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| ID | Type | Description | Link |
|---|---|---|---|
| MOH_2023-04-16_012540 | Registry Identifier | Israel Ministry of Healt Clinical Trials Registry (in Hebrew) |
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The goal of this clinical trial is to learn about the feasibility of inducing contraction of the anal sphincter by transcutaneous neuromuscular electrical stimulation in patients with fecal incontinence.
The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | All participant will be exposed to the full stimulation protocol 2 different protocols using 2 different electrode arrays will be studied in random order. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous neuromuscular electrical stimulation | Device | Transcutaneous electrical stimulation will be delivered to the anal sphincter and anal resting and squeezing pressures as a result of the stimulation will be recorded for different stimulation protocols using approved electrotherapy units |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulation intensity levels | The stimulation intensity levels measured in milliamperes (mA) required to induce changes in anal sphincter pressures measured by manometry. | During exposure to electrical stimulation 5 min |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal tolerability to neuromuscular transcutaneous stimulation measured as the current in mA causing discomfort of at least 7 on a scale of 0 to 10 points. | The stimulation intensity levels measured as the current in milliamperes (mA) causing a discomfort level of 7 out of 10 point or the current at which a participant asks to stop the stimulation. | During exposure to electrical stimulation 5 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Diseases Institute, Shaare Zedek Medical Center | Jerusalem | 90301 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35039916 | Background | Livovsky DM, Koslowsky B, Goldin E, Lysy J. External kinesiology tape for improvement in fecal incontinence symptom bother in women: a pilot study. Int Urogynecol J. 2022 Oct;33(10):2859-2868. doi: 10.1007/s00192-021-05050-z. Epub 2022 Jan 18. | |
| 11175371 | Background | Riedy LW, Chintam R, Walter JS. Use of a neuromuscular stimulator to increase anal sphincter pressure. Spinal Cord. 2000 Dec;38(12):724-7. doi: 10.1038/sj.sc.3101088. |
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Data will not be anonymized; thus, due to privacy rights, we will consider the ethical and legal implications of sharing the data, providing that a relevant request for data is received.
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Safety of neuromuscular transcutaneous stimulation measured as the proportion of patients reporting or presenting with adverse events during the study attributed or not to the use of electrical stimulation | The Rate of Adverse Events (e.g., pain, skin reactions, prolonged abnormal sensation after stopping the stimulation, etc.) during the study attributed or not to the use of electrical stimulation | Until discharge, assessed up to 7 days |