MENDiP: Measurements of Overnight Penile Temperature to Evaluate Nocturnal Erection Detection in Patients With Absence of Erectile Functioning After Robot-assisted Radical Prostatectomy

NCT05578157 | Unknown DMC

• 1 other identifier: ABR: 82813
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation.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. 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.

Conditions

Erectile Dysfunction; Erectile Dysfunction Following Radical Prostatectomy

Keywords

Erectile Dysfunction; Nocturnal erection; RigiScan; Penile temperature

Outcome Measures

Primary Outcomes (3)

• Detectability absence nocturnal erections

  Visual detectability of the presence and absence of nocturnal erections in overnight penile temperature measurements

  9 hours

• Penile temperature REM-sleep

  Maximal variation in penile temperature during REM-sleep in case of presence and absence of nocturnal erections

  9 hours

• Penile temperature nocturnal erection

  Maximal variation in penile temperature during nocturnal erections in men aged 55 - 70 years

  9 hours

Other Outcomes (1)

• Demographic data

  1 year

Study Arms (3)

Group 1

Age 55 - 60 years

Diagnostic Test: Feeling Hot sensor

Group 2

Age 60 - 65 years

Diagnostic Test: Feeling Hot sensor

Group 3

Age 65 - 70 years

Diagnostic Test: Feeling Hot sensor

Interventions

Feeling Hot sensor DIAGNOSTIC_TEST

The Feeling Hot sensor is a proof-of-concept system, which can measure overnight penile, thigh and air temperature.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (1)

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3435CM, Netherlands

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Jack Beck, dr., MD

  Urologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hille Torenvlied, MSc.

CONTACT

+31883202500; h.torenvlied@antoniusziekenhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc.

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: January 18, 2023
• Primary Completion: June 30, 2023
• Study Completion: October 10, 2023
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)