What is the mechanism of action of this treatment?

Common treatments for endometriosis include hormonal therapies such as estrogen-progestin contraceptives, GnRH agonists and antagonists, and progestins like dienogest. These treatments work by reducing estrogen levels, which in turn decreases the growth and activity of endometrial tissue, thereby alleviating pain and other symptoms. Behavioral interventions, like the PelvicSense 3-month online program, aim to manage pain through psychological and physical therapy techniques, addressing the chronic pain and improving quality of life. This matters for endometriosis patients as it provides a multifaceted approach to pain management, combining medical and behavioral strategies to enhance overall outcomes.

What side effects are associated with this type of intervention?

Behavioral interventions like the PelvicSense 3-month online program generally have minimal side effects, primarily involving the time commitment and potential initial discomfort as patients adapt to new routines. Common treatments for endometriosis, such as hormonal therapies (e.g., combined oral contraceptives, GnRH agonists like goserelin and nafarelin), can have side effects including mood swings, weight gain, headaches, and decreased bone density. Surgical treatments may involve risks such as infection, bleeding, and potential damage to surrounding organs. It is essential to discuss these options and their side effects with a healthcare provider to determine the best individualized treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for endometriosis, primarily focusing on hormonal therapies such as combined estrogen-progestin contraceptives, GnRH agonists, and progestins, which help manage pain and reduce disease activity. Non-hormonal treatments, including NSAIDs, are also commonly used for pain management. While behavioral interventions like the PelvicSense 3-month online program are not specifically mentioned as FDA-approved treatments, they represent an emerging approach to managing endometriosis-related pain and improving patient outcomes through non-pharmacological means.

What other types of research exist?

Promising alternatives to the PelvicSense 3-month online program for endometriosis patients include: 1) The 'Physio-EndEA' supervised and adapted therapeutic exercise program, which focuses on lumbopelvic stabilization and tolerance to exertion to improve health-related quality of life. 2) Pelvic floor myofascial physical therapy, which has shown significant symptom improvement in patients with pelvic floor muscle tenderness. 3) Elagolix, a medication that has demonstrated significant improvements in health-related quality of life by reducing dyspareunia and other pain symptoms associated with endometriosis.

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Behavioral Intervention

Online Program for Endometriosis Pain

N/A

Recruiting

Led By Caroline Pukall, PhD

Research Sponsored by Dr. Caroline Pukall

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after the end of the program

Awards & highlights

No Placebo-Only Group

Summary

This trial will test an online program called PelvicSense designed to help people with endometriosis manage their pain. Participants will follow the program remotely and continue their usual treatments. The study aims to see if this program can improve pain and other health outcomes.

Who is the study for?

This trial is for adults over 18 who speak English and have been diagnosed with endometriosis, experiencing pain for at least three months. Participants will continue their usual treatment while being involved in the study.

What is being tested?

The PelvicSense online program's effectiveness on reducing pain and improving sexual outcomes in individuals with endometriosis is being tested. The study spans over a period of six months including assessments before, after the 3-month program, and a follow-up.

What are the potential side effects?

Since PelvicSense is an educational intervention rather than a medication, it may not have typical drug side effects; however, participants might experience discomfort or emotional distress when addressing sensitive topics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after the end of the program

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after the end of the program

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after the end of the program for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain intensity

Secondary study objectives

Pain catastrophizing

Other study objectives

Pain self-efficacy

Sexual distress

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 3 month PelvicSense(R) programExperimental Treatment1 Intervention

PelvicSense® is a home-based physiotherapy program integrating multiple techniques, including relaxation, breathing, stretching, strengthening and at-home manual therapy. This program also educates participants about the anatomy and physiology of the pelvis and teaches strategies to strengthen the mind-muscle connection to the pelvis.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for endometriosis include hormonal therapies such as estrogen-progestin contraceptives, GnRH agonists and antagonists, and progestins like dienogest. These treatments work by reducing estrogen levels, which in turn decreases the growth and activity of endometrial tissue, thereby alleviating pain and other symptoms. Behavioral interventions, like the PelvicSense 3-month online program, aim to manage pain through psychological and physical therapy techniques, addressing the chronic pain and improving quality of life. This matters for endometriosis patients as it provides a multifaceted approach to pain management, combining medical and behavioral strategies to enhance overall outcomes.

State of the art, new treatment strategies, and emerging drugs for non-hormonal treatment of endometriosis: a systematic review of randomized control trials.Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist.Pain and endometriosis: Etiology, impact, and therapeutics.