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Sponsored by: |
Maastricht University Medical Center |
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Information provided by: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT00628615 |
Rationale:
The sensation of the need for urination (urge) is a complex and only partially understood mechanism. It is our hypothesis that this mechanism is disrupted in patients suffering from overactive bladder syndrome. The Overactive Bladder syndrome (OAB) has been defined as a spectrum of symptoms in which incontinence may or may not overlap with urgency, frequency and nocturia. This syndrome is estimated to affect approximately 17% of the adult population in Europe and the United States. The symptoms of overactive bladder have many potential causes and contributing factors. One of these factors is an outlet obstruction of the bladder due to benign prostatic hyperplasia (BPH). Nowadays antimuscarinic drugs are used for treatment of the overactive bladder. Antimuscarinic agents have been proven to work slightly to moderately better than placebo's and are associated with side effects such as a dry mouth, blurred vision and constipation.
Many patients with lower urinary tract symptoms (LUTS) develop OAB. In this group of patients with LUTS and OAB, there is not always a clear obstruction found. So, at least in some patients, with LUTS, there must be another reason for OAB than obstruction.
The autonomous bladder activity has been introduced by, among others the Maastricht Urology research group. In animal models, the bladder is shown to have rhythmic low amplitude contractions (micro motions). It is hypothesized that this activity has a sensory function in the micturation regulation system which is mainly located in the bladder wall. These so called micromotions have never been demonstrated in the human bladder. The sensing function of the bladder and the micturation reflex remain mainly unclear. We hypothesise that there is a disregulation of the autonomous bladder activity (micro motions) in patients with OAB. We want to explore and study the relationship between OAB, obstruction and the micro motions in order to gain a better understanding of the bladder (patho)physiology. reason for This on its turn, can help us in the quest for better treatment strategies for patients suffering from OAB.
Objective:
The study is divided in two distinct groups a male and female group:
The male group consist of patients with lower urinary tract symptoms (LUTS). The female group consist of patients with the overactive bladder syndrome OAB.
The primary objective of this pilot experiment is to describe via an observational study the relation between non-micturation bladder activity and sensation during the filling phase of the bladders in women. We want to explore if there is a relation between non-micturation bladder activity and the sensation of urgency during the filling phase. Furthermore in men, we want to study the relationship between non-micturation bladder activity and the amount of obstruction.
We would also like to visualize the micro motions of the bladder in both men and women during filling phase and study the influence of (visual and cognitive) stimuli on bladder activity. We want to explore if there is a relation between non-micturation bladder activity and the sensation of urgency during the filling phase in male patients with Lower urinary tract symptoms. In order to gain a better understanding in bladder (patho)physiology.
Study design: A pilot observational study to describe the non-micturation bladder activity and sensation measurement during filling phase.
Study population:
The study population consists of two groups. First a group of patients (female) who will undergo an ambulatory urodynamic investigation to investigate their bladder complaints. All patients will be older than 18 years. The second group consists of male patients who will undergo a conventional urodynamic investigation in the normal work up for their lower urinary tract symptoms. All patients will be older than 18 years.
Condition |
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Lower Urinary Tract Symptoms Overactive Bladder Syndrome |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Non-Micturation Bladder Activity in Relation to Self-Consciousness During Filling Phase and Sensation Measurement During the Filling Phase |
Estimated Enrollment: | 50 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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2
male patients with lower urinary tract symptoms
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1
Female patients with overactive bladder syndrome
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Male patients with lower urinary tract symptoms Female patients with overactive bladder syndrome
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
University Hospital Maastricht | |
Maastricht, Netherlands, 6202 AZ |
Principal Investigator: | Sajjad Rahnama'i, MD | Maastricht University Hospital |
Study Director: | Gommert van koeveringe, MD | Maastricht University Hospital |
Responsible Party: | University hospital Maastricht ( Maastricht University ) |
Study ID Numbers: | MEC 08-2-029 |
Study First Received: | February 25, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00628615 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Urodynamics Overactive bladder syndrome Lower urinary tract symptoms LUTS |
Signs and Symptoms Urinary Bladder, Overactive Cystocele Urologic Diseases Urinary Bladder Diseases |
Signs and Symptoms Urological Manifestations Urinary Bladder, Overactive Pathologic Processes |
Disease Urologic Diseases Syndrome Urinary Bladder Diseases |