Objective Pain Measurement Using a Wearable Biosensor and a Mobile Platform in Patients With Endometriosis

NCT04318275 | Completed

• 1 other identifier: CT004-AMY004JG
• Study Type: observational
• Target: 90
• Locations: 3 countries
• Sites: 7

Brief Summary

This study aims to explore a novel objective measurement for endometriosis-related pain. 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, however, is challenging given that pain is difficult to measure and the mechanism by which endometriosis causes pain is not well understood. While previous studies have provided important data on the incidence of pelvic pain and endometriosis, little research has been done to assess both the typology and topology of pelvic pain, pain beyond the pelvis, endometriosis diagnosis, or severity of pain using operative findings and a standardized classification system.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• The concordance between Pain Index and NRS scores during the study period. (Categorised into none, mild, moderate and severe pain)

  Pain Index will be generated via vital sign collected from subjects and processed by Biofourmis's propriety algorithm. Both pain index and NRS will be categorised into None (0), Mild (1-3), Moderate (4-6), and Severe (7-10) pain. Concordance will be measured using unweighted Kappa Statistic for multiple categories with 95% CI. Percentage agreement between the categories will be also calculated by taking the number of concordant pairs divided by the total number of pain episodes.

  12 weeks

Secondary Outcomes (1)

• The correlation between 11-point Pain Index (0-10) and 11-point NRS score (0-10).

  12 weeks

Other Outcomes (13)

• Exploratory Endpoint 1: Correlation between Quality of Life (EQ-5D-5L and EHP-30), Productivity (HRPQ), PROMIS-Fatigue with Sleep Quality and Stress Values calculated using Biofourmis's propriety algorithm.

  12 weeks

• Exploratory Endpoint 2: Trend of Quality of Life over the study period

  12 weeks

• Exploratory Endpoint 3: Trend of Pain Index and NRS categories over the study period

  12 weeks

Eligibility Criteria

• Age: 21 Years - 50 Years
• Gender Eligibility Details: Female on self-representation and confirmed diagnosis of endometriosis by TVUS or MRI.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

124 study participants, aged between 21 to 50 years old, female, who is confirmed diagnosis of endometriosis.

You may qualify if:

• 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: A. Confirmed diagnosis of endometriosis (laparoscopy/laparotomy) performed WITHIN 10 YEARS prior to the study participation.
• B. 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:
• A. Patient is NOT treated with hormonal agents for endometriosis WITHIN 4 WEEKS prior to study participation, and have regular menses (i.e. 21-38 days) within 38 days prior to the study participation.
• B. 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
• Patient has a moderate to severe endometriosis- associated pelvic pain using the Monthly Assessment of Endometriosis Pain within 28 days prior to study participation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biofourmis Singapore Pte Ltd.: lead
• Chugai Pharmaceutical: collaborator

Study Sites (7)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

National University Hospital

Singapore, 119074, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Publications (13)

• Fauconnier A, Chapron C. Endometriosis and pelvic pain: epidemiological evidence of the relationship and implications. Hum Reprod Update. 2005 Nov-Dec;11(6):595-606. doi: 10.1093/humupd/dmi029. Epub 2005 Sep 19.

  PMID: 16172113 BACKGROUND

• Ballard KD, Seaman HE, de Vries CS, Wright JT. Can symptomatology help in the diagnosis of endometriosis? Findings from a national case-control study--Part 1. BJOG. 2008 Oct;115(11):1382-91. doi: 10.1111/j.1471-0528.2008.01878.x. Epub 2008 Aug 19.

  PMID: 18715240 BACKGROUND

• Cox L, Ayers S, Nala K, Penny J. Chronic pelvic pain and quality of life after laparoscopy. Eur J Obstet Gynecol Reprod Biol. 2007 Jun;132(2):214-9. doi: 10.1016/j.ejogrb.2006.04.020. Epub 2006 May 30.

