We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Basic Sensations Coming From the Bladder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01114412
First Posted: May 3, 2010
Last Update Posted: May 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maastricht University Medical Center
  Purpose

A major complication in studies to identify the nature of bladder sensations is language. It is difficult, if not near impossible, for the lay person, with no knowledge of physiology, anatomy or pathology, to put into simple terms a description of basic visceral sensations. Therefore, before the investigators can speculate about the detailed mechanisms generating sensation the investigators must overcome this language and communication difficulty. This will be addressed in the present study.

There are important reasons why the investigators must identify the mechanisms generating the different sensations as the bladder fills. One of them is that these are basic physiological mechanisms which need to be better understood.


Condition
Healthy Overactive Bladder Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Description of Basic Visceral Sensations Coming From the Bladder

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • description of bladder sensations

    The primary objective of this experiment is to address how medical students and patients with OAB describe the sensations they feel during the filling phase of the bladder.

    Primary objectives

    • To put into simple terms a description of basic visceral sensations coming from the bladder
    • Describe the pattern of normal sensations during filling


Enrollment: 11
Study Start Date: September 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients
Patients with overactive bladder syndrome
Healthy volunteers
Healthy volunteers

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy volunteers

Patients with overactive bladder

Criteria

Inclusion Criteria:

Healthy volunteers

  • Healthy students from The University of Maastricht well versed in Dutch.

Patients

  • Patients with OAB diagnosed by their urologist using the criteria of more than 8 micturitions on three consecutive days. Before the start of any anticholinergic or other therapy. Patients on anticholinergic therapy will be asked to stop this therapy for at least 10 days before they enter the first session.
  • Well versed in Dutch.

Exclusion Criteria:

Healthy volunteers

  • Use of any medication (except oral contraceptives)
  • Surgical history of the abdomen
  • Urinary complaints (e.g. frequency, urgency)
  • Urinary tract infection

Patients:

  • Congestive heart disease or history of heart failure
  • Presence of urinary tract infection. These patients will be treated by antibiotics.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114412


Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Director: Gommert A van Koeveringe, MD, PhD, Urologist Maastricht University Medical Centre
  More Information

Responsible Party: G.A. van Koeveringe (MD, PhD, Urologist), Maastricht University Medical Centre
ClinicalTrials.gov Identifier: NCT01114412     History of Changes
Other Study ID Numbers: 09-4-045.8
First Submitted: April 29, 2010
First Posted: May 3, 2010
Last Update Posted: May 3, 2010
Last Verified: April 2010

Keywords provided by Maastricht University Medical Center:
focus groups
overactive bladder
bladder sensations

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms