Sexual DysfunctionPCDNCT04378478
Urological Management of Complications of Penile Constriction Devices:
An observational study of Sexual Dysfunction, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sexual Dysfunction
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 2 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient has complications secondary to ischemia caused by strangulation of the penis and / or scrotum
Who may be able to join
- 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
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sexual Dysfunction
- Keywords
- Penile constriction device, Cockering, Emergency care, Penile strangulation, Urinary dysfunction
- Medical subject headings
- Sexual Dysfunction, Physiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (2)
Studying
The co-morbidities of these patients (psychiatric pathologies for example)
Measured: 1 day
Studying
The mid- and long-term urinary and sexual functions of these patients
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Jul 2020
- Primary completion30 Jul 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard Fortier, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378478
- Sponsor's protocol ID
- RECHMPL20_0256
- Acronym
- PCD
- Status last verified
- Nov 2020
- First submitted
- 4 May 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urological Management of Complications of Penile Constriction Devices: French National Retrospective Study and Literature Review
- ClinicalTrials.gov ID
- NCT04378478
- Acronym / sponsor ID
- PCD / RECHMPL20_0256
- Conditions
- Sexual Dysfunction
- Keywords
- Penile constriction device, Cockering, Emergency care, Penile strangulation, Urinary dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient has complications secondary to ischemia caused by strangulation of the penis and / or scrotum
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Studying
Time frame: 1 day
Studying
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edouard Fortier, MD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Dysfunction, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.