Electrophysiologic Mapping of the Bladder
Pilot of Electrophysiologic Mapping of the Urinary Bladder
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This pilot study is looking at the possibility of adapting some of the tools and techniques used by cardiac electrophysiologists (doctors specializing in the electrical activity of the heart) to help diagnose and treat Overactive Bladder. The rationale for this approach is based on the similarities of the two organs. In simple terms, the heart and bladder are both hollow muscular organs that expand and contract to hold and move fluid.
In an electrophysiology study looking at cardiac (heart) arrhythmia (irregular heartbeat), the cardiologist places one or more electrode catheters (thin hollow tube with an electrical conductor on the end) through a vein or artery in the leg or arm to contact heart tissue. By recording the electrical activity at multiple sites of the heart, the catheter allows for mapping of the electrical activity and the arrhythmia mechanism.
In this study, investigators will use the same electrode catheter to contact bladder tissue, introduce a low frequency current, and map the electrical activity of the bladder. A sterile cardiac electrical mapping catheter will be used to make contact with the walls of the bladder and introduce a low frequency current starting with the trigone and then the four quadrants of the dome. Electrical activity will be recorded for each volumetric milestone at each location. It is hoped that the information from this electrophysiological testing of the bladder may eventually lead to treatment of areas of electrical abnormality of interest. No actual treatment of the bladder will be done as part of this pilot study.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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New Jersey
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Englewood, New Jersey, États-Unis, 07631
- Englewood Hospital and Medical Center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Subject is a female > = 18 years old.
- Subject is willing and able to provide informed consent.
- Subject has subjective and objective evidence for urinary urgency (with or without incontinence), stress incontinence, or mixed incontinence (with features of both urgency and stress).
- Subject requires urodynamic/cystoscopic studies to complete their workup.
Exclusion Criteria:
- Active urinary tract infection
- Pregnant women
- Patients on anticholinergic medicine for overactive bladder
- Patients with history of intravesical botulinum toxin injections
- Patients with a sacral neuromodulator implant
- Patients with a history of urinary tract malignancy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: All subjects
Electrical mapping of the urinary bladder
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in electrical activity
Délai: 3 months
|
goal of this pilot study is to determine whether electrical activity can be recorded from different areas of the bladder using cardiac surface electrodes
|
3 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Michael Vardy, MD, Englewood Hospital and Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- E-13-529
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