BC Women's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
NCT Number: NCT04370444
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.
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Notify Me19 year–49 year
All sexes
Interventional
Not applicable
Vancouver, British Columbia, V6H 3N1, Canada
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient
Partner
Exclusion criteria
Patient
Partner
Phallus Length Reducer
Other names: OhNut
Use of a vaginal insert to self assess dyspareunia
Time frame: 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)
Time frame: Measured at baseline, before and after 6 weeks of using the PLR
Self reported on an 11-point numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Time frame: Measured at baseline, before and after 6 weeks of using the PLR
Change in sexual function as measured by Female Sexual Function Index (FSFI). This a brief, self-administered questionnaire to assess key dimensions of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and are scored from 1 to 5 (with 1 being the lowest report of desire and 5 being the highest).
Time frame: Measured at baseline, before and after 6 weeks of using the PLR
Change in sexual distress as measured in Female Sexual Distress Scale-Revised (FSDS-R) This is a self-administered measure of female personal distress associated with sexual dysfunction. There are 13 questions. The range for each question is 0 (Never) to 4 (Always).
Time frame: Measured at baseline, before and after 6 weeks of using the PLR
Change in level of general anxiety as measured using the General Anxiety Disorder - 7 questionnaire. There are 7 questions. The range for each question is 0 (not at all) to 4 (nearly every day).
Time frame: Measured at baseline, before and after 6 weeks of using the PLR
Change in level of general depression as measured using the Patient Health Questionnaire- 9 questionnaire. There are 9 questions. The range for each question is 0 (not at all) to 4 (nearly every day).
Time frame: After patient self-measurement of dyspareunia is complete (2 times during study)
Acceptability of self-measurement of dyspareunia will be measured via questionnaire using 5 point likert scale (1 = most negative/ worst/ strongly disagree, 5 = most positive/ best/ strongly agree)
Time frame: 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)
Dyspareunia score from the self-measurement will be compared to records of dyspareunia scores from physician performed pelvic exams. (11 point scale, 0 being no pain, 10 being worst pain imaginable)
Time frame: Up to 6 months
The proportion of potentially eligible individuals who were successfully contacted by the study team (response rate); the proportion of contacted individuals who were ineligible, declined to participate, and consented; the number of couples enrolled per month of active recruitment (recruitment rate).
Time frame: Up to 6 months
The proportion of enrolled participants who completed the study (retention rate).
Time frame: Up to 6 months
To evaluate protocol adherence we documented: the proportion of sexual encounters using the Ohnut per couple in the intervention group during the intervention period (intervention fidelity) and the proportion of missing data.
BC Women's Hospital & Health Centre
Other
Pathways for Patient-centered Diagnosis and Management of Endometriosis-associated Deep Dyspareunia: A Pilot Randomized Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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