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

NCT04370444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-18

No results posted yet for this study

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 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.

Conditions

  • Endometriosis-related Pain
  • Dyspareunia Deep

Interventions

DEVICE

Phallus Length Reducer

Phallus Length Reducer

OTHER

Self-assessment of dyspareunia

Use of a vaginal insert to self assess dyspareunia

Sponsors & Collaborators

  • BC Women's Hospital & Health Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2021-10-31
Completion
2021-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04370444 on ClinicalTrials.gov