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

BC Women's Hospital & Health Centre

Status: Completed

Conditions: Dyspareunia Deep; Endometriosis-related Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04370444

H19-00294

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 19 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental (PLR)

Experimental group

Description:

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

Treatment:

Device: Phallus Length Reducer

Other: Self-assessment of dyspareunia

Control (Waitlist)

Other group

Description:

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.

Treatment:

Other: Self-assessment of dyspareunia