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OpenTrials
Completed

NCT Number: NCT04378478

Urological Management of Complications of Penile Constriction Devices:

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.

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Key information

Conditions

Sexual Dysfunction Genital Diseases Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Refusal to participate

Treatment and study plan

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

    Time frame: 1 day

    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

Secondary outcomes

  1. Studying

    Time frame: 1 day

    The co-morbidities of these patients (psychiatric pathologies for example)

  2. Studying

    Time frame: 1 day

    The mid- and long-term urinary and sexual functions of these patients

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Urological Management of Complications of Penile Constriction Devices: French National Retrospective Study and Literature Review

Acronym: PCD

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 7, 2020
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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