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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental (PLR) | Experimental | Participants will be given the OhNut Phallus Length Reducer (PLR) for use during the study period. |
|
| Control (Waitlist) | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phallus Length Reducer | Device | Phallus Length Reducer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | After 6 weeks of using the PLR |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of dyspareunia | Self reported on an 11-point numeric rating scale (0 being no pain, 10 being worst pain imaginable) | Measured at baseline, before and after 6 weeks of using the PLR |
| Change in sexual function |
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Inclusion Criteria:
Patient
Partner
Exclusion Criteria:
Patient
Partner
Participants with endometriosis by definition are of the female sex but may self-identify with any gender identity. We are also recruiting their sexual partners, who may be of either sex, any gender identity.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Women's Hospital | Vancouver | British Columbia | V6H 3N1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39220343 | Derived | Wahl K, Orr NL, Parmar G, Zhang SXJ, MacLeod RGK, Noga H, Albert A, Flannigan R, Brotto LA, Yong PJ. Ohnut vs waitlist control for the self-management of endometriosis-associated deep dyspareunia: a pilot randomized controlled trial. Sex Med. 2024 Aug 31;12(4):qfae049. doi: 10.1093/sexmed/qfae049. eCollection 2024 Aug. | |
| 36972117 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 7, 2025 | |
| Reset | Jan 30, 2025 | |
| Release | Mar 20, 2026 | |
| Reset | Apr 9, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 7, 2025 | Jan 30, 2025 | |||
| Mar 20, 2026 |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Self-assessment of dyspareunia | Other | Use of a vaginal insert to self assess dyspareunia |
|
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).
| 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). | 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). | 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). | 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) | 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) | 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). | Up to 6 months |
| Feasibility - Retention | The proportion of enrolled participants who completed the study (retention rate). | 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. | Up to 6 months |
| Zhang SXJ, MacLeod RGK, Parmar G, Orr NL, Wahl KJ, Noga H, Albert A, Flannigan R, Brotto LA, Yong PJ. Ohnut Versus a Waitlist Control for the Self-management of Endometriosis-Associated Deep Dyspareunia: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 27;12:e39834. doi: 10.2196/39834. |
| Apr 9, 2026 |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |