Erectile Dysfunction Following Radical ProstatectomyNCT05272995
Recalled International Index of Erectile Function-5 Collected Post Prostatectomy in Assessing Preop Erectile Function
An observational study of Erectile Dysfunction Following Radical Prostatectomy, run by University Hospital of Patras at 1 site in Greece.
Trial summary
The accurate assessment of erectile function before radical prostatectomy, using validated questionnaires like IIEF-5, is crucial to evaluate postoperative changes in erectile function, as the preoperative erectile function is a prognostic factor for the postoperative recovery of erectile function. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- IIEF-5
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 24 Feb 2022to 1 Oct 2022
- 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 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men above 18 years old wih clinically localized prostate cancer, who have undergone open or laparoscopic radical prostatectomy
Who may be able to join
- Men above 18 years old wih clinically localized prostate cancer, who have undergone open or laparoscopic radical prostatectomy, with or without use of phosphoodiesterase-5 inhibitors
Who cannot join
- Penile anatomic defects
- Uncontrolled major medical illnesses such as uncontrolled diabetes, severe renal, hepatic or cardiovascular disease
- major psychiatrics disorders
- drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University of Patras
Pátrai, Achaia, 26504
Ionanthi Kapatou, 00302613603385, kapatou_ion@hotmail.com
Kristiana Gkeka
About this study
Official title: Recalled International Index of Erectile Function-5 Collected 3 Months Postoperatively in Assessing Preoperative Erectile Function in Patients Undergoing Radical Prostatectomy
The accurate assessment of erectile function before radical prostatectomy, using validated questionnaires like IIEF-5, is crucial to evaluate postoperative changes in erectile function, as the preoperative erectile function is a prognostic factor for the postoperative recovery of erectile function. In clinical practice, patients usually present at the urologist's office 3 months after the operation without a preoperative IIEF-5 score and at that time the doctors ask them about their preoperative erectile function. With this study, the investigators would like to evaluate the agreement between a real-time preoperative IIEF-5 and a recalled one 3 months after radical prostatectomy.
Read the detailed description
Radical prostatectomy (RP) is a widely performed procedure for patients with clinically localized prostate cancer and its most common side effects include urinary incontinence and erectile dysfunction. These two side-effects become progressively more important to health-related quality of life (HRQOL) and thus the balance between cancer control and preservation of HRQOL is challenging. The postoperative changes in erectile function are directly related with the preoperative erectile function status of the patient. The most accurate evaluation of the pretreatment erectile function is the International Index of Erectile Function-5 questionnaire. The fact that in some cases the preoperative questionnaire results are negatively affected by several factors, indicates the necessity of the assessment of the degree of agreement between real time IIEF-5 scores and retrospective IIEF-5 scores after radical prostatectomy. Frequently the andrologists do not have a preoperative IIEF-5 score in their hands and this might happen for various reasons. The main reason is that urologists ask about the preoperative erectile function often with just a simple question. They rarely use a questionnaire mainly due to time constraints. According to the experience at the Sexual Rehabilitation Clinic of the University's General Hospital of Patras, 3 months is the usual time point when most patients come to the clinic after radical prostatectomy. In the first two months after surgery, patients are interested primarily in the oncological and continence issues and later they seek help for their erectile dysfunction.
- Being tested
- IIEF-5
- Keywords
- Erectile dysfunction, Prostate cancer, IIEF-5, Radical prostatectomy
- Medical subject headings
- Erectile Dysfunction, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IIEF-5Diagnostic test
The participants will be asked to complete a validated IIEF-5 questionnaire, an abridged version of the IIEF. The IIEF is a validated, brief and reliable self-administered questionnaire for assessing erectile function. Moreover, this tool is easily administered in clinical setting and demonstrates adequate sensitivity and specificity for detecting treatment-related changes in erectile function in patients with erectile dysfunction (ED).According to Rosen et al the abridged five-item version of the 15-item IIEF possesses favorable properties for detecting the presence and severity of ED for the preceding 6 months. The IIEF-5 consists of five questions, each of which is scored on a five-point ordinal scale and ED may be classified into five categories based on the calculated scores.
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of recalled International Index of Erectile Function-5
Score of recalled IIEF-5 collected 3 months after radical prostatectomy. The IIEF is a validated, brief and reliable self-administered questionnaire for assessing erectile function. The abridged five-item version of the 15-item IIEF possesses favorable properties for detecting the presence and severity of erectile dysfunction for the preceding 6 months. The IIEF-5 consists of five questions, each of which is scored on a five-point ordinal scale and erectile dysfunction may be classified into five categories based on the calculated scores. Based on IIEF-5 scores, erectile dysfunction severity is classified into the following five categories: severe (5±7), moderate (8±11), mild to moderate (12±16), mild (17±21), and no erectile dysfunction (22± 25).
