Pathways for Patient-centered Diagnosis and Management of Endometriosis-associated Deep Dyspareunia

NCT04370444 | Completed

• 1 other identifier: H19-00294
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the acceptability and effectiveness of two tools that may help address the management of deep dyspareunia: 1) A phallus length reducer (PLR, brand name: Ohnut), consisting of 4 interconnected silicone rings worn externally over the penetrating object to reduce pain with deep penetration by allowing adjustable limitation of penetration depth, and 2) A vaginal insert for at home self-assessment of the extent and severity of deep dyspareunia.

Conditions

Endometriosis-related Pain; Dyspareunia Deep

Keywords

endometriosis; dyspareunia; sexual distress; buffer

Outcome Measures

Primary Outcomes (1)

• Acceptability of the phallus length reducer (PLR)

  Acceptability of the PLR as measured via questionnaire using a 5 point likert scale (1 = most negative/ worst/ strongly disagree, 5 = most positive/ best/ strongly agree)

  After 6 weeks of using the PLR

Secondary Outcomes (10)

• Severity of dyspareunia

  Measured at baseline, before and after 6 weeks of using the PLR

• Change in sexual function

  Measured at baseline, before and after 6 weeks of using the PLR

• Change in sexual distress

  Measured at baseline, before and after 6 weeks of using the PLR

• Change in level of general anxiety (GAD-7)

  Measured at baseline, before and after 6 weeks of using the PLR

• Change in level of general depression (PHQ-9)

  Measured at baseline, before and after 6 weeks of using the PLR

Study Arms (2)

Experimental (PLR)

EXPERIMENTAL

Participants will be given the OhNut Phallus Length Reducer (PLR) for use during the study period.

Device: Phallus Length Reducer; Other: Self-assessment of dyspareunia

Control (Waitlist)

OTHER

Participants will not have a PLR during the study period. They will be placed on a waitlist to receive the PLR at the end of the study period.

Other: Self-assessment of dyspareunia

Interventions

Phallus Length Reducer DEVICE

Phallus Length Reducer

Also known as: OhNut

Experimental (PLR)

Self-assessment of dyspareunia OTHER

Use of a vaginal insert to self assess dyspareunia

Control (Waitlist); Experimental (PLR)

Eligibility Criteria

• Age: 19 Years - 49 Years
• Gender Eligibility Details: Participants with endometriosis by definition are of the female sex but may self-identify with any gender identity. We are also recruiting their sexual partners, who may be of either sex, any gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient
• to 49 years of age
• Monogamous sexual partnership
• Sexually active or not sexually active due to deep dyspareunia
• Self-reported deep dyspareunia score ≥ 4/10
• Sexual partner who is willing to participate
• Willing to engage in penetrative sex at least once during the duration of the study
• Partner
• years of age or older
• Sexually active with a patient participant who has consented to participate in this study

You may not qualify if:

• Patient
• Superficial dyspareunia score ≥ 4/10 (This is a potentially confounding variable; the PLR is not expected to affect introital pain)
• Current use of a PLR
• Inability to complete English-language questionnaires
• GAD-7 score ≥ 15
• PHQ-9 score ≥ 15
• Intense fear/anxiety in anticipation of, during, or as a result of vaginal intercourse
• Partner
• Current use of a PLR
• Inability to complete English-language questionnaires

Sponsors & Collaborators

• BC Women's Hospital & Health Centre: lead

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (2)

• Wahl K, Orr NL, Parmar G, Zhang SXJ, MacLeod RGK, Noga H, Albert A, Flannigan R, Brotto LA, Yong PJ. Ohnut vs waitlist control for the self-management of endometriosis-associated deep dyspareunia: a pilot randomized controlled trial. Sex Med. 2024 Aug 31;12(4):qfae049. doi: 10.1093/sexmed/qfae049. eCollection 2024 Aug.

  PMID: 39220343 DERIVED

• Zhang SXJ, MacLeod RGK, Parmar G, Orr NL, Wahl KJ, Noga H, Albert A, Flannigan R, Brotto LA, Yong PJ. Ohnut Versus a Waitlist Control for the Self-management of Endometriosis-Associated Deep Dyspareunia: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 27;12:e39834. doi: 10.2196/39834.

  PMID: 36972117 DERIVED

MeSH Terms

Conditions

Endometriosis; Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: May 1, 2020
• Study Start: March 10, 2021
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)