Cohort Study: Perceptual Urge Sensation

Osteoporosis Clinical Trial

Official title:

Cohort Study: Perceptual Urge Sensation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971646
• Other study ID #: 09-1234567
• Status: Completed
• Start date: June 2010
• Est. completion date: March 1, 2017

Study information

• Verified date: September 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Urinary Bladder, Overactive

Intervention

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.
• Hospital Anxiety and Depression scale
This questionnaire is designed to screen for the presence of a mood disorder.
• EuroQol-5D
This questionnaire grades the health condition of the subject.
• Self-consciousness questionnaire
The questions tap cognitive, emotional, and physical appearance aspects of directing their attention to the self.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Defining differences in self-consciousness and HADS scores in patients with OAB		1 year
Secondary	Defining differences between self-consciousness and HADS scores between the two cohorts		1 year
Secondary	Defining differences in quality of life between the two cohorts		1 year