Trial results for a study evaluating a novel web-based intervention for Endometriosis and Chronic Pelvic Pain were posted on 2026-02-13, indicating that participants receiving the "My Pelvic Plan" intervention had a significantly higher mean PROMIS Pain Interference score of 63.4 compared to 59.2 in the usual care group.
Background
Endometriosis is a chronic condition often associated with debilitating chronic pelvic pain, significantly impacting quality of life and physical function. Managing chronic pelvic pain typically involves a multi-modal approach, and self-management strategies are increasingly recognized for their potential to empower patients. This study aimed to evaluate a web-based, self-directed intervention designed to provide an integrative self-management approach for patients experiencing chronic pelvic pain, including those with endometriosis, with the hypothesis that it would lead to improvements in pain, physical function, and quality of life.
Trial design
This completed study, identified as Phase NA, enrolled 70 participants with Chronic Pelvic Pain and Endometriosis. The trial evaluated the effectiveness of a web-based, self-management program called "My Pelvic Plan." Participants were randomized into two groups: "My Pelvic Plan Plus Usual Care" and "Monitoring Progress Plus Usual Care." The study hypothesized that the My Pelvic Plan program would demonstrate improvements in pain, physical function, and quality of life. Key outcomes measured included Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference, PROMIS Pain Intensity, and PROMIS Self Efficacy for Managing Symptoms.
Key results
The study reported measurements for several patient-reported outcomes across two distinct assessments:
- PROMIS Pain Interference Short Form (SF) 4a: In the first assessment, the "My Pelvic Plan Plus Usual Care" group had a mean of 63.4 (Standard Deviation 5.6 t-scores) compared to 59.2 (Standard Deviation 6.9 t-scores) in the "Monitoring Progress Plus Usual Care" group, with a statistically significant p-value of 0.038 (t-test, 2 sided). In a subsequent assessment, the "My Pelvic Plan Plus Usual Care" group showed a mean of 60.7 (Standard Deviation 6.2 t-score) versus 59.5 (Standard Deviation 10.1 t-score) for the control group, with a p-value of 0.682.
- PROMIS Pain Intensity 1a: For the first assessment, the "My Pelvic Plan Plus Usual Care" group had a mean of 6.26 (Standard Deviation 2.00 t-score) compared to 5.08 (Standard Deviation 1.98 t-score) in the control group (p-value 0.079). In the subsequent assessment, means were 6.38 (Standard Deviation 2.3 t-score) for the intervention group and 5.88 (Standard Deviation 2.42 t-score) for the control group (p-value 0.597).
- PROMIS Self Efficacy for Managing Symptoms SF 4a: In the first assessment, the "My Pelvic Plan Plus Usual Care" group reported a mean of 39.7 (Standard Deviation 8.4 t-score) versus 42.5 (Standard Deviation 6.9 t-score) for the control group (p-value 0.294). In the subsequent assessment, the intervention group mean was 41.7 (Standard Deviation 8.9 t-score) compared to 42.4 (Standard Deviation 5.8 t-score) for the control group (p-value 0.836).
What this means
The trial results indicate that the "My Pelvic Plan" web-based intervention did not demonstrate a beneficial effect on key patient-reported outcomes for chronic pelvic pain and endometriosis, and in one instance, was associated with a statistically significant increase in pain interference. Specifically, in the first assessment, participants using "My Pelvic Plan Plus Usual Care" reported a significantly higher mean PROMIS Pain Interference score of 63.4 t-scores compared to 59.2 t-scores in the "Monitoring Progress Plus Usual Care" group (p-value 0.038). For other measured outcomes, including pain intensity and self-efficacy for managing symptoms across both assessments, no statistically significant differences were observed between the intervention and control groups. These findings suggest that this particular digital self-management program, as evaluated, did not meet its objective of improving pain or quality of life and was associated with worse pain interference in an initial assessment.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06352840, titled "Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain", were posted on 2026-02-13 on clinicaltrials.gov.