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| ID | Type | Description | Link |
|---|---|---|---|
| 7R01DK133800-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Standard injection template followed by HD-sEMG guided injection | Experimental | Participants will be in this group for up to 15 months |
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| Group B: HD-sEMG guided injection followed by standard injection template | Experimental | Participants will be in this group for up to 15 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum neurotoxin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 month post-injection |
| Change in Self-Report Pelvic Symptoms as measured by Global Response Assessment (GRA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingchun Zhang, PhD | Contact | 305-284-2445 | y.zhang@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yingchun Zhang, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
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| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device | Device | 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. |
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Assessment is scored 1-7. Lower score indicates worse symptoms while higher score indicates less symptoms. |
| 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. | Baseline, 1 month post-injection |
| D052801 | Male Urogenital Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |