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Investigation of the Suburothelial Myofibroblast Network and of Smooth Muscle Function and Control in the Human Urinary Outflow Tract

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Ludwig-Maximilians - University of Munich.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Alexander Roosen, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01227447
First received: October 22, 2010
Last updated: March 2, 2012
Last verified: March 2012
  Purpose
The aim is to find out if adreno-muscarinic synergy is present also in human tissues of the urinary outflow tract that have a dual adrenergic-muscarinic receptor fitting. To further characterise morphology and function of the suburothelial myofibroblast network in the human bladder outlet.

Condition
Incontinence, Overactive Bladder, Stress Urinary Incontinence

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Investigation of the Suburothelial Myofibroblast Network and of Smooth Muscle Function and Control in the Continent and Incontinent Human Urinary Outflow Tract

Further study details as provided by Ludwig-Maximilians - University of Munich:

Biospecimen Description:
Human tissue from the urinary outflow tract (bladder base and urethra) of patients undergoing cystectomy or radical prostatectomy (for cancer treatment) with pre-operatively documented voiding disorders/incontinence - in particular SUI

Estimated Enrollment: 200
Study Start Date: January 2010
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Human tissue from the urinary outflow tract (bladder base and urethra) of patients undergoing cystectomy or radical prostatectomy (for cancer treatment) with pre-operatively documented voiding disorders/incontinence - in particular SUI
Criteria

Inclusion Criteria:

Tissue will be collected from the operation theatre only after having obtained the patient´s consent and in strictest accordance with histopathological requirements, i.e. after assessment of resection margins. It might be necessary to retrieve the tissue from the pathologist after first pathological assessment is completed. Tissue will be placed in Tyrode´s solution, gassed with 95 % O2 and 5 % CO2, for functional and RT-PCR or Western blot experiments, or in OCT (optimal cutting temperature) compound, snap-frozen in liquid nitrogen, and stored in a -80°C freezer until cutting for immunohistochemical experiments.

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01227447

Locations
Germany
Ludwig Maximilians University Munich, Dep Urology
Munich, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Alexander Roosen, PD Dr LMU Munich
  More Information

Responsible Party: Alexander Roosen, PD Dr A Roosen, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01227447     History of Changes
Other Study ID Numbers: RO 3589/2-1 
Study First Received: October 22, 2010
Last Updated: March 2, 2012
Health Authority: Germany: German Research Foundation (DFG)

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urination Disorders
Behavioral Symptoms
Elimination Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 02, 2016