Erectile DysfunctionNCT03466619
Penile Prosthesis in Patients With Erectile Dysfunction
A study testing inflatable penile prosthesis (IPP) in people with Erectile Dysfunction, run by Tanta University at 1 site in Egypt.
Trial summary
Erectile dysfunction (ED) is defined as the persistent inability to attain and or maintain an erection sufficient to permit satisfactory sexual performance Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- inflatable penile prosthesis (IPP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2014to 1 Dec 2027
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients complaining of ED with contraindication or failure of medical treatment
Who cannot join
- Patients lacking manual dexterity or mental abilities necessary to operate the pump
- General contraindications as uncorrectable bleeding tendency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta university - faculty of medicine
Cairo, Elgharbia
Sherief Abdelsalam, lecturer, 00201095159522, Sheriefabdelsalam@yahoo.com
About this study
Official title: Assessment of Safety and Efficacy of Inflatable Penile Prothesis in Patients With Erectile Dysfunction
Erectile dysfunction (ED) is defined as the persistent inability to attain and or maintain an erection sufficient to permit satisfactory sexual performance
Read the detailed description
In the literature, well- designed studies evaluating safety and efficacy of inflatable penile prosthesis (IPP) is lacking. So, this series aimed at investigating this prospectively.
- Conditions
- Erectile Dysfunction
- Being tested
- inflatable penile prosthesis (IPP)
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inflatable penile prosthesis (IPP)Device
Also called penile prosthesis (IPP)
inflatable penile prosthesis (IPP)
| Study group | Role | What they receive |
|---|---|---|
| inflatable penile prosthesis (IPP) | Experimental | inflatable penile prosthesis (IPP) Receives: Device: inflatable penile prosthesis (IPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with improved erectile dysfunction
The number of patients with improved erectile dysfunction
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start1 Nov 2014
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (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
- Not applicable
- Intervention model
- Single group
- Model description
- inflatable penile prosthesis (IPP)
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Khaled Mohamed Hafez Morsy Almekaty, Msc, Principal investigator, Urology Department- Tanta UniversitySamir Abdelhakim Elgamal, Prof, Principal investigator, Urology Department- Tanta UniversitySuks Minhas, Prof, Principal investigator, Professor of urology University College London Hospital(UCLH)London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466619
- Sponsor's protocol ID
- Khaled Hafez
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2018
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Efficacy of Inflatable Penile Prothesis in Patients With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT03466619
- Acronym / sponsor ID
- Khaled Hafez
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Mar 2018 (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.
Erectile dysfunction (ED) is defined as the persistent inability to attain and or maintain an erection sufficient to permit satisfactory sexual performance
Detailed description
In the literature, well- designed studies evaluating safety and efficacy of inflatable penile prosthesis (IPP) is lacking. So, this series aimed at investigating this prospectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- inflatable penile prosthesis (IPP)
| Arm | Type | Receives |
|---|---|---|
| inflatable penile prosthesis (IPP) | Experimental | Device: inflatable penile prosthesis (IPP)inflatable penile prosthesis (IPP) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients complaining of ED with contraindication or failure of medical treatment
Key exclusion criteria (2 listed)
- Patients lacking manual dexterity or mental abilities necessary to operate the pump
- General contraindications as uncorrectable bleeding tendency
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 |
|---|---|---|
| inflatable penile prosthesis (IPP)Also: penile prosthesis (IPP)inflatable penile prosthesis (IPP) | Device | inflatable penile prosthesis (IPP) |
Primary outcome
Number of patients with improved erectile dysfunction
Time frame: 3 years
The number of patients with improved erectile dysfunction
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 15 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Khaled Mohamed Hafez Morsy Almekaty, Msc principal investigator
Urology Department- Tanta University
Samir Abdelhakim Elgamal, Prof principal investigator
Urology Department- Tanta University
Suks Minhas, Prof principal investigator
Professor of urology University College London Hospital(UCLH)London, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inflatable penile prosthesis (IPP) in people with Erectile Dysfunction, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 2 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 15 Mar 2018. 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 Egypt. 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 Sherief Abd-Elsalam, MD (00201095159522, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with improved erectile dysfunction (time frame: 3 years). 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 15 Mar 2018.