Trial Radar KI | ||
|---|---|---|
Die klinische Studie NCT07283484 (RELIEF) für Acute Urinary Retention, Benign Prostate Obstruction, Benign Prostate Hyperplasia, Benign Prostate Hypertrophy(BPH) ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention. (RELIEF) 478 Randomisiert
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07283484 (RELIEF) ist eine interventionsstudie zur Untersuchung von Acute Urinary Retention, Benign Prostate Obstruction, Benign Prostate Hyperplasia, Benign Prostate Hypertrophy(BPH) und hat den Status offene rekrutierung. Die Studie startete am 21. August 2025 und soll 478 Teilnehmer aufnehmen. Durchgeführt von Liselot Ribbert ist der Abschluss für 1. März 2029 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 22. Dezember 2025 aktualisiert.
Kurzbeschreibung
Acute urinary retention (AUR) is a sudden and painful condition. It occurs when a person is unable to urinate. In men, AUR is most often caused by an enlarged prostate, known as benign prostatic hyperplasia (BPH), which blocks the urethra. The first steps in treatment are to insert a catheter to empty the bladder and to start medication that acts on the prostate (an alpha-blocker). After some time, the catheter is re...Mehr anzeigen
Ausführliche Beschreibung
not aplicable
Offizieller Titel
Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention: a Randomized Controlled Trial (the RELIEF Study).
Erkrankungen
Acute Urinary RetentionBenign Prostate ObstructionBenign Prostate HyperplasiaBenign Prostate Hypertrophy(BPH)Weitere Studien-IDs
- RELIEF
- NL-009284
- 10390032310057 (Andere Zuwendungs-/Finanzierungsnummer) (ZonMw)
NCT-Nummer
Studienbeginn (tatsächlich)
2025-08-21
Zuletzt aktualisiert
2025-12-22
Studienende (vorauss.)
2029-03-01
Geplante Rekrutierung
478
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
RELIEF
Acute Urinary Retention
Urinary Retention
TWOC
Trial Without Catheter
bladder catheter
urinary catheter
catheter removal
catheter withdrawal
Benign prostate obstruction
BPO
Benign prostate hyperplasia
BPH
Acute Urinary Retention
Urinary Retention
TWOC
Trial Without Catheter
bladder catheter
urinary catheter
catheter removal
catheter withdrawal
Benign prostate obstruction
BPO
Benign prostate hyperplasia
BPH
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellTWOC after 3 days | TWOC after 3 days A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization. |
Aktives VergleichspräparatTWOC after 14 days | TWOC after 14 days A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Re-catheterization rate after TWOC. | Either 3 or 14 days after catheterization, depending on study group allocation. |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Patient reported outcomes - IPSS | Lower urinary tract symptoms measured by the International Prostate Symptom Score (IPSS).
IPSS is a self-reported score assessing urinary symptoms, including voiding and storage symptoms.
Range: 0 to 35 (higher scores indicate more severe symptoms). | Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months. |
Patient reported outcomes - EQ-5D-5L | General health-related quality of life measured by the EuroQol 5 Dimensions, 5 Levels questionnaire (EQ-5D-5L) EQ-5D-5L assesses health status across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Range: 0 to 1 for the index score (higher scores indicate better health); Visual Analogue Scale (VAS) range: 0 to 100 (higher scores indicate better health). | Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months. |
Patient reported outcomes - ICIQ-LTCqol | Catheter-related symptoms and concerns measured by the International Consultation on Incontinence Questionnaire - Long-Term Catheter Quality of Life (ICIQ-LTCQoL) ICIQ-LTCQoL assesses the impact of long-term catheter use on quality of life, including symptoms and concerns.
