Cohort Study: Perceptual Urge Sensation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00971646
First received: September 3, 2009
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

Over the past few years it has become clear that our understanding of bladder physiology is inadequate to explain urge incontinence. This has forced us to re-evaluate what we know and do not know about bladder function and dysfunction. This has led to the identification and study of novel systems within the bladder that may contribute to abnormal sensations.

The investigators now suspect that the organic changes occurring in the bladder are not the whole story. For one group of patients with pathological urge there is growing evidence suggesting that there may be a strong psychological component. The idea now being put forward is that normal afferent peripheral information is perceived as abnormal and excessive, resulting in an increased desire to go to the bathroom: 'perceptual urge'. It is important to identify this group of patients since it will direct their treatment towards more cognitive approaches. Also, if such a psychological aetiology can be eliminated it would lead to a more focused and effective management of peripheral pathology with surgery or pharmacology.


Condition Intervention
Urinary Bladder, Overactive
Osteoporosis
Other: Micturition diary
Other: Hospital Anxiety and Depression scale
Other: EuroQol-5D
Other: Self-consciousness questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study: Perceptual Urge Sensation

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Defining differences in self-consciousness and HADS scores in patients with OAB [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Defining differences between self-consciousness and HADS scores between the two cohorts [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Defining differences in quality of life between the two cohorts [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: June 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
OAB
Patients with overactive bladder syndrome
Other: Micturition diary
On the micturition diary patients are asked to note every void and drink. With every void they are asked to estimate their bladder volume and grade their degree of desire to void.
Other: Hospital Anxiety and Depression scale
This questionnaire is designed to screen for the presence of a mood disorder.
Other: EuroQol-5D
This questionnaire grades the health condition of the subject.
Other: Self-consciousness questionnaire
The questions tap cognitive, emotional, and physical appearance aspects of directing their attention to the self.
Osteoporosis
Patients with osteoporosis
Other: Micturition diary
On the micturition diary patients are asked to note every void and drink. With every void they are asked to estimate their bladder volume and grade their degree of desire to void.
Other: Hospital Anxiety and Depression scale
This questionnaire is designed to screen for the presence of a mood disorder.
Other: EuroQol-5D
This questionnaire grades the health condition of the subject.
Other: Self-consciousness questionnaire
The questions tap cognitive, emotional, and physical appearance aspects of directing their attention to the self.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population consists of two groups: 1: patients with OAB; 2: patients with osteoporosis.

The patients with OAB will be reqruited from the outpatient clinic and website designed for patients with overactive bladder symptoms.

The patients with osteoporosis will be recruited from an electronic patient database.

Criteria

Inclusion Criteria (for patients with OAB):

  • Patients older than 18 years with OAB diagnosed by their urologist using the criteria of more than 8 micturitions on three consecutive days of these three days they keep a micturation diary with a VAS score for urge sensation.

Patients should have at least one episode of urge: sudden compelling desire to void which can not be postponed.

  • Well versed in Dutch.

Inclusion Criteria (for patients with osteoporosis):

  • Patients older than 18 years with osteoporosis joined into the Fast Guide cohort program.
  • Well versed in Dutch.

Exclusion Criteria (for patients with OAB):

  • Patients with stress-urinary incontinence
  • Presence of post void residual urine > 100cc determined by ultrasound
  • Presence of urinary tract infection, determined by urine sticks. Patients with urinary tract infection will be treated by antibiotics. After resolution of the infection, the patient can re-enter the study if the urine is sterile at that moment.

Exclusion Criteria (for patients with osteoporosis):

  • Urinary complaints or urologic history
  • Presence of postvoid residual urine > 100cc determined by ultrasound
  • Presence of urinary tract infection, determined by urine sticks. Patients that present with urinary tract infection will be definitively excluded from participation.
  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: NCT00971646

Contacts
Contact: Rhea Heeringa, MD 0031433872722 r.heeringa@mumc.nl
Contact: Gommert Koeveringe, MD,Phd,Urologist 0031433875255 g.van.koeveringe@mumc.nl

Locations
Netherlands
Maastricht University Medical Centre Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Rhea Heeringa, MD    0031433872722    r.heeringa@mumc.nl   
Principal Investigator: Rhea Heeringa, MD         
Sub-Investigator: Stefan de Wachter, MD,PhD,Urologist         
Sub-Investigator: R. de Bie, Prof.         
Sub-Investigator: James Gillespie, Prof         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Director: Gommert 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 Center
ClinicalTrials.gov Identifier: NCT00971646     History of Changes
Other Study ID Numbers: 09-1234567
Study First Received: September 3, 2009
Last Updated: July 14, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
overactive bladder
self-consciousness
perceptual urge sensation

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

ClinicalTrials.gov processed this record on July 22, 2014