NCT04378478

Brief Summary

Wearing a penile ring is justified by international societies of Urology (AFU, EAU, AUA) only for the treatment of erectile dysfunction with vacuum. In this case, it is a constriction rubber band that can only be worn for 30 minutes. Nowadays, wearing a cockring device for recreational purposes can lead to complications secondary to ischemia caused by strangulation of the penis and/or scrotum. The variety of devices and materials used (metallic and/or alloys in particular) sometimes makes it difficult to remove them, requiring expensive surgery and dedicated equipment. There is no official recommendation for the management of these complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

29 days

First QC Date

May 4, 2020

Last Update Submit

November 9, 2020

Conditions

Sexual Dysfunction

Keywords

Penile constriction deviceCockeringEmergency carePenile strangulationUrinary dysfunction

Outcome Measures

Primary Outcomes (1)

  • To draw up recommendations for the emergency management of these complications thanks to a study of the (few) cases treated in France and a review of the literature

    To draw up recommendations for the emergency management of these complications thanks to a study of the (few) cases treated in France and a review of the literature

    1 day

Secondary Outcomes (2)

  • Studying

    1 day

  • Studying

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient has complications secondary to ischemia caused by strangulation of the penis and / or scrotum

You may qualify if:

  • Age ≥ 18 years old
  • Peyronie's disease stable for more than 3 months after 12 to 18 months of evolution
  • Any patient care for this pathology in public or private healthcare hospitals in France

You may not qualify if:

  • \- Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Edouard Fortier, MD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 7, 2020

Study Start

July 1, 2020

Primary Completion

July 30, 2020

Study Completion

November 2, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

FR(1)