NCT04370444

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

Pathways for Patient-centered Diagnosis and Management of Endometriosis-associated Deep Dyspareunia: A Pilot Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: BC Women's Hospital & Health Centre · Academic / Other
• Sex: All
• Age: 19 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Endometriosis-related Pain
• Dyspareunia Deep

Interventions

Type	Name	Description
DEVICE	Phallus Length Reducer	Phallus Length Reducer
OTHER	Self-assessment of dyspareunia	Use of a vaginal insert to self assess dyspareunia

Timeline

• Start date: 2021-03-10
• Primary completion: 2021-10-31
• Completion: 2021-12-31
• First posted: 2020-05-01
• Last updated: 2023-12-18

Locations

1 site across 1 country: Canada