Cohort Study: Perceptual Urge Sensation

NCT ID: NCT00971646

Last Updated: 2018-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2017-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Bladder, Overactive Osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OAB

Patients with overactive bladder syndrome

Micturition diary

Intervention Type OTHER

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

Intervention Type OTHER

This questionnaire is designed to screen for the presence of a mood disorder.

EuroQol-5D

Intervention Type OTHER

This questionnaire grades the health condition of the subject.

Self-consciousness questionnaire

Intervention Type OTHER

The questions tap cognitive, emotional, and physical appearance aspects of directing their attention to the self.

Osteoporosis

Patients with osteoporosis

Micturition diary

Intervention Type OTHER

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

Intervention Type OTHER

This questionnaire is designed to screen for the presence of a mood disorder.

EuroQol-5D

Intervention Type OTHER

This questionnaire grades the health condition of the subject.

Self-consciousness questionnaire

Intervention Type OTHER

The questions tap cognitive, emotional, and physical appearance aspects of directing their attention to the self.

Interventions

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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.

Intervention Type OTHER

Hospital Anxiety and Depression scale

This questionnaire is designed to screen for the presence of a mood disorder.

Intervention Type OTHER

EuroQol-5D

This questionnaire grades the health condition of the subject.

Intervention Type OTHER

Self-consciousness questionnaire

The questions tap cognitive, emotional, and physical appearance aspects of directing their attention to the self.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.


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

Exclusion Criteria

* 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.


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gommert van Koeveringe, MD, PhD, urologist

Role: STUDY_DIRECTOR

Maastricht University Medical Centre

Locations

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Maastricht University Medical Centre

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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09-1234567

Identifier Type: -

Identifier Source: org_study_id

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