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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02173405
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : May 10, 2022
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Sangetta Mahajan MD, University Hospitals Cleveland Medical Center

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.

Condition or disease Intervention/treatment Phase
Myofascial Pain Syndromes Myofascial Trigger Point Pain Trigger Point Pain, Myofascial Drug: OnabotulinumtoxinA Drug: Placebo Phase 1

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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
Actual Study Start Date : August 1, 2014
Actual Primary Completion Date : September 1, 2015
Actual Study Completion Date : September 1, 2016


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. efficacy [ Time Frame: at 1 month post treatment versus placebo ]
    a 30% reduction of pain and muscular spasm assessed by visual analog scale - VAS


Secondary Outcome Measures :
  1. Duration of effect [ Time Frame: 1 month post treatment versus placebo. ]
    Reduction of pain and muscular spasm assessed at the 1 month visit by visual analog scale - VAS

  2. quality of life [ Time Frame: 1 month post treatment versus placebo ]
    assessed by validated patient-filled questionnaires

  3. bladder/bowel/sexual functions [ Time Frame: 1 month post treatment versus placebo ]
    assessed by validated patient-filled questionnaires

  4. complications of therapy [ Time Frame: 1 month post treatment versus placebo ]
    Assessed by clinical complications of therapy (including urinary retention by PVR and other associated complaints)


Other Outcome Measures:
  1. Primary Endpoint: pelvic pain scores and pelvic floor pressures [ Time Frame: 1 month after injection ]
    assessed by pelvic pain scores and pelvic floor pressures

  2. Secondary Endpoints: treatment duration effect [ Time Frame: 1, 2, 3, 4 and 6 months after injection and/or by a change in treatment ]
    assessed by pelvic pain scores after injection and/or by a change in treatment

  3. Secondary endpoint: Quality of Life [ Time Frame: at 1, 3, and 6 months post injection ]
    assessed by validated patient-filled questionnaires

  4. Secondary Endpoints: bladder/bowel functions/sexual activity [ Time Frame: 1, 2, 3, 4 and 6 months post injection ]
    assessed by validated patient-filled questionnaires

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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173405


Locations
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United States, Ohio
University Case Medical Center
Cleveland, Ohio, United States, 44106
University Hospitals Landerbrook Health Center, Urology
Mayfield Heights, Ohio, United States, 44124
University Hospitals Westlake Health Center, Urology
Westlake, Ohio, United States, 44145
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Allergan
Investigators
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Principal Investigator: Sangetta Mahajan, MD University Hospitals Cleveland Medical Center
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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 Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02173405    
Other Study ID Numbers: UHCMC IRB 04-13-45
IIT #578 ( Other Identifier: Allergan INC )
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Keywords provided by Sangetta Mahajan MD, University Hospitals Cleveland 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:
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Myofascial Pain Syndromes
Fibromyalgia
Pelvic Pain
Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents