Pathways for Patient-centered Diagnosis and Management of Endometriosis-associated Deep Dyspareunia: A Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Acceptability of the phallus length reducer (PLR)
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •19 years of age or older
- •Sexually active with a patient participant who has consented to participate in this study
排除标准
- •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
- •Current use of a PLR
- •Inability to complete English-language questionnaires
结局指标
主要结局
Acceptability of the phallus length reducer (PLR)
时间窗: After 6 weeks of using the PLR
Acceptability of the PLR as measured via questionnaire using a 5 point likert scale (1 = most negative/ worst/ strongly disagree, 5 = most positive/ best/ strongly agree)
次要结局
- Severity of dyspareunia(Measured at baseline, before and after 6 weeks of using the PLR)
- Feasibility - Retention(Up to 6 months)
- Change in sexual function(Measured at baseline, before and after 6 weeks of using the PLR)
- Validity of self-measurement of dyspareunia(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))
- Acceptability of self-measurement of dyspareunia(After patient self-measurement of dyspareunia is complete (2 times during study))
- Change in level of general anxiety (GAD-7)(Measured at baseline, before and after 6 weeks of using the PLR)
- Feasibility - Intervention Fidelity(Up to 6 months)
- Change in sexual distress(Measured at baseline, before and after 6 weeks of using the PLR)
- Change in level of general depression (PHQ-9)(Measured at baseline, before and after 6 weeks of using the PLR)
- Feasibility - Recruitment(Up to 6 months)
研究者
Paul Yong
Principal Investigator
BC Women's Hospital & Health Centre