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Endometriosis-related PainNCT04370444

Pathways for Patient-centered Diagnosis and Management of Endometriosis-associated Deep Dyspareunia

A study testing Phallus Length Reducer and Self-assessment of dyspareunia in people with Endometriosis-related Pain and Dyspareunia Deep, run by BC Women's Hospital & Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 to 49 years
Conditions the study is for
Endometriosis-related Pain, Dyspareunia Deep
What is being tested?
Phallus Length Reducer and Self-assessment of dyspareunia
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
10 Mar 2021to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 49 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • BC Women's Hospital

    Vancouver, British Columbia, V6H 3N1

Other trials in Canada

About this study

Official title: Pathways for Patient-centered Diagnosis and Management of Endometriosis-associated Deep Dyspareunia: A Pilot Randomized Trial

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.

Read the 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.
Being tested
Phallus Length Reducer, Self-assessment of dyspareunia
Keywords
endometriosis, dyspareunia, sexual distress, buffer
Medical subject headings
Endometriosis, Dyspareunia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phallus Length ReducerDevice

    Also called OhNut

    Phallus Length Reducer

  • Self-assessment of dyspareuniaOther

    Use of a vaginal insert to self assess dyspareunia

Study groups in NCT04370444
Study groupRoleWhat they receive
Experimental (PLR)ExperimentalParticipants will be given the OhNut Phallus Length Reducer (PLR) for use during the study period.
Receives: Device: Phallus Length Reducer; Other: Self-assessment of dyspareunia
Control (Waitlist)OtherParticipants 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.
Receives: Other: Self-assessment of dyspareunia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: After 6 weeks of using the PLR

Secondary outcomes (10)

  1. Severity of dyspareunia

    Self reported on an 11-point numeric rating scale (0 being no pain, 10 being worst pain imaginable)

    Measured: Measured at baseline, before and after 6 weeks of using the PLR

  2. 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).

    Measured: Measured at baseline, before and after 6 weeks of using the PLR

  3. 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: Measured at baseline, before and after 6 weeks of using the PLR

  4. 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: Measured at baseline, before and after 6 weeks of using the PLR

  5. 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: Measured at baseline, before and after 6 weeks of using the PLR

  6. 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)

    Measured: After patient self-measurement of dyspareunia is complete (2 times during study)

  7. 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)

    Measured: 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)

  8. 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).

    Measured: Up to 6 months

  9. Feasibility - Retention

    The proportion of enrolled participants who completed the study (retention rate).

    Measured: Up to 6 months

  10. 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.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2020
  2. Study start10 Mar 2021
  3. Primary completion31 Oct 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04370444
Sponsor's protocol ID
H19-00294
Status last verified
Dec 2023
First submitted
23 Apr 2020
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39220343

  • 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.

    PubMed 36972117

Questions about this trial

What is this clinical trial studying?

A study testing Phallus Length Reducer and Self-assessment of dyspareunia in people with Endometriosis-related Pain and Dyspareunia Deep, run by BC Women's Hospital & Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of the phallus length reducer (PLR) (time frame: After 6 weeks of using the PLR). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04370444, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.

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