A Phase 1 interventional study of Botulinum neurotoxin and High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device in Pelvic Floor Disorders, sponsored by University of Miami. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by University of Miami · Phase 1, Interventional, and Treatment
Among 61 studies in Pelvic Floor Disorders with a site in United States — 12 open to participants now, 16 under way, none of them phase 3. Pelvic Floor Disorders · United States.
Among the 61 studies in Pelvic Floor Disorders with a site in United States, this one is the 32nd largest by planned enrollment of the 50 interventional ones, is one of 5 that started in 2025, is one of 2 in phase 1, reaches primary completion later than 7 of the 15 other live ones, and was the 53rd registered.
212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.
This study's planned enrollment of 30 is below the median of 63 across 148 interventional studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →12 of the 61 studies in Pelvic Floor Disorders with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 27 Pelvic Floor Disorders studies recruiting now, 17 (63%) set no upper age limit and 10 (37%) stop at 75 or younger; 0 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 75 Years · female · no healthy volunteers.
The full table on the hub →61 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 5 started in 2025.
Median enrollment 57 across the 50 interventional studies, 133 across the 11 observational. Of the 38 that completed or were terminated, 15 (39%) have results posted.
11 of 61 have an industry lead sponsor. The 10 most frequent:
University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
University of Miami has 1 study filed under Pelvic Floor Disorders — fewer than ten, so there is no comparison to draw.
8 of the studies in Pelvic Floor Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07387315TriHealth Inc.A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections | 2026-11 |
| NCT06689891Yale UniversityVideo-Based Pelvic Floor Muscle Therapy | 2026-12 |
| NCT06111209Brigham and Women's HospitalThe Anabolic Effect of Testosterone on Pelvic Floor Muscles | 2026-12-31 |
| NCT06796985University of MiamiBotox for Chronic Pelvic Pain | 2027-03-22 |
| NCT06798311University of ChicagoReducing Disparities in Urinary Control Symptoms for Minority Women | 2027-05 |
Among the 61 studies in Pelvic Floor Disorders with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be in this group for up to 15 months
Drug: Botulinum neurotoxin · Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device
Participants will be in this group for up to 15 months
Drug: Botulinum neurotoxin · Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device
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.
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.
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.
Time frame: 1 month post-injection
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1 month post-injection
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Mar 2027, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Botulinum Toxins