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

A Pilot Study: Botulinum Toxin Type A Injections Into Pelvic Muscles for Patients With Refractory High Tone Pelvic Floor Dysfunction

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.

Study Overview

• Status: Completed
• Conditions: High Tone Pelvic Floor Dysfunction
• Intervention / Treatment: Other: EMG Guidance of Injection

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Pelvic and Sexual Health Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the use of EMG guidance for Botox A injection for chronic pelvic pain and HTPFD.	6 months

Collaborators and Investigators

• Sponsor: Pelvic and Sexual Health Institute
• Collaborators: Allergan
• Investigators: Principal Investigator: Kristene E Whitmore, MD, Pelvic and Sexual Health Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: March 24, 2011
• First Submitted That Met QC Criteria: March 24, 2011
• First Posted (Estimate): March 28, 2011

Study Record Updates

• Last Update Posted (Estimate): May 5, 2014
• Last Update Submitted That Met QC Criteria: May 2, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: EMG; Botulinum toxin type A; High Tone Pelvic Floor Dysfunction
• Other Study ID Numbers: BTXA EMG