Erectile DysfunctionNCT03033082
Evaluation of Marital and Sexual Satisfaction of Wives to Erectile Dysfunction Males
An observational study of Erectile Dysfunction, run by Adam International Hospital.
Trial summary
Erectile Dysfunction (ED), previously known as sexual impotence, is defined as the persistent inability to obtain and/or maintain a penile erection that is hard enough for satisfactory sexual intercourse. The number of reported patients with ED is increasing and it is becoming a real medical problem. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Questionnaire sheets
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Jun 2014
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Males complaining of erectile dysfunction.
Who may be able to join
- Married couples
Who cannot join
- Unmarried couples.
About this study
Official title: Evaluation of Marital and Sexual Satisfaction of Wives to Erectile Dysfunction Males Using Intra Corporeal Injection (Ici). In Correlation to Personality Profile
Erectile Dysfunction (ED), previously known as sexual impotence, is defined as the persistent inability to obtain and/or maintain a penile erection that is hard enough for satisfactory sexual intercourse. The number of reported patients with ED is increasing and it is becoming a real medical problem.
Read the detailed description
Marital satisfaction is a global evaluation of the state of one's marriage or current long-term romantic relationship. This global evaluation can be a reflection of a how happy people are in their marriage in general or a composite of satisfaction with several specific facets of the marital relationship. Sexual health can be described as enjoying and fulfilling sexual desires without harming, physical or psychological, oneself or others. Sexual functioning is an important part of a patient's health and well-being. Patients often seek for treatment late due to embarrassment and commonly with an alternative problem. Sexual and erectile functions are considered important components of men's overall health. The psychosocial impact of ED can lead to depression, loss of self-esteem, and relationship and marital difficulties. Personality is defined as the "distinctive and characteristic patterns of thought, emotion and behavior that define an individual's personal style and influence his or her interaction with the environment".
- Conditions
- Erectile Dysfunction
- Being tested
- Questionnaire sheets
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire sheetsOther
A- Marital satisfaction Index (MSI). Interview (Modified Arabic translation)
B- Sexual Satisfaction Scale:(SSS). The Arabic version of the sexual satisfaction scale was used.
C- International Index of Erectile Function Questionnaire (IIEF-5): For male subjects.
D- The Eysenck Personality Questionnaire (EPQ):
The Arabic version of the EPQ was used.
| Study group | Role | What they receive |
|---|---|---|
| Erectile dysfunction patients | Questionnaire sheets. Receives: Other: Questionnaire sheets | |
| Normal males | Questionnaire sheets. Receives: Other: Questionnaire sheets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marital and sexual satisfaction.
Questionnaire sheets.
Measured: Six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start1 Jan 2014
- Primary completion1 Jun 2014
- Study completion30 Jun 2014
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adam International Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Raef Sadek, Adam International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033082
- Sponsor's protocol ID
- 2014
- Status last verified
- Jan 2017
- First submitted
- 22 Jan 2017
- Last updated
- 26 Jan 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Contact the authors
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Marital and Sexual Satisfaction of Wives to Erectile Dysfunction Males Using Intra Corporeal Injection (Ici). In Correlation to Personality Profile
- ClinicalTrials.gov ID
- NCT03033082
- Acronym / sponsor ID
- 2014
- Conditions
- Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Adam International HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jun 2014 (actual)
- Study completion
- 30 Jun 2014 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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), previously known as sexual impotence, is defined as the persistent inability to obtain and/or maintain a penile erection that is hard enough for satisfactory sexual intercourse. The number of reported patients with ED is increasing and it is becoming a real medical problem.
Detailed description
Marital satisfaction is a global evaluation of the state of one's marriage or current long-term romantic relationship. This global evaluation can be a reflection of a how happy people are in their marriage in general or a composite of satisfaction with several specific facets of the marital relationship. Sexual health can be described as enjoying and fulfilling sexual desires without harming, physical or psychological, oneself or others. Sexual functioning is an important part of a patient's health and well-being. Patients often seek for treatment late due to embarrassment and commonly with an alternative problem. Sexual and erectile functions are considered important components of men's overall health. The psychosocial impact of ED can lead to depression, loss of self-esteem, and relationship and marital difficulties. Personality is defined as the "distinctive and characteristic patterns of thought, emotion and behavior that define an individual's personal style and influence his or her interaction with the environment".
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erectile dysfunction patients | – | Other: Questionnaire sheetsQuestionnaire sheets. |
| Normal males | – | Other: Questionnaire sheetsQuestionnaire sheets. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Males complaining of erectile dysfunction.
Key inclusion criteria (1 listed)
- Married couples
Key exclusion criteria (1 listed)
- Unmarried couples.
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 |
|---|---|---|
| Questionnaire sheetsA- Marital satisfaction Index (MSI). Interview (Modified Arabic translation) B- Sexual Satisfaction Scale:(SSS). The Arabic version of the sexual satisfaction scale was used. C- International Index of Erectile Function Questionnaire (IIEF-5): For male subjects. D- The Eysenck Personality Questionnaire (EPQ): The Arabic version of the EPQ was used. | Other | Erectile dysfunction patients, Normal males |
Primary outcome
Marital and sexual satisfaction.
Time frame: Six months.
Questionnaire sheets.
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 26 Jan 2017.
- Individual participant dataSharing planned: Yes. Contact the authors
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by Adam International Hospital.
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 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Marital and sexual satisfaction. (time frame: Six months.). 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 26 Jan 2017.