Range: 0 to 21 (higher scores indicate more concern and poorer quality of life). | Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months. |
Process related outcomes - Catheter-related complications | Catheter related complications (e.g., macroscopic hematuria, CAUTI, urosepsis, catheter related pain or other catheter related problems, urethral strictures), assessed through medical record review and telephone evaluation. | Up to 18 months after catheter insertion. |
Resource related outcomes - Health care costs | Direct health care costs, including costs of (re)catheterization, diagnosis and treatment of complications, and hospital admissions, assessed through medical record review and the iMTA Medical Consumption Questionnaire (iMCQ). | Up to 6 months after catheter insertion (iMCQ assessed at 3 and 6 months). |
Resource related outcomes - Productivity losses | Productivity losses (social costs) assessed using the iMTA Productivity Cost Questionnaire (iPCQ). | Up to 6 months after catheter insertion (iPCQ assessed at 1, 2, 3, and 6 months). |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Männlich
- Adult men (≥18 years)
- Diagnosis of acute urinary retention (AUR) treated with a transurethral catheter (TUC) and alpha-blocker therapy (tamsulosin, silodosin, or alfuzosin)
- Mentally competent and able to understand the potential benefits and burdens of study participation
- Provision of written or digital informed consent
- Failed prior TWOC within the preceding 30 days
- Initial urinary retention volume >1500 mL
- Neurogenic bladder dysfunction (e.g., multiple sclerosis, spinal cord injury, spina bifida)
- History of prostate cancer with ISUP grade group ≥2
- History of active bladder cancer or ongoing surveillance for bladder cancer
- Urinary retention occurring within 72 hours after surgery (postoperative urinary retention)
- History of lower urinary tract surgery (e.g., bladder augmentation, urethral surgery, or prostate surgery)
- AUR suspected to be caused by bladder stones
- Suspected urethral stricture, clot retention, or urosepsis
- Contraindication to alpha-blocker therapy
Liselot Ribbert- 🏥Alrijne Hospital
Verantwortliche Partei
Liselot Ribbert, Prüfsponsor, Study Director, Isala
Zentrale Studienkontakte
Kontakt: Liselot L.A. Ribbert, MD,. PhD candidate, +31653182448, [email protected]
Kontakt: Bart P.W. Witte, MD, PhD, +31886244357, [email protected]
11 Studienstandorte in 1 Ländern
Gelderland
St. Jansdal, Harderwijk, Gelderland, 3844 DG, Netherlands
Celine ten Donkelaar, MD, PhD, Kontakt, +31341463558, [email protected]
Noch nicht rekrutierend
Canisius Wilhelmina Hospital, Nijmegen, Gelderland, 6532SZ, Netherlands
Diederick Duijvesz, MD, PhD, Kontakt, [email protected], [email protected]
Offene Rekrutierung
Limburg
Zuyderland Ziekenhuis, Heerlen, Limburg, 6419 PC, Netherlands
Kevin Rademakers, MD, PhD, Kontakt, +31884599704
Noch nicht rekrutierend
Maastricht University Medical Center+, Maastricht, Limburg, 6229 HX, Netherlands
John Heesakkers, MD, PhD, Kontakt, +31433877400, [email protected]
Offene Rekrutierung
North Brabant
Catharina Hospital, Eindhoven, North Brabant, 5623 EJ, Netherlands
Evert Koldewijn, MD, PhD, Kontakt, +31402397040, [email protected]
Offene Rekrutierung
North Holland
OLVG, Amsterdam, North Holland, 1091 AC, Netherlands
Ernst van Haarst, MD, PhD, Kontakt, +31205108694, [email protected]
Offene Rekrutierung
Spaarne Gasthuis, Hoofddorp, North Holland, 2134 TM, Netherlands
Lieke Gietelink, MD, PhD, Kontakt, +31232240160, [email protected]
Noch nicht rekrutierend
Overijssel
Ziekenhuisgroep Twente, Hengelo, Overijssel, 7555 DL, Netherlands
Christa van der Fels, MD, PhD, Kontakt, +31887083390, [email protected]
Noch nicht rekrutierend
Isala, Zwolle, Overijssel, 8025AB, Netherlands
Liselot L.A. Ribbert, MD, PhD candidate, Kontakt, +31653182448, [email protected]
Offene Rekrutierung
Provincie Groningen
Martini Hospital, Groningen, Provincie Groningen, 9728NT, Netherlands
Jaap Poerink, MD, Kontakt, 0505245245, [email protected]
Offene Rekrutierung
South Holland
Alrijne Hospital, Leiderdorp, South Holland, 2353 GA, Netherlands
Barbara Schout, MD, PhD, Kontakt, +31715828060, [email protected]
Offene Rekrutierung