A Study to Evaluate a Wearable Biosensor and Mobile Platform in Endometriosis Patients

Overview

About this study

The purpose of this study is to explore Biovitals™ wearable device and mobile platform’s ability to detect and quantify various levels of endometriosis pain when used in a home-use setting.

A variety of pain symptoms are associated with endometriosis, including dysmenorrhea, dyspareunia, dysuria, dyschezia and chronic pelvic pain. However, a clear characterization of pain typology and topology in populations with endometriosis, other gynecologic pathology, or a normal pelvis is lacking. Understanding the precise nature of the relationship between pain and endometriosis is important for the clinical management of affected women, given the body of evidence indicating that medical and surgical management for pain associated with endometriosis has been shown to be effective.  Evaluating the relationship between pain and endometriosis is challenging given that pain is difficult to measure and the mechanism by which endometriosis causes pain is not well understood.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Able to give a written Informed Consent Form.
  • Patient who is willing to comply with study restrictions including E4® device management (wearing and charging the device) and Femme Rhythm Patient App Management (pairing E4® device and the patient Femme Rhythm App, and carrying the smartphone for answering questionnaires and data reporting).
  • Female patients aged ≥ 21 and < 50 years.
  • Patient who meets either A or B or both in the following criteria:
    • Confirmed diagnosis of endometriosis (laparoscopy/laparotomy) performed WITHIN 10 YEARS prior to the study participation;
    • Current clinical diagnosis (endometriotic cysts or deep infiltrating endometriosis detected by TVUS, TRUS or MRI) WITHIN 6 MONTHS prior to the study participation.
  • Patient who meets either A or B in the following criteria:
    • Patient is NOT treated with hormonal agents for endometriosis WITHIN 4 WEEKS prior to study participation, and have reqular menses (i.e., 21-38 days) within 38 days prior to the study participation;
    • Patient started hormonal agents for endometriosis, including combined oral contraceptives MORE THAN 8 WEEKS prior to the study participation, or progestins, danazol, GnRH agonists, GnRH antagonists or Progesterone and Levonorgestrel Releasing IUDs MORE THAN 12 WEEKS prior to the study participation, AND stable use of the medication is expected during the study period 6. Patient has a moderate to severe endometriosis associated pelvic pain using the Monthly Assessment of Endometriosis Pain within 28 days prior to study participation.

Exclusion Criteria:

  • Patient is pregnant, or breast feeding or is planning a pregnancy during participation of the study or is less than 6 months postpartum, post-abortion, or post-pregnancy before participation.
  • Patient has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain (e.g., pelvic inflammatory disease).
  • Patient has more than five surgical histories in pelvic area.
  • Patient has a skin disease or condition that would interfere with the collection or interpretation of physiological data obtained through E4®
  • Patient required neuromodulator (a long-acting or immediate release narcotic, or gabapentin) during 3 months prior to the study participation.
  • Patient has a planned surgery during the study.
  • Patient had a surgery within 4 weeks prior to the study participation.
  • Patient has a planned trip overseas during the study participation.
  • Any other reason that, in the judgment of the investigator, would render the subject unsuitable for the study participation.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Tatnai Burnett, M.D.

Open for enrollment

Contact information:

Maureen Lemens R.N.

(507) 293-1487

Lemens.Maureen@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Megan Wasson, D.O.

Open for enrollment

Contact information:

Maureen Lemens R.N.

(507) 293-1487

Lemens.Maureen@mayo.edu

More information

Publications

  • To construct pain maps in order to describe the distribution of pelvic pain in a group of endometriosis patients and endometriosis-free patients, to assess the feasibility of this method. Read More on PubMed
  • To study whether pain location is related to lesion location in women with chronic pelvic pain and biopsy-proven endometriosis. Read More on PubMed
  • To investigate whether different dimensions of chronic pelvic pain are useful in the diagnosis of endometriosis. Read More on PubMed
  • To determine the value of patient-reported symptoms in diagnosing endometriosis. Read More on PubMed
  • Diagnostic laparoscopy is a useful tool, especially when there is no definite anatomical abnormality visible on imaging modalities. We assess the role and clinical impact of diagnostic laparoscopy in the management of women with chronic pelvic pain. Read More on PubMed
  • To examine the long-term relationship between chronic pelvic pain (CPP) and quality of life and see if this is affected by a negative laparoscopy result. Read More on PubMed
  • The relationship between chronic pelvic pain symptoms and endometriosis is unclear because painful symptoms are frequent in women without this pathology, and because asymptomatic forms of endometriosis exist. Our comprehensive review attempts to clarify the links between the characteristics of lesions and the semiology of chronic pelvic pain symptoms. Based on randomized trials against placebo, endometriosis appears to be responsible for chronic pelvic pain symptoms in more than half of confirmed cases. A causal association between severe dysmenorrhoea and endometriosis is very probable. This association is independent of the macroscopic type of the lesions or their anatomical locations and may be related to recurrent cyclic micro-bleeding in the implants. Endometriosis-related adhesions may also cause severe dysmenorrhoea. There are histological and physiopathological arguments for the responsibility of deeply infiltrating endometriosis (DIE) in severe chronic pelvic pain symptoms. DIE-related pain may be in relation with compression or infiltration of nerves in the sub-peritoneal pelvic space by the implants. The painful symptoms caused by DIE present particular characteristics, being specific to involvement of precise anatomical locations (severe deep dyspareunia, painful defecation) or organs (functional urinary tract signs, bowel signs). They can thus be described as location indicating pain. A precise semiological analysis of the chronic pelvic pain symptoms characteristics is useful for the diagnosis and therapeutic management of endometriosis in a context of pain. Read More on PubMed
  • Numerous studies concerning endometriosis and pain have been reported. However, there is no consensus on the best method to evaluate pain in endometriosis and many scales have been used. Moreover, there are only a few descriptions of minimal clinically important differences after treatment (MCID) to evaluate variations in pain. In our study, we aim to identify pain scales used in endometriosis pain treatment, to address their strong and weak points and to define which would be the ideal scale to help clinicians and researchers to evaluate endometriosis-related pain. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20504095

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