Non-Micturation Bladder Activity in Relation to Self-Consciousness During Filling Phase and Sensation Measurement During the Filling Phase

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Maastricht University Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00628615
First received: February 25, 2008
Last updated: December 15, 2008
Last verified: December 2008
  Purpose

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
Lower Urinary Tract Symptoms
Overactive Bladder Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Non-Micturation Bladder Activity in Relation to Self-Consciousness During Filling Phase and Sensation Measurement During the Filling Phase

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • To characterise non-micturition activity during normal bladder filling [ Time Frame: 2008-2009 ] [ Designated as safety issue: No ]
  • To determine the nature of any change in this activity associated with OAB [ Time Frame: 2008-2009 ] [ Designated as safety issue: No ]
  • To relate this activity to bladder volume and sensation. [ Time Frame: 2008-2009 ] [ Designated as safety issue: No ]
  • To demonstrate the micromotions [ Time Frame: 2008-2009 ] [ Designated as safety issue: No ]
  • To study the link between OAB and micromotions in relation to bladder neck obstruction [ Time Frame: 2008-2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify possible mechanisms underlying OAB [ Time Frame: 2008-2009 ] [ Designated as safety issue: No ]
  • To gain ideas for a better treatment for OAB [ Time Frame: 2008-2009 ] [ Designated as safety issue: No ]
  • To explore the possibility that therapeutically important drugs for OAB exert their action via inhibition of non-micturition activity [ Time Frame: 2008-2009 ] [ Designated as safety issue: No ]

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
2
male patients with lower urinary tract symptoms
1
Female patients with overactive bladder syndrome

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Male patients with lower urinary tract symptoms Female patients with overactive bladder syndrome

Criteria

Inclusion Criteria:

  • Male patients with lower urinary tract symptoms
  • Female patients with overactive bladder syndrome

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628615

Locations
Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Sajjad Rahnama'i, MD Maastricht University Hospital
Study Director: Gommert van koeveringe, MD Maastricht University Hospital
  More Information

No publications provided

Responsible Party: Maastricht University, University hospital Maastricht
ClinicalTrials.gov Identifier: NCT00628615     History of Changes
Other Study ID Numbers: MEC 08-2-029
Study First Received: February 25, 2008
Last Updated: December 15, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Urodynamics
Overactive bladder syndrome
Lower urinary tract symptoms LUTS

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

ClinicalTrials.gov processed this record on April 20, 2014