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Trial record 5 of 19 for:    mahajan

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University Hospital Case Medical Center
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Sangetta Mahajan MD, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT02173405
First received: June 9, 2014
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Myofascial Pain Syndromes
Myofascial Trigger Point Pain
Trigger Point Pain, Myofascial
Drug: OnabotulinumtoxinA
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pelvic Floor Trigger Point Injection With OnabotulinumtoxinA for the Treatment of Severe Myofascial Pelvic Pain (MPP) - A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • efficacy [ Time Frame: at 1 month post treatment versus placebo ] [ Designated as safety issue: No ]
    a 30% reduction of pain and muscular spasm assessed by visual analog scale - VAS


Secondary Outcome Measures:
  • Duration of effect [ Time Frame: 1 month post treatment versus placebo. ] [ Designated as safety issue: No ]
    Reduction of pain and muscular spasm assessed at the 1 month visit by visual analog scale - VAS

  • quality of life [ Time Frame: 1 month post treatment versus placebo ] [ Designated as safety issue: No ]
    assessed by validated patient-filled questionnaires

  • bladder/bowel/sexual functions [ Time Frame: 1 month post treatment versus placebo ] [ Designated as safety issue: No ]
    assessed by validated patient-filled questionnaires

  • complications of therapy [ Time Frame: 1 month post treatment versus placebo ] [ Designated as safety issue: Yes ]
    Assessed by clinical complications of therapy (including urinary retention by PVR and other associated complaints)


Other Outcome Measures:
  • Primary Endpoint: pelvic pain scores and pelvic floor pressures [ Time Frame: 1 month after injection ] [ Designated as safety issue: No ]
    assessed by pelvic pain scores and pelvic floor pressures

  • Secondary Endpoints: treatment duration effect [ Time Frame: 1, 2, 3, 4 and 6 months after injection and/or by a change in treatment ] [ Designated as safety issue: No ]
    assessed by pelvic pain scores after injection and/or by a change in treatment

  • Secondary endpoint: Quality of Life [ Time Frame: at 1, 3, and 6 months post injection ] [ Designated as safety issue: No ]
    assessed by validated patient-filled questionnaires

  • Secondary Endpoints: bladder/bowel functions/sexual activity [ Time Frame: 1, 2, 3, 4 and 6 months post injection ] [ Designated as safety issue: No ]
    assessed by validated patient-filled questionnaires

  • Secondary Endpoints: Urinary complaints [ Time Frame: 1, 2, 3, 4 and 6 months post injection ] [ Designated as safety issue: Yes ]
    assessed by urinary retention defined (PVR >150ml) and other associated complaints


Estimated Enrollment: 40
Study Start Date: June 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Group
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
comparison of OnabotulinumtoxinA with placebo
Other Name: Botox
Placebo Comparator: Placebo group
20 patients randomly assigned to receive 20 ml of saline bilaterally into the same pelvic floor muscles.
Drug: Placebo
comparison of placebo with investigational drug OnabotulinumtoxinA

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 3 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 diagnoses of acute or chronic pain syndromes including endometriosis, fibromyalgia, chronic cystitis, acute urinary tract infection, vulvodynia, vaginitis, pelvic inflammatory disease, Crohn's 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
  11. Blood creatinine level greater than twice the upper limit of normal
  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 3 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02173405

Contacts
Contact: Carmen Czich, RN BSN CCRP 216-983-5124 carmen.czich@uhhospitals.org

Locations
United States, Ohio
University Hospitals Landerbrook Health Center, Urology Not yet recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Carmen Czich, RN BSN CCRP    216-983-5124    carmen.czich@uhhospitals.org   
Sub-Investigator: Adonis Hijaz, MD         
Principal Investigator: Sangeeta Mahajan, MD         
University Hospitals Westlake Health Center, Urology Not yet recruiting
Westlake, Ohio, United States, 44145
Contact: Carmen Czich, RN BSN CCRP    216-983-5124    carmen.czich@uhhospitals.org   
Principal Investigator: Sangetta Mahajan, MD         
Sub-Investigator: Adonis Hijaz, MD         
Sponsors and Collaborators
University Hospital Case Medical Center
Allergan
Investigators
Principal Investigator: Sangetta Mahajan, MD University Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Sangetta Mahajan MD, 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, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT02173405     History of Changes
Other Study ID Numbers: UHCMC IRB 04-13-45, IIT #578
Study First Received: June 9, 2014
Last Updated: June 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
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

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Pelvic Pain
Syndrome
Disease
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pain
Pathologic Processes
Rheumatic Diseases
Signs and Symptoms
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014