Injection With OnabotulinumtoxinA (Botox) for the Treatment of Chronic Pelvic Pain (NCT02173405) | Clinical Trial Compass
CompletedPhase 1
Injection With OnabotulinumtoxinA (Botox) for the Treatment of Chronic Pelvic Pain
United States10 participantsStarted 2014-08-01
Plain-language summary
This research study because is looking at woman with symptoms of chronic pelvic pain caused by short, tight, and tender pelvic floor muscles (Myofascial Pelvic Pain syndrome). The purpose of this study is to determine whether or not injections with onabotulinumtoxinA (Botox) improve symptoms of pain and tenderness. The drug being studied, Botox is FDA approved for other uses. However, Botox is not FDA approved for the use in myofascial pelvic pain (MPP). Therefore, Botox is considered experimental or research in this study.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Females age 18 years to 65 years
✓. MPP for at least 6 months with pain ranked \> 7/10 by VAS
✓. Able to make medical decisions for herself
✓. Ability to speak and understand English
✓. Ability to follow study instructions and likely to complete all required visits 6 .Must give written informed consent before enrolment in this study
Exclusion criteria
✕. Pelvic onabotulinumA injections within the last 6 months
✕. Pelvic floor physical therapy (PFPT) within the last 1 months
✕. Pelvic surgery within the last 1 year
✕. PVR greater than 150 ml
✕. Presence of interstitial cystitis/ painful bladder syndrome (IC/PBS) by the current The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) criteria 37.
What they're measuring
1
efficacy
Timeframe: at 1 month post treatment versus placebo
Trial details
NCT IDNCT02173405
SponsorUniversity Hospitals Cleveland Medical Center
✕. Evidence of pelvic pathology or other active diagnoses of acute or chronic pain syndromes including endometriosis, chronic cystitis, acute urinary tract infection, vaginitis, pelvic inflammatory disease, etc.
✕. Breastfeeding, pregnant or contemplating pregnancy in the next 1 year or not on a current reliable form of birth control
✕. Patients with known neurological diseases involving impaired neurotransmission, including myasthenia gravis and Charcot-Marie-Tooth disease