  PMID: 16730874 BACKGROUND

• Kang SB, Chung HH, Lee HP, Lee JY, Chang YS. Impact of diagnostic laparoscopy on the management of chronic pelvic pain. Surg Endosc. 2007 Jun;21(6):916-9. doi: 10.1007/s00464-006-9047-1. Epub 2006 Nov 14.

  PMID: 17103271 BACKGROUND

• Ballard K, Lane H, Hudelist G, Banerjee S, Wright J. Can specific pain symptoms help in the diagnosis of endometriosis? A cohort study of women with chronic pelvic pain. Fertil Steril. 2010 Jun;94(1):20-7. doi: 10.1016/j.fertnstert.2009.01.164. Epub 2009 Apr 1.

  PMID: 19342028 BACKGROUND

• Hsu AL, Sinaii N, Segars J, Nieman LK, Stratton P. Relating pelvic pain location to surgical findings of endometriosis. Obstet Gynecol. 2011 Aug;118(2 Pt 1):223-230. doi: 10.1097/AOG.0b013e318223fed0.

  PMID: 21775836 BACKGROUND

• Renner SP, Boosz AS, Burghaus S, Maihofner C, Beckmann MW, Fasching PA, Jud SM. Visual pain mapping in endometriosis. Arch Gynecol Obstet. 2012 Sep;286(3):687-93. doi: 10.1007/s00404-012-2369-4. Epub 2012 May 9.

  PMID: 22569716 BACKGROUND

• Revised American Society for Reproductive Medicine classification of endometriosis: 1996. Fertil Steril. 1997 May;67(5):817-21. doi: 10.1016/s0015-0282(97)81391-x. No abstract available.

  PMID: 9130884 BACKGROUND

• Bourdel N, Alves J, Pickering G, Ramilo I, Roman H, Canis M. Systematic review of endometriosis pain assessment: how to choose a scale? Hum Reprod Update. 2015 Jan-Feb;21(1):136-52. doi: 10.1093/humupd/dmu046. Epub 2014 Sep 1.

  PMID: 25180023 BACKGROUND

• Yong PJ, Williams C, Bodmer-Roy S, Ezeigwe C, Zhu S, Arion K, Ambacher K, Yosef A, Wong F, Noga H, Britnell S, Yager H, Bedaiwy MA, Brotto LA, Albert AY, Lisonkova S, Allaire C. Prospective Cohort of Deep Dyspareunia in an Interdisciplinary Setting. J Sex Med. 2018 Dec;15(12):1765-1775. doi: 10.1016/j.jsxm.2018.10.005. Epub 2018 Nov 13.

  PMID: 30446474 BACKGROUND

• Practice Committee of the American Society for Reproductive Medicine. Treatment of pelvic pain associated with endometriosis: a committee opinion. Fertil Steril. 2014 Apr;101(4):927-35. doi: 10.1016/j.fertnstert.2014.02.012. Epub 2014 Mar 13.

  PMID: 24630080 BACKGROUND

• Rotondi MA, Donner A. A confidence interval approach to sample size estimation for interobserver agreement studies with multiple raters and outcomes. J Clin Epidemiol. 2012 Jul;65(7):778-84. doi: 10.1016/j.jclinepi.2011.10.019. Epub 2012 May 4.

  PMID: 22560852 BACKGROUND

• Schliep KC, Mumford SL, Peterson CM, Chen Z, Johnstone EB, Sharp HT, Stanford JB, Hammoud AO, Sun L, Buck Louis GM. Pain typology and incident endometriosis. Hum Reprod. 2015 Oct;30(10):2427-38. doi: 10.1093/humrep/dev147. Epub 2015 Aug 11.

  PMID: 26269529 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Maulik Majmudar, M.D.

  Biofourmis Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2019
• First Posted: March 23, 2020
• Study Start: November 6, 2020
• Primary Completion: October 28, 2021
• Study Completion: February 22, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); TW (2); SG (3)