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Completed

NCT Number: NCT00971646

Cohort Study: Perceptual Urge Sensation

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.

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Key information

Conditions

Urinary Bladder, Overactive Bone Diseases Bone Diseases, Metabolic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Centre

Maastricht, Limburg, 6202 AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Micturition diary

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

Other

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

EuroQol-5D

Other

This questionnaire grades the health condition of the subject.

Self-consciousness questionnaire

Other

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

Primary outcomes

  1. Defining differences in self-consciousness and HADS scores in patients with OAB

    Time frame: 1 year

Secondary outcomes

  1. Defining differences between self-consciousness and HADS scores between the two cohorts

    Time frame: 1 year

  2. Defining differences in quality of life between the two cohorts

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Sep 4, 2009
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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