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

This study is ongoing, but not recruiting participants.

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: December 2, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 24, 2011

Last Updated Date

December 2, 2011

Start Date ^ICMJE

November 2010

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01323829 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

High Tone Pelvic Floor Dysfunction

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01323829

Other Study ID Numbers ^ICMJE

BTXA EMG

Has Data Monitoring Committee

Responsible Party

Kristene Whitmore, M.D., Pelvic and Sexual Health Institute

Study Sponsor ^ICMJE

Pelvic and Sexual Health Institute

Collaborators ^ICMJE

Allergan

Investigators ^ICMJE

Principal Investigator:

Kristene E Whitmore, MD

Pelvic and Sexual Health Institute

Information Provided By

Pelvic and Sexual Health Institute

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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