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| Name | Class |
|---|---|
| American Urogynecologic Society | OTHER |
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This is a single-center, double-blinded, randomized controlled trial evaluating the efficacy of TTNS versus a sham intervention. Both interventions will be performed by participants in their homes after standardized instruction. The primary outcome is a comparison of the mean change in OAB-q scores before and after treatment between the intervention and control groups. Changes in the number of urgency incontinence episodes and an estimation of cost effectiveness will additionally be measured. Intention to treat analysis will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 30-minute treatments, twice weekly x12 weeks |
|
| Sham Group | Sham Comparator | 30-minute treatments, twice weekly x12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous tibial nerve stimulation (TTNS) | Device | TTNS is a non-invasive, surface electrode therapeutic stimulation technique available for home administration that has been proposed as a treatment for overactive bladder. |
| Measure | Description | Time Frame |
|---|---|---|
| Overactive Bladder Questionnaire (OAB-q) | To evaluate the efficacy of a 12-week course of TTNS in reducing urgency urinary incontinence (UUI) symptom bother in the intervention versus sham group. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Voiding diary | To evaluate the efficacy of a 12-week course of TTNS in reducing the frequency of UUI episodes in the intervention versus sham group. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental cost-effectiveness ratio (ICER) | To describe the cost effectiveness of a 12-week course of home-based TTNS therapy using an ICER calculated from the sum of direct medical and indirect non-medical costs relative to health-related quality of life, as measured by the European Quality of Life-5 Dimensions index. | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
Trial is open to biologically female participants only as this is the target population of interest.
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| Name | Affiliation | Role |
|---|---|---|
| Nemi M Shah, MD | University of California San Diego/Kaiser Permanente San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente San Diego | San Diego | California | 92110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39621424 | Derived | Shah NM, Lukacz ES, Ferrante KL, Menefee SA. Transcutaneous Tibial Nerve Stimulation for Urge Incontinence: A Randomized Clinical Trial. Urogynecology (Phila). 2025 Mar 1;31(3):225-233. doi: 10.1097/SPV.0000000000001616. Epub 2024 Dec 13. |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| transcutaneous electrical stimulation (TENS) | Device | The sham intervention is designed to appear almost identical to the TTNS intervention. |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |