NCT01323829

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Pelvic and Sexual Health Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-07-01
• Completion: 2013-12-01
• First posted: 2011-03-28
• Last updated: 2014-05-05

Locations

1 site across 1 country: United States