Injection With OnabotulinumtoxinA (Botox) for the Treatment of Chronic Pelvic Pain

• Status: Unknown status
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

1. Females age 18 years to 65 years

2. MPP for at least 6 months with pain ranked > 7/10 by VAS

3. Able to make medical decisions for herself

4. Ability to speak and understand English

5. 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:

1. Pelvic onabotulinumA injections within the last 6 months

2. Pelvic floor physical therapy (PFPT) within the last 1 months

3. Pelvic surgery within the last 1 year

4. PVR greater than 150 ml

5. 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.

6. 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.

7. Breastfeeding, pregnant or contemplating pregnancy in the next 1 year or not on a current reliable form of birth control

8. Patients with known neurological diseases involving impaired neurotransmission, including myasthenia gravis and Charcot-Marie-Tooth disease

9. Patients who are on ambulatory anticoagulant therapy, including aspirin, who are unable to discontinue this treatment for 24 hours prior to the bladder injection

10. Women taking aminoglycosides at the time of injection (i.e. Cipro)

12. Uncontrolled clinically significant medical condition other than the condition under investigation 13. Known allergy or sensitivity to any of the components in the study medication 14. Concurrent or past (within 1 months) participation in another investigational drug or device study 15. Any condition or situation that, in the investigators opinion, may put the patients at significant risk, confound the study results, or interfere significantly with the patients participation in the study