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

NCT ID: NCT04370444

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Background: Endometriosis is a gynecological condition characterized by the abnormal growth of endometrial like tissue outside of the uterus. The condition affects approximately 10% of reproductive-age females and can cause various types of pain, including chronic pelvic pain and deep dyspareunia (pelvic pain with deep sexual intercourse). Research has shown that individuals with endometriosis and dyspareunia have significantly reduced sexual quality of life, lower self-esteem, and impaired sexual function. Qualitative research has also demonstrated that many individuals with dyspareunia feel guilty about their pain, and often continue to engage in intercourse even when the pain is severe.

Aims and Hypotheses:

1. To measure the reduction in deep dyspareunia observed among people using the PLR with their partner. The investigators hypothesize that the PLR will be associated with a reduction in self-reported deep dyspareunia scores among participants randomized to the PLR intervention, compared to participants randomized to the waitlist control group. The measured reduction in deep dyspareunia will be used to power a future definitive trial.
2. To assess the acceptability of the phallus length reducer (PLR) for participants with endometriosis and their partners. The investigators hypothesize that both partners will indicate the PLR is acceptable on the self-reported questionnaire.
3. To explore whether an at-home assessment of dyspareunia is an acceptable and valid alternative to clinical measures. The investigators hypothesize that the at-home assessments of dyspareunia will be acceptable to participants and will yield results that are highly correlated with questionnaire-based and clinical assessments of this pain.

Conditions

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Endometriosis-related Pain Dyspareunia Deep

Keywords

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endometriosis dyspareunia sexual distress buffer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental (PLR)

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

Group Type EXPERIMENTAL

Phallus Length Reducer

Intervention Type DEVICE

Phallus Length Reducer

Self-assessment of dyspareunia

Intervention Type OTHER

Use of a vaginal insert to self assess dyspareunia

Control (Waitlist)

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.

Group Type OTHER

Self-assessment of dyspareunia

Intervention Type OTHER

Use of a vaginal insert to self assess dyspareunia

Interventions

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Phallus Length Reducer

Phallus Length Reducer

Intervention Type DEVICE

Self-assessment of dyspareunia

Use of a vaginal insert to self assess dyspareunia

Intervention Type OTHER

Other Intervention Names

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OhNut

Eligibility Criteria

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Inclusion Criteria

Patient

* 19 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

* 19 years of age or older
* Sexually active with a patient participant who has consented to participate in this study

Exclusion Criteria

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BC Women's Hospital & Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Paul Yong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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BC Women's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 39220343 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36972117 (View on PubMed)

Other Identifiers

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H19-00294

Identifier Type: -

Identifier Source: org_study_id