EMG Guided Botulinum Toxin Type A Injections for Refractory High Tone Pelvic Floor Dysfunction
Public ClinicalTrials.gov record NCT01323829. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Pilot Study: Botulinum Toxin Type A Injections Into Pelvic Muscles for Patients With Refractory High Tone Pelvic Floor Dysfunction
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01323829
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 79 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2010
- Primary completion
- Jun 30, 2013
- Completion
- Nov 30, 2013
- Last update posted
- May 4, 2014
2010 – 2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pelvic and Sexual Health Institute | Philadelphia | Pennsylvania | 19107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01323829, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 4, 2014 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01323829 live on ClinicalTrials.gov.