Erectile DysfunctionMENDiPNCT05578157
MENDiP: Measurements of Overnight Penile Temperature to Evaluate Nocturnal Erection Detection in Patients With Absence of Erectile Functioning After Robot-assisted Radical Prostatectomy
An observational study of Erectile Dysfunction and Erectile Dysfunction Following Radical Prostatectomy, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation. The Staying Hot and Feeling Hot study have shown that nocturnal erection detection is feasible with patient-friendly overnight penile temperature measurements. Read more about this study
- Who is it for?
- Ages 55 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction, Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Feeling Hot sensor
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jan 2023to 10 Oct 2023
- 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 55 to 70 years
- Men only
- Adult, Older adult
Study population: Fifteen patients, aged 55 - 70 years, who will undergo a non- or unilateral-nerve-sparing robot assisted radical prostatectomy will be included in case preoperative normal erectile functioning and postoperative complete impotence at three months after surgery.
Who may be able to join
- Preoperative measurement:
- Aged 55 - 70 years
- Prostatecancer patients undergoing a non-/unilateral-nerve-sparing radical prostatectomy (RARP)
- Pre-operative IIEF-5 score > 21
- Postoperative measurement
- Preoperative penile temperature increase during first nocturnal erection of minimally 0.4 degrees Celsius
- Post-operative IIEF-5 score < 12 with absence of morning erections
Who cannot join
- Test subjects who are unwilling to sign informed consent
- Test subjects with erectile dysfunction before RARP (IIEF-5 score of below 22)
- (History of) sickle cell aneamia, atherosclerosis and diabetes type I or II. These conditions might influence penile blood circulation and therefore the accuracy of the study outcomes.
- (History of) REM-sleep behavior disorder or other sleep disorders such as restless legs syndrome, insomnia, and sleep apnea
- Usage of sleeping pills or benzodiazepines.
- Postoperative results will be excluded from the study in case of presence of nocturnal erections according to the RigiScan data.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, 3435CM
Hille Torenvlied, MSc, +31883202500, h.torenvlied@antoniusziekenhuis.nl
Karlijn van Adrichem, BSc.
About this study
Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation. The Staying Hot and Feeling Hot study have shown that nocturnal erection detection is feasible with patient-friendly overnight penile temperature measurements. The question has arisen whether the penile temperature methodology is also capable to detect the absence of nocturnal erections, which is essential for clinical implementation in erectile dysfunction diagnostics. The objective of the MENDiP-study is to determine the feasibility to detect the absence of nocturnal erections with overnight penile temperature sensors. Furthermore, the MENDiP study functions as a first pilot trial to investigate the effect of age on the penile temperature during nocturnal erections in test subjects with normal erectile functioning. This is done in an observational study with a longitudinal design in which pre- and postoperative ambulatory overnight measurements are performed in patients, aged 55 - 70 years with preoperative normal sexual functioning, undergoing a non- or unilateral nerve-sparing robot assisted radical prostatectomy.
- Being tested
- Feeling Hot sensor
- Keywords
- Erectile Dysfunction, Nocturnal erection, RigiScan, Penile temperature
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeling Hot sensorDiagnostic test
The Feeling Hot sensor is a proof-of-concept system, which can measure overnight penile, thigh and air temperature.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Age 55 - 60 years Receives: Diagnostic Test: Feeling Hot sensor | |
| Group 2 | Age 60 - 65 years Receives: Diagnostic Test: Feeling Hot sensor | |
| Group 3 | Age 65 - 70 years Receives: Diagnostic Test: Feeling Hot sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detectability absence nocturnal erections
Visual detectability of the presence and absence of nocturnal erections in overnight penile temperature measurements
Measured: 9 hours
Penile temperature REM-sleep
Maximal variation in penile temperature during REM-sleep in case of presence and absence of nocturnal erections
Measured: 9 hours
Penile temperature nocturnal erection
Maximal variation in penile temperature during nocturnal erections in men aged 55 - 70 years
Measured: 9 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start18 Jan 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion10 Oct 2023 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hille Torenvlied, St. Antonius Hospital
- Investigators
- Jack Beck, dr., MD, Principal investigator, Urologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578157
- Sponsor's protocol ID
- ABR: 82813
- Acronym
- MENDiP
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MENDiP: Measurements of Overnight Penile Temperature to Evaluate Nocturnal Erection Detection in Patients With Absence of Erectile Functioning After Robot-assisted Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT05578157
- Acronym / sponsor ID
- MENDiP / ABR: 82813
- Keywords
- Erectile Dysfunction, Nocturnal erection, RigiScan, Penile temperature
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 18 Jan 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 10 Oct 2023 (estimated)
- First posted
- 13 Oct 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.
Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation. The Staying Hot and Feeling Hot study have shown that nocturnal erection detection is feasible with patient-friendly overnight penile temperature measurements. The question has arisen whether the penile temperature methodology is also capable to detect the absence of nocturnal erections, which is essential for clinical implementation in erectile dysfunction diagnostics. The objective of the MENDiP-study is to determine the feasibility to detect the absence of nocturnal erections with overnight penile temperature sensors. Furthermore, the MENDiP study functions as a first pilot trial to investigate the effect of age on the penile temperature during nocturnal erections in test subjects with normal erectile functioning. This is done in an observational study with a longitudinal design in which pre- and postoperative ambulatory overnight measurements are performed in patients, aged 55 - 70 years with preoperative normal sexual functioning, undergoing a non- or unilateral nerve-sparing robot assisted radical prostatectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Feeling Hot sensorAge 55 - 60 years |
| Group 2 | – | Diagnostic Test: Feeling Hot sensorAge 60 - 65 years |
| Group 3 | – | Diagnostic Test: Feeling Hot sensorAge 65 - 70 years |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Fifteen patients, aged 55 - 70 years, who will undergo a non- or unilateral-nerve-sparing robot assisted radical prostatectomy will be included in case preoperative normal erectile functioning and postoperative complete impotence at three months after surgery.
Key inclusion criteria (7 listed)
- Preoperative measurement:
- Postoperative measurement
Key exclusion criteria (6 listed)
- Test subjects who are unwilling to sign informed consent
- Test subjects with erectile dysfunction before RARP (IIEF-5 score of below 22)
- (History of) sickle cell aneamia, atherosclerosis and diabetes type I or II. These conditions might influence penile blood circulation and therefore the accuracy of the study outcomes.
- (History of) REM-sleep behavior disorder or other sleep disorders such as restless legs syndrome, insomnia, and sleep apnea
- Usage of sleeping pills or benzodiazepines.
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 |
|---|---|---|
| Feeling Hot sensorThe Feeling Hot sensor is a proof-of-concept system, which can measure overnight penile, thigh and air temperature. | Diagnostic test | Group 1, Group 2, Group 3 |
Primary outcome
Detectability absence nocturnal erections
Time frame: 9 hours
Visual detectability of the presence and absence of nocturnal erections in overnight penile temperature measurements
Penile temperature REM-sleep
Time frame: 9 hours
Maximal variation in penile temperature during REM-sleep in case of presence and absence of nocturnal erections
Penile temperature nocturnal erection
Time frame: 9 hours
Maximal variation in penile temperature during nocturnal erections in men aged 55 - 70 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Erectile Dysfunction
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruiting
Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
Prostate Cancer, Localized Prostate Carcinoma
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
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.
Jack Beck, dr., MD principal investigator
Urologist
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 and Erectile Dysfunction Following Radical Prostatectomy, run by St. Antonius Hospital at 1 site in Netherlands.
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 7 inclusion and 6 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 13 Oct 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 Netherlands. 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 Hille Torenvlied, MSc. (+31883202500, h.torenvlied@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detectability absence nocturnal erections (time frame: 9 hours). The study lists 3 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 13 Oct 2022.