Non-Micturation Bladder Activity in Relation to Self-Consciousness During Filling Phase and Sensation Measurement During the Filling Phase
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|ClinicalTrials.gov Identifier: NCT00628615|
Recruitment Status : Unknown
Verified December 2008 by Maastricht University Medical Center.
Recruitment status was: Active, not recruiting
First Posted : March 5, 2008
Last Update Posted : December 16, 2008
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.
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.
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 or disease|
|Lower Urinary Tract Symptoms Overactive Bladder Syndrome|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Non-Micturation Bladder Activity in Relation to Self-Consciousness During Filling Phase and Sensation Measurement During the Filling Phase|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||April 2009|
|Estimated Study Completion Date :||June 2009|
male patients with lower urinary tract symptoms
Female patients with overactive bladder syndrome
- To characterise non-micturition activity during normal bladder filling [ Time Frame: 2008-2009 ]
- To determine the nature of any change in this activity associated with OAB [ Time Frame: 2008-2009 ]
- To relate this activity to bladder volume and sensation. [ Time Frame: 2008-2009 ]
- To demonstrate the micromotions [ Time Frame: 2008-2009 ]
- To study the link between OAB and micromotions in relation to bladder neck obstruction [ Time Frame: 2008-2009 ]
- To identify possible mechanisms underlying OAB [ Time Frame: 2008-2009 ]
- To gain ideas for a better treatment for OAB [ Time Frame: 2008-2009 ]
- To explore the possibility that therapeutically important drugs for OAB exert their action via inhibition of non-micturition activity [ Time Frame: 2008-2009 ]
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): NCT00628615
|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|