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

NCT01323829 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-05-05

No results posted yet for this study

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.

Conditions

  • High Tone Pelvic Floor Dysfunction

Interventions

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.

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Pelvic and Sexual Health Institute

    lead OTHER

Principal Investigators

  • Kristene E Whitmore, MD · Pelvic and Sexual Health Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-07-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01323829 on ClinicalTrials.gov