Comparing Integrative Interventions for Chronic Pelvic Pain

NCT ID: NCT07066345

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-12
• Study Completion Date: 2025-11-30

Brief 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). 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.

Conditions

Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1- My Pelvic Plan

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.

Group Type: EXPERIMENTAL

My Pelvic Plan

Intervention Type: 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.

Group 2- Bend

Patients will be randomized to receive one of two non-pharmacologic interventions. Group 2 will receive a subscription to a commercially available remote application.

Group Type: ACTIVE_COMPARATOR

Bend

Intervention Type: BEHAVIORAL

Bend is a highly rated physical activity application that helps guide users through gentle stretching and yoga poses.

Interventions

My Pelvic Plan

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.

Intervention Type: DEVICE

Bend

Bend is a highly rated physical activity application that helps guide users through gentle stretching and yoga poses.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Sara Till, MD, MPH

OTHER

Sponsor Role: lead

Responsible Party

Sara Till, MD, MPH

Assistant Professor of Obstetrics and Gynecology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sara Till, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vilmarie Carmona

Role: CONTACT

vilmarie@umich.edu

269-760-7317

Sara Till

Role: CONTACT

tillsa@med.umich.edu

734-232-1333

Other Identifiers

K23HD099283

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00273882

Identifier Type: -

Identifier Source: org_study_id