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Completed

NCT Number: NCT01114412

Basic Sensations Coming From the Bladder

A major complication in studies to identify the nature of bladder sensations is language. It is difficult, if not near impossible, for the lay person, with no knowledge of physiology, anatomy or pathology, to put into simple terms a description of basic visceral sensations. Therefore, before the investigators can speculate about the detailed mechanisms generating sensation the investigators must overcome this language and communication difficulty. This will be addressed in the present study.

There are important reasons why the investigators must identify the mechanisms generating the different sensations as the bladder fills. One of them is that these are basic physiological mechanisms which need to be better understood.

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Key information

Conditions

Healthy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive 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, 6202 AZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy volunteers

  • Healthy students from The University of Maastricht well versed in Dutch.

Patients

  • Patients with OAB diagnosed by their urologist using the criteria of more than 8 micturitions on three consecutive days. Before the start of any anticholinergic or other therapy. Patients on anticholinergic therapy will be asked to stop this therapy for at least 10 days before they enter the first session.
  • Well versed in Dutch.

Exclusion criteria

Healthy volunteers

  • Use of any medication (except oral contraceptives)
  • Surgical history of the abdomen
  • Urinary complaints (e.g. frequency, urgency)
  • Urinary tract infection

Patients:

  • Congestive heart disease or history of heart failure
  • Presence of urinary tract infection. These patients will be treated by antibiotics.

Treatment and study plan

Primary outcomes

  1. description of bladder sensations

    The primary objective of this experiment is to address how medical students and patients with OAB describe the sensations they feel during the filling phase of the bladder.

    Primary objectives

    • To put into simple terms a description of basic visceral sensations coming from the bladder
    • Describe the pattern of normal sensations during filling

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Description of Basic Visceral Sensations Coming From the Bladder

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 3, 2010
Registry last updated
Aug 23, 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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