Pelvic PainCII-CPPNCT07066345
Comparing Integrative Interventions for Chronic Pelvic Pain
A study testing My Pelvic Plan and Bend in people with Pelvic Pain, run by Sara Till, MD, MPH at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- My Pelvic Plan and Bend
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to 19 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Scheduled for a new patient visit with the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain.
- Have chronic pelvic pain, defined as moderate to severe pelvic pain that is ≥ 4 on a 0-10 numeric rating scale (worst pain during the day) for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
- Report moderate to severe sexual dysfunction or sexual restriction on CPP clinic intake questionnaire. This will be defined as the patient indicating one of the following responses to a question that asks them to describe their experience relative to sexual activity: my sex life is nearly normal but is very painful, my sex life is severely restricted by pain, my sex life is nearly absent because of pain, pain prevents any self life at all.
- Have access to internet via computer and must have a smartphone
- Willing to download and use the Bend application on their smartphone if they are randomized to that intervention
- English-language proficiency (current version of the My Pelvic Plan website is in English)
Who cannot join
- Pregnancy (at time of screening visit). Participants will be allowed to continue to study if they become pregnant during the study period.
- Severe physical impairment precluding participating in internet-based program or remote application (for example, complete blindness or deafness)
- Medical condition that precludes low-intensity, short-duration physical activity and gentle stretching, including cerebral palsy, severe hip or knee osteoarthritis, severe heart failure, severe Chronic obstructive pulmonary disease (COPD) requiring oxygen use
- Prior care within the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain (seen previously but meets criteria for new patient visit because > 3 year interval since last clinic visit).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
My Pelvic Plan was determined as a medical device under FDA enforcement discretion.
- Conditions
- Pelvic Pain
- Being tested
- My Pelvic Plan, Bend
- Keywords
- Chronic pelvic pain
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Pelvic PlanDevice
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.
BendBehavioural
Bend is a highly rated physical activity application that helps guide users through gentle stretching and yoga poses.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: My Pelvic Plan |
| 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. Receives: Behavioral: Bend |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (3)
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.)
Measured: 4 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start12 Aug 2025
- Primary completion19 Jan 2026
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Till, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Sara Till, MD, MPH, University of Michigan
- Investigators
- Sara Till, MD MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066345
- Sponsor's protocol ID
- HUM00273882
- Other IDs
- K23HD099283
- Acronym
- CII-CPP
- Status last verified
- Jan 2026
- First submitted
- 3 Jul 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Integrative Interventions for Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT07066345
- Acronym / sponsor ID
- CII-CPP / HUM00273882
- Conditions
- Pelvic Pain
- Keywords
- Chronic pelvic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Sara Till, MD, MPHUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 19 Jan 2026 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
My Pelvic Plan was determined as a medical device under FDA enforcement discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1- My Pelvic Plan | Experimental | Device: My Pelvic PlanPatients will be randomized to receive one of two non-pharmacologic interventions. Group 1 will receive access to a novel web-based, cognitive behavioral program. |
| Group 2- Bend | Active comparator | Behavioral: BendPatients will be randomized to receive one of two non-pharmacologic interventions. Group 2 will receive a subscription to a commercially available remote application. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Scheduled for a new patient visit with the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain.
- Have chronic pelvic pain, defined as moderate to severe pelvic pain that is ≥ 4 on a 0-10 numeric rating scale (worst pain during the day) for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
- Report moderate to severe sexual dysfunction or sexual restriction on CPP clinic intake questionnaire. This will be defined as the patient indicating one of the following responses to a question that asks them to describe their experience relative to sexual activity: my sex life is nearly normal but is very painful, my sex life is severely restricted by pain, my sex life is nearly absent because of pain, pain prevents any self life at all.
- Have access to internet via computer and must have a smartphone
- Willing to download and use the Bend application on their smartphone if they are randomized to that intervention
Key exclusion criteria (4 listed)
- Pregnancy (at time of screening visit). Participants will be allowed to continue to study if they become pregnant during the study period.
- Severe physical impairment precluding participating in internet-based program or remote application (for example, complete blindness or deafness)
- Medical condition that precludes low-intensity, short-duration physical activity and gentle stretching, including cerebral palsy, severe hip or knee osteoarthritis, severe heart failure, severe Chronic obstructive pulmonary disease (COPD) requiring oxygen use
- Prior care within the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain (seen previously but meets criteria for new patient visit because > 3 year interval since last clinic visit).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Pelvic PlanMy 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. | Device | Group 1- My Pelvic Plan |
| BendBend is a highly rated physical activity application that helps guide users through gentle stretching and yoga poses. | Behavioural | Group 2- Bend |
Primary outcome
Total score on the Female Sexual Function Index (FSFI)
Time frame: 8 weeks
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.)
PROMIS-29 Profile v2.1 physical function domain score
Time frame: 8 weeks
PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including physical function. Higher scores indicate more severity/worse health.
PROMIS-29 Profile v2.1 pain interference domain score
Time frame: 8 weeks
PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including pain interference. Higher scores indicate more severity/worse health.
3 secondary outcomes
Total score on the Female Sexual Function Index (FSFI)
Time frame: 4 weeks
PROMIS-29 Profile v2.1 pain interference domain score
Time frame: 4 weeks
PROMIS-29 Profile v2.1 physical function domain score
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Till, MD MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Pelvic Plan and Bend in people with Pelvic Pain, run by Sara Till, MD, MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score on the Female Sexual Function Index (FSFI) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.