Urological Management of Complications of Penile Constriction Devices: (PCD)

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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Studying	The co-morbidities of these patients (psychiatric pathologies for example)	1 day
Studying	The mid- and long-term urinary and sexual functions of these patients	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ACTUAL): July 30, 2020
• Study Completion (ACTUAL): November 2, 2020

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (ACTUAL): May 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Emergency care; Urinary dysfunction; Penile constriction device; Cockering; Penile strangulation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: RECHMPL20_0256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No