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| ID | Type | Description | Link |
|---|---|---|---|
| K23HD099283 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The researchers will conduct a pilot randomized trial to assess functional changes with two different remote integrative non-pharmacologic interventions for women with chronic pelvic pain (CPP). The study team will compare a novel web-based, cognitive-behavioral program designed for patients with CPP and a commercially available physical activity remote application. The team aims to gather information about differences in sexual function, physical function, pain, and quality of life.
My Pelvic Plan was determined as a medical device under FDA enforcement discretion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- My Pelvic Plan | Experimental | Patients will be randomized to receive one of two non-pharmacologic interventions. Group 1 will receive access to a novel web-based, cognitive behavioral program. |
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| Group 2- Bend | Active Comparator | Patients will be randomized to receive one of two non-pharmacologic interventions. Group 2 will receive a subscription to a commercially available remote application. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| My Pelvic Plan | Device | My Pelvic Plan is comprised of a self-guided program that combines education on several individual conditions that often contribute to CPP, and will include instruction on cognitive and behavioral restructuring techniques that can help to manage chronic pelvic pain symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Total score on the Female Sexual Function Index (FSFI) | This female sexual function index (FSFI) questionnaire calculator evaluates and monitors woman sexual functioning as well as the level of dysfunction. The FSFI ranges in scores from 2-36 where higher scores indicate more disfunction. (0's may indicate no sexual activity in period in question.) | 8 weeks |
| PROMIS-29 Profile v2.1 physical function domain score | PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including physical function. Higher scores indicate more severity/worse health. | 8 weeks |
| PROMIS-29 Profile v2.1 pain interference domain score | PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including pain interference. Higher scores indicate more severity/worse health. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total score on the Female Sexual Function Index (FSFI) | This female sexual function index (FSFI) questionnaire calculator evaluates and monitors woman sexual functioning as well as the level of dysfunction. The FSFI ranges in scores from 2-36 where higher scores indicate more disfunction. (0's may indicate no sexual activity in period in question.) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Till, MD MPH | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 24, 2025 | Jan 8, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Patients will be blinded to their group assignment. Study team members involved in outcome assessment will be blinded to group assignment.
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| Bend | Behavioral | Bend is a highly rated physical activity application that helps guide users through gentle stretching and yoga poses. |
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| PROMIS-29 Profile v2.1 pain interference domain score | PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including pain interference. Higher scores indicate more severity/worse health. | 4 weeks |
| PROMIS-29 Profile v2.1 physical function domain score | PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including physical function. Higher scores indicate more severity/worse health. | 4 weeks |