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

This study is currently recruiting participants.
Verified March 2012 by Ludwig-Maximilians - University of Munich
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
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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
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:

None.

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

Contacts
Contact: Alexander Roosen, MD +49-89-7095 ext 0 alexander.roosen@med.uni-muenchen.de

Locations
Germany
Ludwig Maximilians University Munich, Dep Urology Recruiting
Munich, Germany, 81377
Contact: Roosen     +49-89-7095 ext 0        
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Alexander Roosen, PD Dr LMU Munich
  More Information

No publications provided

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 Incontinence
Urinary Incontinence, Stress
Urinary Bladder, Overactive
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on May 22, 2013