Measured: 3 months
Assessment of the degree of agreement between real time preoperative International Index of Erectile Function-5 score and recalled IIEF-5 3 months after radical prostatectomy
Assessment of the degree of agreement between real time preoperative IIEF-5 score and recalled IIEF-5 3 months after radical prostatectomy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start24 Feb 2022
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stavros Kontogiannis, University Hospital of Patras
- Investigators
- Stavros Kontogiannis, Study director, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272995
- Sponsor's protocol ID
- 114/21-02-2022
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recalled International Index of Erectile Function-5 Collected 3 Months Postoperatively in Assessing Preoperative Erectile Function in Patients Undergoing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT05272995
- Acronym / sponsor ID
- 114/21-02-2022
- Keywords
- Erectile dysfunction, Prostate cancer, IIEF-5, Radical prostatectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 10 Mar 2022 (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 accurate assessment of erectile function before radical prostatectomy, using validated questionnaires like IIEF-5, is crucial to evaluate postoperative changes in erectile function, as the preoperative erectile function is a prognostic factor for the postoperative recovery of erectile function. In clinical practice, patients usually present at the urologist's office 3 months after the operation without a preoperative IIEF-5 score and at that time the doctors ask them about their preoperative erectile function. With this study, the investigators would like to evaluate the agreement between a real-time preoperative IIEF-5 and a recalled one 3 months after radical prostatectomy.
Detailed description
Radical prostatectomy (RP) is a widely performed procedure for patients with clinically localized prostate cancer and its most common side effects include urinary incontinence and erectile dysfunction. These two side-effects become progressively more important to health-related quality of life (HRQOL) and thus the balance between cancer control and preservation of HRQOL is challenging. The postoperative changes in erectile function are directly related with the preoperative erectile function status of the patient. The most accurate evaluation of the pretreatment erectile function is the International Index of Erectile Function-5 questionnaire. The fact that in some cases the preoperative questionnaire results are negatively affected by several factors, indicates the necessity of the assessment of the degree of agreement between real time IIEF-5 scores and retrospective IIEF-5 scores after radical prostatectomy. Frequently the andrologists do not have a preoperative IIEF-5 score in their hands and this might happen for various reasons. The main reason is that urologists ask about the preoperative erectile function often with just a simple question. They rarely use a questionnaire mainly due to time constraints. According to the experience at the Sexual Rehabilitation Clinic of the University's General Hospital of Patras, 3 months is the usual time point when most patients come to the clinic after radical prostatectomy. In the first two months after surgery, patients are interested primarily in the oncological and continence issues and later they seek help for their erectile dysfunction.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men above 18 years old wih clinically localized prostate cancer, who have undergone open or laparoscopic radical prostatectomy
Key inclusion criteria (1 listed)
- Men above 18 years old wih clinically localized prostate cancer, who have undergone open or laparoscopic radical prostatectomy, with or without use of phosphoodiesterase-5 inhibitors
Key exclusion criteria (4 listed)
- Penile anatomic defects
- Uncontrolled major medical illnesses such as uncontrolled diabetes, severe renal, hepatic or cardiovascular disease
- major psychiatrics disorders
- drug or alcohol abuse
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 |
|---|---|---|
| IIEF-5The participants will be asked to complete a validated IIEF-5 questionnaire, an abridged version of the IIEF. The IIEF is a validated, brief and reliable self-administered questionnaire for assessing erectile function. Moreover, this tool is easily administered in clinical setting and demonstrates adequate sensitivity and specificity for detecting treatment-related changes in erectile function in patients with erectile dysfunction (ED).According to Rosen et al the abridged five-item version of the 15-item IIEF possesses favorable properties for detecting the presence and severity of ED for the preceding 6 months. The IIEF-5 consists of five questions, each of which is scored on a five-point ordinal scale and ED may be classified into five categories based on the calculated scores. | Diagnostic test | – |
Primary outcome
Score of recalled International Index of Erectile Function-5
Time frame: 3 months
Score of recalled IIEF-5 collected 3 months after radical prostatectomy. The IIEF is a validated, brief and reliable self-administered questionnaire for assessing erectile function. The abridged five-item version of the 15-item IIEF possesses favorable properties for detecting the presence and severity of erectile dysfunction for the preceding 6 months. The IIEF-5 consists of five questions, each of which is scored on a five-point ordinal scale and erectile dysfunction may be classified into five categories based on the calculated scores. Based on IIEF-5 scores, erectile dysfunction severity is classified into the following five categories: severe (5±7), moderate (8±11), mild to moderate (12±16), mild (17±21), and no erectile dysfunction (22± 25).
Assessment of the degree of agreement between real time preoperative International Index of Erectile Function-5 score and recalled IIEF-5 3 months after radical prostatectomy
Time frame: 3 months
Assessment of the degree of agreement between real time preoperative IIEF-5 score and recalled IIEF-5 3 months after radical prostatectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
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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.
Stavros Kontogiannis study director
University of Patras
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 Erectile Dysfunction Following Radical Prostatectomy, run by University Hospital of Patras at 1 site in Greece.
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 4 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: status not confirmed, as of the sponsor's last update on 25 Mar 2022. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stavros Kontogiannis (00306974678699, stavroskontogiannis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of recalled International Index of Erectile Function-5 (time frame: 3 months). The study lists 2 primary outcomes in all. 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 25 Mar 2022.