Urological Management of Complications of Penile Constriction Devices:

Sexual Dysfunction Clinical Trial

— PCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378478
• Other study ID #: RECHMPL20_0256
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: November 2, 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Sexual Dysfunction

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Studying	The co-morbidities of these patients (psychiatric pathologies for example)	1 day
Secondary	Studying	The mid- and long-term urinary and sexual functions of these patients	1 day