness in the pelvic area and not have received Botox injections for at least six months. Participants can expect to receive targeted Botox injections and will be monitored for any effects, both positive and negative. This trial is currently recruiting participants, and it provides an opportunity to contribute to research that could improve treatment options for pelvic pain.

Gender

FEMALE

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.