Pelvic Floor DisordersPhase 1NCT06796985
Botox for Chronic Pelvic Pain
A Phase 1 study testing Botulinum neurotoxin and High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device in people with Pelvic Floor Disorders, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to find out if precise, targeted injection of botulinum neurotoxin (commonly known as Botox) provides better relief of pelvic floor hypertonicity and pain than the standard method being used. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Botulinum neurotoxin and High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2025to 22 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females between 18 and 75 years of age
- Clinical diagnosis of chronic pelvic pain
- Complaints of pain, pressure, or discomfort in the bladder and/or pelvic area for the past 6 months or more, associated with lower urinary tract symptoms (such as frequency of urination), in the absence of other explanation of the symptoms (e.g., UTI) *
- Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers
- Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination
- No botulinum neurotoxin pelvic floor muscle injection treatment within 6 months prior to recruitment
- Able to provide informed consent
Who cannot join
- Males
- Women < 18 and > 76 years of age
- History of pelvic malignancy and sexual transmitted diseases that is currently not in remission
- Bleeding disorder such as coagulopathy
- Hypersensitivity to botulinum neurotoxin
- Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior to recruitment
- History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis
- Pregnancy, breast feeding or planning to get pregnant within one year after the last botulinum neurotoxin injection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Elena Cortizas, MS, 305-243-3593, ecortizas@med.miami.edu
Yingchun Zhang, PhD
About this study
Official title: High-Density Surface Electromyography Guided Precision Botulinum Neurotoxin Injections to Manage Chronic Pelvic Floor Pain
The purpose of this research study is to find out if precise, targeted injection of botulinum neurotoxin (commonly known as Botox) provides better relief of pelvic floor hypertonicity and pain than the standard method being used. The researchers want to better understand the effects (good and bad) of targeted botulinum neurotoxin injections in women with pelvic floor disorders.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Botulinum neurotoxin, High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum neurotoxinDrug
Botulinum neurotoxin will be injected into the pelvic floor muscles following either a standard template (standard injection arm), or guided using high-density surface EMG (guided arm). Participants will receive this drug twice throughout the duration of the study. Approximately 200 units of botulinum neurotoxin will be administered per injection.
High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical deviceDevice
A personalized, precision botulinum neurotoxin injection guidance medical device, utilizing an intra-vaginal high-density surface EMG system to optimize the treatment outcomes in chronic pelvic pain (CPP) management. The device will be used five times during the study. Each use will last approximately ten minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Standard injection template followed by HD-sEMG guided injection | Experimental | Participants will be in this group for up to 15 months Receives: Drug: Botulinum neurotoxin; Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device |
| Group B: HD-sEMG guided injection followed by standard injection template | Experimental | Participants will be in this group for up to 15 months Receives: Drug: Botulinum neurotoxin; Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG)
The muscle hypertonicity Index measured by using HD-sEMG which is a ratio between the root mean square (RMS) of pelvic floor muscle EMG at rest and contraction.
Measured: 1 month post-injection
Secondary outcomes (3)
Change in Self-Report Pelvic Pain as measured by Global Response Assessment (GRA)
Assessment is scored 0-6. Lower score indicates less pain while higher score indicates more pain.
Measured: Baseline, 1 month post-injection
Change in Self-Report Pelvic Symptoms as measured by Global Response Assessment (GRA)
Assessment is scored 1-7. Lower score indicates worse symptoms while higher score indicates less symptoms.
Measured: Baseline, 1 month post-injection
Change in Self-Report Pelvic Pain as measured by the Female Genitourinary Index
Sum score will be collected and scores range from 0-45. Lower score indicates less pain while higher score indicates more pain.
Measured: Baseline, 1 month post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start24 Feb 2025
- Primary completion22 Mar 2027 (estimated)
- Study completion22 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingchun Zhang, University of Miami
- Investigators
- Yingchun Zhang, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796985
- Sponsor's protocol ID
- 20240022
- Other IDs
- 7R01DK133800-03
- Status last verified
- Jun 2026
- First submitted
- 22 Jan 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Density Surface Electromyography Guided Precision Botulinum Neurotoxin Injections to Manage Chronic Pelvic Floor Pain
- ClinicalTrials.gov ID
- NCT06796985
- Acronym / sponsor ID
- 20240022
- Conditions
- Pelvic Floor Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 22 Mar 2027 (estimated)
- Study completion
- 22 Mar 2027 (estimated)
- First posted
- 28 Jan 2025 (actual)
- 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.
The purpose of this research study is to find out if precise, targeted injection of botulinum neurotoxin (commonly known as Botox) provides better relief of pelvic floor hypertonicity and pain than the standard method being used. The researchers want to better understand the effects (good and bad) of targeted botulinum neurotoxin injections in women with pelvic floor disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Standard injection template followed by HD-sEMG guided injection | Experimental | Drug: Botulinum neurotoxin, Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical deviceParticipants will be in this group for up to 15 months |
| Group B: HD-sEMG guided injection followed by standard injection template | Experimental | Drug: Botulinum neurotoxin, Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical deviceParticipants will be in this group for up to 15 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Females between 18 and 75 years of age
- Clinical diagnosis of chronic pelvic pain
- Complaints of pain, pressure, or discomfort in the bladder and/or pelvic area for the past 6 months or more, associated with lower urinary tract symptoms (such as frequency of urination), in the absence of other explanation of the symptoms (e.g., UTI) *
- Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers
- Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination
Key exclusion criteria (8 listed)
- Males
- Women < 18 and > 76 years of age
- History of pelvic malignancy and sexual transmitted diseases that is currently not in remission
- Bleeding disorder such as coagulopathy
- Hypersensitivity to botulinum neurotoxin
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 |
|---|---|---|
| Botulinum neurotoxinBotulinum neurotoxin will be injected into the pelvic floor muscles following either a standard template (standard injection arm), or guided using high-density surface EMG (guided arm). Participants will receive this drug twice throughout the duration of the study. Approximately 200 units of botulinum neurotoxin will be administered per injection. | Drug | Group A: Standard injection template followed by HD-sEMG guided injection, Group B: HD-sEMG guided injection followed by standard injection template |
| High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical deviceA personalized, precision botulinum neurotoxin injection guidance medical device, utilizing an intra-vaginal high-density surface EMG system to optimize the treatment outcomes in chronic pelvic pain (CPP) management. The device will be used five times during the study. Each use will last approximately ten minutes. | Device | Group A: Standard injection template followed by HD-sEMG guided injection, Group B: HD-sEMG guided injection followed by standard injection template |
Primary outcome
Hypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG)
Time frame: 1 month post-injection
The muscle hypertonicity Index measured by using HD-sEMG which is a ratio between the root mean square (RMS) of pelvic floor muscle EMG at rest and contraction.
3 secondary outcomes
Change in Self-Report Pelvic Pain as measured by Global Response Assessment (GRA)
Time frame: Baseline, 1 month post-injection
Change in Self-Report Pelvic Symptoms as measured by Global Response Assessment (GRA)
Time frame: Baseline, 1 month post-injection
Change in Self-Report Pelvic Pain as measured by the Female Genitourinary Index
Time frame: Baseline, 1 month post-injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Yingchun Zhang, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Botulinum neurotoxin and High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device in people with Pelvic Floor Disorders, run by University of Miami 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yingchun Zhang, PhD (305-284-2445, y.zhang@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG) (time frame: 1 month post-injection). 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 17 Jun 2026.