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CompletedNCT01323829BTXA EMGUpdated May 5, 2014

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

An interventional study of EMG Guidance of Injection in High Tone Pelvic Floor Dysfunction, sponsored by Pelvic and Sexual Health Institute. Completed at 1 site in United States. Open to female participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2014-05-05.

Sponsored by Pelvic and Sexual Health Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years to 79 Years
Sex
Female
01

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.

02

Conditions studied

  • High Tone Pelvic Floor Dysfunction

Keywords

  • High Tone Pelvic Floor Dysfunction
  • Botulinum toxin type A
  • EMG
03

In context

Lead sponsor

Pelvic and Sexual Health Institute is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Interventions

  • OtherEMG 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.

06

What researchers measure

Primary outcomes

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

    Time frame: 6 months

07

Study locations

1 site
  • Pelvic and Sexual Health Institute
    Philadelphia, Pennsylvania 19107, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01323829
Lead sponsor
Pelvic and Sexual Health Institute
Collaborators
Allergan
Responsible party
Kristene Whitmore, M.D. (Medical Director, Pelvic and Sexual Health Institute) — Principal investigator
First posted
Mar 28, 2011
Start date
Nov 2010
Primary completion
Jul 2013
Completion
Dec 2013
Last update
May 5, 2014

Study contacts

Kristene E Whitmore, MD
principal investigator · Pelvic and Sexual Health Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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