- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00971646
Cohort Study: Perceptual Urge Sensation
Over the past few years it has become clear that our understanding of bladder physiology is inadequate to explain urge incontinence. This has forced us to re-evaluate what we know and do not know about bladder function and dysfunction. This has led to the identification and study of novel systems within the bladder that may contribute to abnormal sensations.
The investigators now suspect that the organic changes occurring in the bladder are not the whole story. For one group of patients with pathological urge there is growing evidence suggesting that there may be a strong psychological component. The idea now being put forward is that normal afferent peripheral information is perceived as abnormal and excessive, resulting in an increased desire to go to the bathroom: 'perceptual urge'. It is important to identify this group of patients since it will direct their treatment towards more cognitive approaches. Also, if such a psychological aetiology can be eliminated it would lead to a more focused and effective management of peripheral pathology with surgery or pharmacology.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Limburg
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Maastricht, Limburg, Olanda, 6202 AZ
- Maastricht University Medical Centre
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
The study population consists of two groups: 1: patients with OAB; 2: patients with osteoporosis.
The patients with OAB will be reqruited from the outpatient clinic and website designed for patients with overactive bladder symptoms.
The patients with osteoporosis will be recruited from an electronic patient database.
Descrizione
Inclusion Criteria (for patients with OAB):
- Patients older than 18 years with OAB diagnosed by their urologist using the criteria of more than 8 micturitions on three consecutive days of these three days they keep a micturation diary with a VAS score for urge sensation.
Patients should have at least one episode of urge: sudden compelling desire to void which can not be postponed.
- Well versed in Dutch.
Inclusion Criteria (for patients with osteoporosis):
- Patients older than 18 years with osteoporosis joined into the Fast Guide cohort program.
- Well versed in Dutch.
Exclusion Criteria (for patients with OAB):
- Patients with stress-urinary incontinence
- Presence of post void residual urine > 100cc determined by ultrasound
- Presence of urinary tract infection, determined by urine sticks. Patients with urinary tract infection will be treated by antibiotics. After resolution of the infection, the patient can re-enter the study if the urine is sterile at that moment.
Exclusion Criteria (for patients with osteoporosis):
- Urinary complaints or urologic history
- Presence of postvoid residual urine > 100cc determined by ultrasound
- Presence of urinary tract infection, determined by urine sticks. Patients that present with urinary tract infection will be definitively excluded from participation.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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OAB
Patients with overactive bladder syndrome
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On the micturition diary patients are asked to note every void and drink.
With every void they are asked to estimate their bladder volume and grade their degree of desire to void.
This questionnaire is designed to screen for the presence of a mood disorder.
This questionnaire grades the health condition of the subject.
The questions tap cognitive, emotional, and physical appearance aspects of directing their attention to the self.
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Osteoporosis
Patients with osteoporosis
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On the micturition diary patients are asked to note every void and drink.
With every void they are asked to estimate their bladder volume and grade their degree of desire to void.
This questionnaire is designed to screen for the presence of a mood disorder.
This questionnaire grades the health condition of the subject.
The questions tap cognitive, emotional, and physical appearance aspects of directing their attention to the self.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Defining differences in self-consciousness and HADS scores in patients with OAB
Lasso di tempo: 1 year
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1 year
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Defining differences between self-consciousness and HADS scores between the two cohorts
Lasso di tempo: 1 year
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1 year
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Defining differences in quality of life between the two cohorts
Lasso di tempo: 1 year
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1 year
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Collaboratori e investigatori
Investigatori
- Direttore dello studio: Gommert van Koeveringe, MD, PhD, urologist, Maastricht University Medical Centre
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 09-1234567
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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