Basic Sensations Coming From the Bladder
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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 |
- 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 |
Healthy volunteers
Patients with overactive bladder
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| Netherlands | |
| Maastricht University Medical Centre | |
| Maastricht, Netherlands, 6202 AZ | |
| 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 Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013