N/A
N=69
Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain
Chronic Pelvic Pain · Endometriosis
Bottom Line
View on ClinicalTrials.gov: NCT06352840 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups — 59.2; 63.4 t-scores — p=0.038
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- My Pelvic Plan Website (Behavioral); Control Group website (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Michigan
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups |
59.5; 60.7 | 0.682 |
| PRIMARY PROMIS Pain Intensity 1a Between Groups |
5.88; 6.38 | 0.597 |
| PRIMARY PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups |
42.4; 41.7 | 0.836 |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups |
59.5; 60.7 | 0.682 |
| SECONDARY PROMIS Pain Intensity 1a Between Groups |
5.88; 6.38 | 0.597 |
| SECONDARY PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups |
42.4; 41.7 | 0.836 |
Summary
The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP).
The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach.
Eligibility Criteria
Inclusion Criteria
- Participants have chronic pelvic pain, defined by the protocol for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
- Must be currently receiving care within Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain
- Access to internet via computer or smartphone
- English-language proficiency (current version of the website is in English)
Exclusion Criteria
- Underwent gynecologic surgery within 3 months of screening visit
- Plan to undergo gynecologic surgery within 6 months following screening visit
- Pregnant (self-reported) at time of screening visit. Will not exclude patients that become pregnant during the course of the study.
- Severe physical impairment precluding participating in internet-based program (for example, complete blindness or deafness)
- Current psychiatric disorder with history of psychosis (for example, schizophrenia, schizoaffective disorder, delusional disorder),
- Current suicidal ideation or suicide attempt within 2 years of screening visit. The study will screen for severe depression and suicidality at each questionnaire time point and have developed a robust triage and referral plan.
Data sourced from ClinicalTrials.gov (NCT06352840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.