An Exploratory Study to Investigate Bladder Contractions in the Storage Phase and Related Bladder Sensations in Healthy Females and Females With Overactive Bladder (OAB) Using High Resolution and Conventional Urodynamics
14 octobre 2014 mis à jour par: Astellas Pharma Europe Ltd.
An Exploratory Study to Evaluate Bladder Contractions in the Storage Phase (Non Voiding Activities) and Related Bladder Sensation in Healthy Females and Untreated Females With Overactive Bladder ("OAB") Using High Resolution and Conventional Urodynamics
This study aims to identify differences in bladder contractions during the storage phase (non voiding activities) between OAB subjects and healthy subjects, using high resolution urodynamics.
The study is divided into two parts:
- PART 1: Consists of 5 females with overactive bladder
- PART 2: Consists of 25 females with overactive bladder and 15 healthy females
Part 1 subjects will be enrolled followed by part 2 subjects. The data from part 1 subjects will be reviewed and analysed by a group of experts before starting the second part (part 2) of the study.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Description détaillée
The subjects will complete a total of 2 visits and a follow up telephone call (or visit at the investigator's discretion).
Upon meeting eligibility criteria subjects will be screened and complete visit at hospital (Visit 1). They will then be asked to complete procedures such micturition diary, questionnaires and if applicable discontinued their ongoing OAB medication. Upon confirmation of eligibility criteria subjects will then be enrolled and complete visit 2 within 6 to 31 days post V1. At Visit 2 subjects will complete high resolution urodynamic assessment followed by the conventional urodynamic assessment. The visit will take approximately half a day. Safety follow up phone call (or visit at investigator's discretion) will take place 4 to 6 days post visit 2.
Type d'étude
Interventionnel
Inscription (Réel)
6
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Maastricht, Pays-Bas, 6202
- Maastricht University Medical Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
35 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
OAB Subjects
- Has history of signs and symptoms of OAB including urinary frequency, urgency or urge incontinence for greater than or equal to 3 months
At enrolment visit (V2) the subjects must have:
- At least 1 episode of urgency with or without incontinence in the last 3-day micturition diary
- Frequency of micturition greater than or equal to 8 per 24 hours period during the 3-day micturition diary period
- At the screening visit, the subject should be either naïve to OAB treatment (e.g no prior history of medications to treat lower urinary tract symptoms (LUTS), including OAB) or currently on treatment for LUTS (including OAB) and is willing to undergo a washout period for 3 weeks
Main Exclusion criteria:
Healthy subjects
- History of lower urinary tract symptoms (LUTS), including OAB
- History of stress urinary incontinence, urethral sphincter incompetence and neurogenic detrusor overactivity
- History of signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis)
- History of bladder outlet obstruction (not including detrusor-overactivity) for example bladder/vesicouterine pro-lapse (> grade II) or chronic obstruction
- History of urinary tract surgery less than or equal to 6 months prior to screening
- Has an indwelling catheter or permanent catheter fitted
- History of pelvic area radiotherapy treatment
- Uncontrolled diabetes mellitus
- History of fibromyalgia
- Pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control (note: reliable methods are contraceptive pills of combination type, hormonal implants, injectable contraceptives, sexual abstinence or vasectomized partner)
- Pregnancy within 6 months before screening or breast feeding within 3 months before screening
- History of a positive hepatitis A, B surface antigen, hepatitis C antibody or HIV test result.
- Any use of drugs of abuse within 3 months prior to screening visit.
- History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to screening visit
- History of drinking more than 14 units of alcohol per week (1 unit = 10 g pure alcohol = 250 ml of beer (5%) or 35 ml of spirits (35%) or 100 ml of wine (12%) within 3 months prior to screening visit
- Is currently receiving or has a history of treatment with alpha blockers, beta receptor blockers or agonists, botulinum toxin (less than 12 months), resiniferatoxin or pelvic floor muscle relaxants less than or equal to 9 months prior to screening
Main exclusion criteria OAB subjects
- Refer to healthy subjects exclusion criteria number 2 to 16
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Part 1: OAB subjects
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Expérimental: Part 2: Healthy subjects
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Expérimental: Part 2: OAB subjects
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Identify objective parameters to characterize Non Voiding Activity (NVA) in healthy and OAB subjects using high resolution urodynamic assessment
Délai: During the High resolution urodynamics (Day 1)
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NVA is defined as changes of pressure in the bladder lumen.
These changes are measured as detrusor pressure (Pdet) calculated from substraction of intra-abdominal pressure (Pabd) from intra-vesical pressure (Pves).
All Pdet with an amplitude of at least 1cm of water, frequency below 0.2 Hz and pulse duration between 5 and 60 seconds qualify as NVA.
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During the High resolution urodynamics (Day 1)
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Identify NVA in healthy and OAB subjects using conventional urodynamic assessment
Délai: During High resolution and conventional urodynamic (Day 1) assessments
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During High resolution and conventional urodynamic (Day 1) assessments
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Assess the subjects bladder sensations measured by visual analogue scale (VAS) and 5-points categorical scale (Appendix 8 & 7) during the high resolution urodynamic and conventional assessments
Délai: During High resolution and conventional urodynamic assessments (Day 1)
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During High resolution and conventional urodynamic assessments (Day 1)
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Assess the correlation between NVA and subjects bladder sensations
Délai: During High resolution and conventional urodynamic assessments (Day 1)
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During High resolution and conventional urodynamic assessments (Day 1)
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Explore NVA in a subgroup of subjects defined by the severity of OAB symptoms collected as background information (3-days bladder diary)
Délai: During High resolution and conventional urodynamic assessments (Day 1)
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During High resolution and conventional urodynamic assessments (Day 1)
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Illustrate the amount of NVA detected with high resolution urodynamic test methodology compared to NVA detected with conventional urodynamic assessments
Délai: During High resolution and conventional urodynamic assessments (Day 1)
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During High resolution and conventional urodynamic assessments (Day 1)
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Assess symptoms severity, bother and its impact on quality of life using: OAB-Q short form and Urogenital Distress Inventory (UDI-6) questionnaires and a 3-Day micturition bladder diary as background information to characterize the study population
Délai: During High resolution and conventional urodynamic assessments (Day 1)
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During High resolution and conventional urodynamic assessments (Day 1)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Clinical Study Manager, Astellas Pharma Europe Ltd.
- Chercheur principal: Principal Investigator, Maastricht University Medical Center, Maastricht
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2012
Achèvement primaire (Réel)
1 juin 2012
Achèvement de l'étude (Réel)
1 juin 2012
Dates d'inscription aux études
Première soumission
13 février 2012
Première soumission répondant aux critères de contrôle qualité
23 février 2012
Première publication (Estimation)
29 février 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
15 octobre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 octobre 2014
Dernière vérification
1 octobre 2014
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 905-EC-010
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