High Tone Pelvic Floor DysfunctionBTXA EMGNCT01323829
EMG Guided Botulinum Toxin Type A Injections for Refractory High Tone Pelvic Floor Dysfunction
A study testing EMG Guidance of Injection in people with High Tone Pelvic Floor Dysfunction, run by Pelvic and Sexual Health Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years, women only
- Conditions the study is for
- High Tone Pelvic Floor Dysfunction
- What is being tested?
- EMG Guidance of Injection
- Type of treatment
- Injection or infusion
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pelvic and Sexual Health Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Pilot Study: Botulinum Toxin Type A Injections Into Pelvic Muscles for Patients With 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.
- Conditions
- High Tone Pelvic Floor Dysfunction
- Being tested
- EMG Guidance of Injection
- Keywords
- High Tone Pelvic Floor Dysfunction, Botulinum toxin type A, EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG Guidance of InjectionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the use of EMG guidance for Botox A injection for chronic pelvic pain and HTPFD.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionJul 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Tone Pelvic Floor DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pelvic and Sexual Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Kristene Whitmore, M.D., Pelvic and Sexual Health Institute
- Investigators
- Kristene E Whitmore, MD, Principal investigator, Pelvic and Sexual Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323829
- Sponsor's protocol ID
- BTXA EMG
- Acronym
- BTXA EMG
- Status last verified
- May 2014
- First submitted
- 24 Mar 2011
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Botulinum Toxin Type A Injections Into Pelvic Muscles for Patients With Refractory High Tone Pelvic Floor Dysfunction
- ClinicalTrials.gov ID
- NCT01323829
- Acronym / sponsor ID
- BTXA EMG / BTXA EMG
- Conditions
- High Tone Pelvic Floor Dysfunction
- Keywords
- High Tone Pelvic Floor Dysfunction, Botulinum toxin type A, EMG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Pelvic and Sexual Health InstituteUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Nov 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMG Guidance of InjectionThe 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. | Other | – |
Primary outcome
To evaluate the use of EMG guidance for Botox A injection for chronic pelvic pain and HTPFD.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristene E Whitmore, MD principal investigator
Pelvic and Sexual Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMG Guidance of Injection in people with High Tone Pelvic Floor Dysfunction, run by Pelvic and Sexual Health Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the use of EMG guidance for Botox A injection for chronic pelvic pain and HTPFD. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2014.