EMG Guided Botulinum Toxin Type A Injections for Refractory High Tone Pelvic Floor Dysfunction (BTXA EMG)

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Kristene Whitmore, M.D., Pelvic and Sexual Health Institute
ClinicalTrials.gov Identifier:
NCT01323829
First received: March 24, 2011
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

This is a prospective, pilot, longitudinal study to evaluate the use of EMG guidance for Botox A injection for chronic pelvic pain and HTPFD. The objective of this study is to determine the efficacy of injecting botulinum toxin type A into pelvic floor muscles that are high tone. Patients who have been diagnosed with high tone pelvic floor muscle dysfunction and have failed other treatments will be eligible to participate in this study. Study related procedures will include perineometry readings. Patients will be required to complete 7 questionnaires for this study. These include visual analog scale (scale from 0-10) for pain (VAS), the O'Leary-Sant urinary symptoms and problem questionnaires (ICSI/ICPI), Pelvic Floor Distress Inventory 20 (PFDI-20), the Female Sexual Distress Scale (FSDS), Global Response Assessment Scale and the SF-12 quality of life scale. The use of the EMG guidance is the experimental part of the study. We will perform EMG Needle testing in order to pin-point the best location for the patients Botox injections. This is a prospective, pilot, longitudinal study to evaluate the effect of Botox A injection for chronic pelvic pain and HTPFD.


Condition Intervention
High Tone Pelvic Floor Dysfunction
Other: EMG Guidance of Injection

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study: Botulinum Toxin Type A Injections Into Pelvic Muscles for Patients With Refractory High Tone Pelvic Floor Dysfunction

Resource links provided by NLM:


Further study details as provided by Pelvic and Sexual Health Institute:

Primary Outcome Measures:
  • To evaluate the use of EMG guidance for Botox A injection for chronic pelvic pain and HTPFD. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: November 2010
Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: EMG Guidance of Injection
    The use of the EMG guidance is the experimental part of the study. We will perform EMG Needle testing in order to pin-point the best location for the patients Botox injections.
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must be diagnosed with High Tone Pelvic Floor Dysfunction(HTPMFD).
  • Participant must have tried and failed at least one other conventional mode of therapy for HTPMFD.
  • Participant must be a female at least 18 years of age.
  • Participant must give written informed consent to participate in this study.
  • Participant must be able to make decisions for herself.
  • Participant must not be undergoing another procedure at the time of BTX A injection.

Exclusion Criteria:

  • Participant is male.
  • Patient has a history of past BTX A use
  • Patient has had pelvic organ prolapse repair
  • Participant is pregnant or intends to get pregnant during the study period or is breastfeeding.
  • Participant is unwilling or unable (because of long distance from office) to follow-up.
  • Participant has a neuro-modulator device implanted.
  • Participant has a known bleeding disorder or is on anticoagulation.
  • Participant has a known hypersensitivity to BTX A.
  • Participant has a pre-existing neuromuscular disorder such as amytrophic lateral sclerosis, motor neuropathy, myasthenia gravis or Lambert-Eaton syndrome.
  • Participant with skin infection at the perineum at the site of injection.
  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: NCT01323829

Locations
United States, Pennsylvania
Pelvic and Sexual Health Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Pelvic and Sexual Health Institute
Allergan
Investigators
Principal Investigator: Kristene E Whitmore, MD Pelvic and Sexual Health Institute
  More Information

No publications provided

Responsible Party: Kristene Whitmore, M.D., Medical Director, Pelvic and Sexual Health Institute
ClinicalTrials.gov Identifier: NCT01323829     History of Changes
Other Study ID Numbers: BTXA EMG
Study First Received: March 24, 2011
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pelvic and Sexual Health Institute:
High Tone Pelvic Floor Dysfunction
Botulinum toxin type A
EMG

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014