Trials / Unknown
UnknownNCT05578157
MENDiP: Measurements of Overnight Penile Temperature to Evaluate Nocturnal Erection Detection in Patients With Absence of Erectile Functioning After Robot-assisted Radical Prostatectomy
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 15 (estimated)
- Sponsor
- St. Antonius Hospital · Academic / Other
- Sex
- Male
- Age
- 55 Years – 70 Years
- Healthy volunteers
- —
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Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation.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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Feeling Hot sensor | The Feeling Hot sensor is a proof-of-concept system, which can measure overnight penile, thigh and air temperature. |
Timeline
- Start date
- 2023-01-18
- Primary completion
- 2023-06-30
- Completion
- 2023-10-10
- First posted
- 2022-10-13
- Last updated
- 2022-10-13
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05578157. Inclusion in this directory is not an endorsement.