An interventional study of Phallus Length Reducer and Self-assessment of dyspareunia in Endometriosis-related Pain and Dyspareunia Deep, sponsored by BC Women's Hospital & Health Centre. Completed at 1 site in Canada. Open to participants aged 19 Years to 49 Years. Per ClinicalTrials.gov, last updated 2023-12-18.
Sponsored by BC Women's Hospital & Health Centre · Not applicable, Interventional, and Other
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.
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:
920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.
This study's enrollment of 30 is below the median of 67 across 540 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →BC Women's Hospital & Health Centre is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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Patient
Partner
Exclusion Criteria:
Patient
Partner
Participants will be given the OhNut Phallus Length Reducer (PLR) for use during the study period.
Device: Phallus Length Reducer · Other: Self-assessment of dyspareunia
Participants will not have a PLR during the study period. They will be placed on a waitlist to receive the PLR at the end of the study period.
Other: Self-assessment of dyspareunia
Phallus Length Reducer
Also known as: OhNut
Use of a vaginal insert to self assess dyspareunia
Acceptability of the phallus length reducer (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: After 6 weeks of using the PLR
Severity of dyspareunia
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
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
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 (GAD-7)
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 (PHQ-9)
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: Measured at baseline, before and after 6 weeks of using the PLR
Acceptability of self-measurement of dyspareunia
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: After patient self-measurement of dyspareunia is complete (2 times during study)
Validity of self-measurement of dyspareunia
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: 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)
Feasibility - Recruitment
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
Feasibility - Retention
The proportion of enrolled participants who completed the study (retention rate).
Time frame: Up to 6 months
Feasibility - Intervention Fidelity
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.
Time frame: Up to 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2021 to primary completion in Oct 2021, 7 months.
Of 196 non-industry interventional studies with no phase under Endometriosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 44. This study's 7 months is below that.
Counting every sponsor, half of 211 studies reached it within 25 months; a quarter within 13 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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BC Women's Hospital & Health Centre