Clinical trial NCT04370444: Pathways for Patient-centered Diagnosis and Management of Endometriosis-associated Deep Dyspareunia
Official title: Pathways for Patient-centered Diagnosis and Management of Endometriosis-associated Deep Dyspareunia: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis-related Pain
Dyspareunia Deep
Keywords: endometriosis
dyspareunia
sexual distress
buffer
Lead sponsor: BC Women's Hospital & Health Centre
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of the phallus length reducer (PLR)
timeFrame: After 6 weeks of using the PLR
Secondary outcomes:
measure: Severity of dyspareunia
timeFrame: Measured at baseline, before and after 6 weeks of using the PLR
measure: Change in sexual function
timeFrame: Measured at baseline, before and after 6 weeks of using the PLR
measure: Change in sexual distress
timeFrame: Measured at baseline, before and after 6 weeks of using the PLR
measure: Change in level of general anxiety (GAD-7)
timeFrame: Measured at baseline, before and after 6 weeks of using the PLR
measure: Change in level of general depression (PHQ-9)
timeFrame: Measured at baseline, before and after 6 weeks of using the PLR
measure: Acceptability of self-measurement of dyspareunia
timeFrame: After patient self-measurement of dyspareunia is complete (2 times during study)
measure: Validity of self-measurement of dyspareunia
timeFrame: Assessment and questionnaire administered 2 times, each one week apart, during the first 4 weeks of the study (to be assessed at week 2 and 3 of participant's menstrual cycle, which may vary)
measure: Feasibility - Recruitment
timeFrame: Up to 6 months
measure: Feasibility - Retention
timeFrame: Up to 6 months
measure: Feasibility - Intervention Fidelity
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
References: