Erectile DysfunctionNCT06147791
Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant
A study testing External scrotal drainage in people with Erectile Dysfunction, run by A.O.U. Città della Salute e della Scienza at 2 sites in Italy.
Trial summary
The goal of this prospective randomized study is to demonstrate if the use of an external scrotal drainage in penile prosthetic surgery can reduce the risk of post-operative complications without increase the risk of infections. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- External scrotal drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Oct 2023to 1 Oct 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent signed voluntarily according to the rules of good clinical practice (Declaration of Helsinki) and national regulations (Appendix B).
- Genetically male patient.
- Age ≥ 18 years.
- Patient suffering from ED of variable and/or multifactorial etiology.
- Patient suffering from ED not responsive to iPDE-5.
- Patient suffering from unresponsive or non-tolerant ED
Who cannot join
- Absence of signed written informed consent (Appendix B).
- Age <18 years.
- Genetically female patients.
- Patient with active peno-scrotal infection.
- Patient with active systemic infection.
- Immunosuppressed patient.
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- Patient with haematological pathologies that may cause an increased risk of bleeding.
- Patients suffering from Peyronie's Disease who must undergo simultaneous plaque surgery.
- Any condition or situation that, in the opinion of the investigator, places the patient at significant risk, may confound the results of the study, or significantly interfere with the patient's participation in the study.
- The patient declares that it will be impossible for him to participate in follow-up consultations.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Not yet recruiting
SCDU Urologia
Torino, Torino, 10126
Falcone Mr Marco, Physician, 0116336594, marco.falcone@unito.it
Preto Mr Mirko, Physician, 0116336594, mirko.preto@unito.it
- Recruiting
A.O.U. Città della Salute e della Scienza di Torino
Turin, Turin, 10126
Mirko M Preto, MD, PhD, +39 0116335530, mirko.preto@unito.it
Marco M Falcone, MD, PhD, +39 0116335530, marco.falcone@unito.it
About this study
Official title: Risks and Benefits of Using External Scrotal Drainage in Three-piece Penile Prosthesis Implant: a Prospective Randomized Study
The goal of this prospective randomized study is to demonstrate if the use of an external scrotal drainage in penile prosthetic surgery can reduce the risk of post-operative complications without increase the risk of infections.
Read the detailed description
After being informed about the study, all patients give writted informed consent. After that they will be randomized in two groups (A with drainage, B without drainage) using a random sequence generator. Then the patient will undergo the implantation of a three-component penile prosthesis following peri antibiotic prophylaxis with cephalosporins and aminoglycosides, the antibiotic prophylaxis will be continued on the first post-operative day surgery with a cephalosporin. In the group A it will be positioned at the scrotal level (using surgical access or using a second incision) an external drainage (10 Ch in aspiration) for 24 hours. The drainage will be removed on the first post-operative day. The degree of the hematoma will be determined using a 5-point Likert scales already approved in previous cases. Subsequently patients will carry out periodic check-ups at 7, 15 and 30 days after the operation to evaluate the appearance of hematomas and surgical site infection. After that, they will carry out check-ups every month for the first 3 months, then every 3 months for the first year and finally annually up to the fifth year after the intervention. During the clinical check-ups, it will also be defined the time of use of the penile prosthesis.
- Conditions
- Erectile Dysfunction
- Being tested
- External scrotal drainage
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External scrotal drainageDevice
Application of external scrotal drainage during three-component penile prosthesis placement
| Study group | Role | What they receive |
|---|---|---|
| Group with drainage | Experimental | Not described Receives: Device: External scrotal drainage |
| Group without drainage | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative infectious episodes
Define the number of post-operative infectious episodes in the two study arms.
Measured: One month
Secondary outcomes (8)
Post-surgical hematoma
Define the risk of post-surgical hematoma formation in the two study arms.
Measured: One month
Volume of drained material
Evaluate the volume of drained material in the group with external drainage.
Measured: 24 hour
Manipulation of the activation pump
Define the time elapsed between surgery and subsequent manipulation of the activation pump in the two study arms, usually 2 weeks.
Measured: Up to 12 weeks
Activation of the device
Define the time elapsed between the surgical intervention and the subsequent activation of the device in the two study arms, usually 3 weeks.
Measured: Up to 12 weeks
Use of the penile prosthesis
Define the time elapsed between surgery and the use of the penile prosthesis for sexual activity in the two study arms, usually 4 weeks after surgery.
Measured: Up to 12 weeks
Effectiveness of external drainage in subgroups
Compare, through a sub-analysis, the effectiveness of external drainage in different patient populations: heart patients, diabetics, duration of surgery.
We will test the effectiveness of external drainage in these soubgroups using the IIEF questionnaires.
Measured: Up to 12 months
Effectiveness of external drainage in subgroups
Compare, through a sub-analysis, the effectiveness of external drainage in different patient populations: heart patients, diabetics, duration of surgery.
We will test the effectiveness of external drainage in these soubgroups using the SSIPI questionnaires.
Measured: Up to 12 months
Effectiveness of external drainage in subgroups
Compare, through a sub-analysis, the effectiveness of external drainage in different patient populations: heart patients, diabetics, duration of surgery.
We will test the effectiveness of external drainage in these soubgroups using the QoLPSS questionnaires.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Oct 2023
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A (drainage) vs Group B (no drainage)
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirko Preto, A.O.U. Città della Salute e della Scienza
- Investigators
- Falcone Mr Marco, Physician, Principal investigator, Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147791
- Sponsor's protocol ID
- 833.300
- Status last verified
- Jan 2025
- First submitted
- 14 Oct 2023
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared only among physician participating in the study.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risks and Benefits of Using External Scrotal Drainage in Three-piece Penile Prosthesis Implant: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06147791
- Acronym / sponsor ID
- 833.300
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2033 (estimated)
- First posted
- 28 Nov 2023 (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.
The goal of this prospective randomized study is to demonstrate if the use of an external scrotal drainage in penile prosthetic surgery can reduce the risk of post-operative complications without increase the risk of infections.
Detailed description
After being informed about the study, all patients give writted informed consent. After that they will be randomized in two groups (A with drainage, B without drainage) using a random sequence generator. Then the patient will undergo the implantation of a three-component penile prosthesis following peri antibiotic prophylaxis with cephalosporins and aminoglycosides, the antibiotic prophylaxis will be continued on the first post-operative day surgery with a cephalosporin. In the group A it will be positioned at the scrotal level (using surgical access or using a second incision) an external drainage (10 Ch in aspiration) for 24 hours. The drainage will be removed on the first post-operative day. The degree of the hematoma will be determined using a 5-point Likert scales already approved in previous cases. Subsequently patients will carry out periodic check-ups at 7, 15 and 30 days after the operation to evaluate the appearance of hematomas and surgical site infection. After that, they will carry out check-ups every month for the first 3 months, then every 3 months for the first year and finally annually up to the fifth year after the intervention. During the clinical check-ups, it will also be defined the time of use of the penile prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A (drainage) vs Group B (no drainage)
| Arm | Type | Receives |
|---|---|---|
| Group with drainage | Experimental | Device: External scrotal drainage |
| Group without drainage | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent signed voluntarily according to the rules of good clinical practice (Declaration of Helsinki) and national regulations (Appendix B).
- Genetically male patient.
- Age ≥ 18 years.
- Patient suffering from ED of variable and/or multifactorial etiology.
- Patient suffering from ED not responsive to iPDE-5.
Key exclusion criteria (10 listed)
- Absence of signed written informed consent (Appendix B).
- Age <18 years.
- Genetically female patients.
- Patient with active peno-scrotal infection.
- Patient with active systemic infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External scrotal drainageApplication of external scrotal drainage during three-component penile prosthesis placement | Device | Group with drainage |
Primary outcome
Post-operative infectious episodes
Time frame: One month
Define the number of post-operative infectious episodes in the two study arms.
8 secondary outcomes
Post-surgical hematoma
Time frame: One month
Volume of drained material
Time frame: 24 hour
Manipulation of the activation pump
Time frame: Up to 12 weeks
Activation of the device
Time frame: Up to 12 weeks
Use of the penile prosthesis
Time frame: Up to 12 weeks
Effectiveness of external drainage in subgroups
Time frame: Up to 12 months
Effectiveness of external drainage in subgroups
Time frame: Up to 12 months
Effectiveness of external drainage in subgroups
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No. The data will be shared only among physician participating in the study.
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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.
Falcone Mr Marco, Physician principal investigator
Urology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External scrotal drainage in people with Erectile Dysfunction, run by A.O.U. Città della Salute e della Scienza at 2 sites in Italy.
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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Falcone Mr Marco, Physician (0116336594, marco.falcone@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative infectious episodes (time frame: One month). 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 24 Jan 2025.