Trial Outcomes & Findings for Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain (NCT NCT06352840)
NCT ID: NCT06352840
Last Updated: 2026-02-13
Results Overview
There are four questions that participants will answer from not at all (1) - very much (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more interference and lower scores below 50 meaning less interference.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
3 months
Results posted on
2026-02-13
Participant Flow
1 participant was lost to follow up prior to randomization.
Participant milestones
| Measure |
Monitoring Progress Plus Usual Care
Participants will have access to the monitoring progress web-based symptom monitoring program.
Control Group website: Patients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity).
|
My Pelvic Plan Plus Usual Care
Participants will have access to My Pelvic Plan program.
My Pelvic Plan Website: This is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
45
|
|
Overall Study
3 Months
|
13
|
32
|
|
Overall Study
COMPLETED
|
8
|
27
|
|
Overall Study
NOT COMPLETED
|
16
|
18
|
Reasons for withdrawal
| Measure |
Monitoring Progress Plus Usual Care
Participants will have access to the monitoring progress web-based symptom monitoring program.
Control Group website: Patients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity).
|
My Pelvic Plan Plus Usual Care
Participants will have access to My Pelvic Plan program.
My Pelvic Plan Website: This is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
18
|
Baseline Characteristics
Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain
Baseline characteristics by cohort
| Measure |
Monitoring Progress Plus Usual Care
n=24 Participants
Participants will have access to the monitoring progress web-based symptom monitoring program.
Control Group website: Patients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity).
|
My Pelvic Plan Plus Usual Care
n=45 Participants
Participants will have access to My Pelvic Plan program.
My Pelvic Plan Website: This is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 11.4 • n=6 Participants
|
33.6 years
STANDARD_DEVIATION 9.1 • n=6 Participants
|
33.7 years
STANDARD_DEVIATION 9.5 • n=12 Participants
|
|
Sex/Gender, Customized
Female
|
23 Participants
n=6 Participants
|
45 Participants
n=6 Participants
|
68 Participants
n=12 Participants
|
|
Sex/Gender, Customized
Non-Binary
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
|
Sex/Gender, Customized
Trans Male
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Sex/Gender, Customized
Trans Female
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=6 Participants
|
40 Participants
n=6 Participants
|
62 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
11 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=6 Participants
|
31 Participants
n=6 Participants
|
50 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=6 Participants
|
45 Participants
n=6 Participants
|
69 Participants
n=12 Participants
|
|
PROMIS Pain Interference Short Form (SF)
|
64.5 t-score
STANDARD_DEVIATION 6.6 • n=6 Participants
|
63.5 t-score
STANDARD_DEVIATION 9.3 • n=6 Participants
|
63.8 t-score
STANDARD_DEVIATION 8.5 • n=12 Participants
|
|
PROMIS Pain Intensity 1a Between Groups
|
6.5 t-score
STANDARD_DEVIATION 1.7 • n=6 Participants
|
6.5 t-score
STANDARD_DEVIATION 1.6 • n=6 Participants
|
6.5 t-score
STANDARD_DEVIATION 1.6 • n=12 Participants
|
|
PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups
|
40.8 t-score
STANDARD_DEVIATION 6.7 • n=6 Participants
|
41.7 t-score
STANDARD_DEVIATION 8.4 • n=6 Participants
|
41.4 t-score
STANDARD_DEVIATION 7.8 • n=12 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Data was collected from participants who responded to the 3-month survey.
There are four questions that participants will answer from not at all (1) - very much (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more interference and lower scores below 50 meaning less interference.
Outcome measures
| Measure |
Monitoring Progress Plus Usual Care
n=13 Participants
Participants will have access to the monitoring progress web-based symptom monitoring program.
Control Group website: Patients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity).
|
My Pelvic Plan Plus Usual Care
n=32 Participants
Participants will have access to My Pelvic Plan program.
My Pelvic Plan Website: This is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase.
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups
|
59.2 t-scores
Standard Deviation 6.9
|
63.4 t-scores
Standard Deviation 5.6
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Data was collected from participants who responded to the 3-month survey.
There is one question that participants will answer no pain (0) - worst pain (10). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning higher pain intensity and lower scores below 50 meaning lower pain intensity.
Outcome measures
| Measure |
Monitoring Progress Plus Usual Care
n=13 Participants
Participants will have access to the monitoring progress web-based symptom monitoring program.
Control Group website: Patients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity).
|
My Pelvic Plan Plus Usual Care
n=32 Participants
Participants will have access to My Pelvic Plan program.
My Pelvic Plan Website: This is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase.
|
|---|---|---|
|
PROMIS Pain Intensity 1a Between Groups
|
5.08 t-score
Standard Deviation 1.98
|
6.26 t-score
Standard Deviation 2.00
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Data was collected from participants who responded to the 3-month survey.
There are four questions that participants will answer from I am not all confident (1) - I am very confident (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more confidence in managing symptoms and lower scores below 50 meaning less confidence.
Outcome measures
| Measure |
Monitoring Progress Plus Usual Care
n=13 Participants
Participants will have access to the monitoring progress web-based symptom monitoring program.
Control Group website: Patients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity).
|
My Pelvic Plan Plus Usual Care
n=32 Participants
Participants will have access to My Pelvic Plan program.
My Pelvic Plan Website: This is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase.
|
|---|---|---|
|
PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups
|
42.5 t-score
Standard Deviation 6.9
|
39.7 t-score
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data was collected from participants who responded to the 6-month survey.
There are four questions that participants will answer from not at all (1) - very much (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more interference and lower scores below 50 meaning less interference.
Outcome measures
| Measure |
Monitoring Progress Plus Usual Care
n=8 Participants
Participants will have access to the monitoring progress web-based symptom monitoring program.
Control Group website: Patients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity).
|
My Pelvic Plan Plus Usual Care
n=27 Participants
Participants will have access to My Pelvic Plan program.
My Pelvic Plan Website: This is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase.
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups
|
59.5 t-score
Standard Deviation 10.1
|
60.7 t-score
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data was collected from participants who responded to the 6-month survey.
There is one question that participants will answer no pain (0) - worst pain (10). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning higher pain intensity and lower scores below 50 meaning lower pain intensity.
Outcome measures
| Measure |
Monitoring Progress Plus Usual Care
n=8 Participants
Participants will have access to the monitoring progress web-based symptom monitoring program.
Control Group website: Patients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity).
|
My Pelvic Plan Plus Usual Care
n=27 Participants
Participants will have access to My Pelvic Plan program.
My Pelvic Plan Website: This is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase.
|
|---|---|---|
|
PROMIS Pain Intensity 1a Between Groups
|
5.88 t-score
Standard Deviation 2.42
|
6.38 t-score
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data was collected from participants who responded to the 6-month survey.
There are four questions that participants will answer from I am not all confident (1) - I am very confident (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more confidence in managing symptoms and lower scores below 50 meaning less confidence.
Outcome measures
| Measure |
Monitoring Progress Plus Usual Care
n=8 Participants
Participants will have access to the monitoring progress web-based symptom monitoring program.
Control Group website: Patients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity).
|
My Pelvic Plan Plus Usual Care
n=27 Participants
Participants will have access to My Pelvic Plan program.
My Pelvic Plan Website: This is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase.
|
|---|---|---|
|
PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups
|
42.4 t-score
Standard Deviation 5.8
|
41.7 t-score
Standard Deviation 8.9
|
Adverse Events
Monitoring Progress Plus Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
My Pelvic Plan Plus Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place