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

NCT02173405 | Completed Phase 1

• 2 other identifiers: UHCMC IRB 04-13-45IIT #578
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Myofascial Pain Syndromes; Myofascial Trigger Point Pain; Trigger Point Pain, Myofascial

Keywords

Myofascial Pain Syndromes; Pelvic pain; Trigger points + injections; Myofascial Trigger Point Pain; Trigger Point Pain, Myofascial; Botulinum Toxins, Type A; Botulinum Neurotoxin A; Botulinum Toxin Type A; Clostridium botulinum A Toxin; Clostridium Botulinum Toxin Type A; Oculinum

Outcome Measures

Primary Outcomes (1)

• efficacy

  a 30% reduction of pain and muscular spasm assessed by visual analog scale - VAS

  at 1 month post treatment versus placebo

Secondary Outcomes (4)

• Duration of effect

  1 month post treatment versus placebo.

• quality of life

  1 month post treatment versus placebo

• bladder/bowel/sexual functions

  1 month post treatment versus placebo

• complications of therapy

  1 month post treatment versus placebo

Other Outcomes (5)

• Primary Endpoint: pelvic pain scores and pelvic floor pressures

  1 month after injection

• Secondary Endpoints: treatment duration effect

  1, 2, 3, 4 and 6 months after injection and/or by a change in treatment

• Secondary endpoint: Quality of Life

  at 1, 3, and 6 months post injection

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

20 patients randomly assigned to receive 100 U onabotulinumtoxinA reconstituted in 20 ml saline sequentially injected bilaterally into the pubococcygeus, iliococcygeus, coccygeus, obturator internus, and piriformis muscles.

Drug: OnabotulinumtoxinA

Placebo group

PLACEBO COMPARATOR

20 patients randomly assigned to receive 20 ml of saline bilaterally into the same pelvic floor muscles.

Drug: Placebo

Interventions

OnabotulinumtoxinA DRUG

comparison of OnabotulinumtoxinA with placebo

Also known as: Botox

Treatment Group

Placebo DRUG

comparison of placebo with investigational drug OnabotulinumtoxinA

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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
• Patients who are on ambulatory anticoagulant therapy, including aspirin, who are unable to discontinue this treatment for 24 hours prior to the bladder injection
• Women taking aminoglycosides at the time of injection (i.e. Cipro)
• \. 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Allergan: collaborator

Study Sites (3)

University Case Medical Center

Cleveland, Ohio, 44106, United States

Location

University Hospitals Landerbrook Health Center, Urology

Mayfield Heights, Ohio, 44124, United States

Location

University Hospitals Westlake Health Center, Urology

Westlake, Ohio, 44145, United States

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes; Pelvic Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Sangetta Mahajan, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor & Head Division of Female Pelvic Medicine/Reconstructive Surgery/Obstetrics/Gynecology/Urology and Director of joint fellowship in Female Pelvic Medicine andReconstructive Surgery in the Departments of Obstetrics/Gynecology/Urology

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 25, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2016
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

US (3)