Basic Sensations Coming From the Bladder

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01114412
First received: April 29, 2010
Last updated: April 30, 2010
Last verified: April 2010
  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 [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 29, 2010
Last Updated: April 30, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on September 16, 2014