Status:
COMPLETED
Pathways for Patient-centered Diagnosis and Management of Endometriosis-associated Deep Dyspareunia
Lead Sponsor:
BC Women's Hospital & Health Centre
Conditions:
Endometriosis-related Pain
Dyspareunia Deep
Eligibility:
All Genders
19-49 years
Phase:
NA
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)...
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-ag...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04370444
Start Date
March 10 2021
End Date
December 31 2021
Last Update
December 18 2023
Active Locations (1)
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1
BC Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1