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NCT Number: NCT01323829

EMG Guided Botulinum Toxin Type A Injections for 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.

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Key information

Conditions

High Tone Pelvic Floor Dysfunction

Age range

18 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pelvic and Sexual Health Institute

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EMG Guidance of Injection

Other

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.

Primary outcomes

  1. To evaluate the use of EMG guidance for Botox A injection for chronic pelvic pain and HTPFD.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Pelvic and Sexual Health Institute

Other

Collaborators

  • Allergan

Registry information

Official study title

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

Acronym: BTXA EMG

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 28, 2011
Registry last updated
May 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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