NCT01227447

Brief Summary

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
Last Updated

March 5, 2012

Status Verified

March 1, 2012

First QC Date

October 22, 2010

Last Update Submit

March 2, 2012

Conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig Maximilians University Munich, Dep Urology

Munich, 81377, Germany

RECRUITING

Related Publications (1)

  • Walther S, Strittmatter F, Hennenberg M, Gratzke C, Stief CG, Roosen A. Adreno-muscarinic synergy in the male human urinary outflow tract. Neurourol Urodyn. 2018 Sep;37(7):2128-2134. doi: 10.1002/nau.23578. Epub 2018 Apr 20.

Biospecimen

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

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination Disorders

Study Officials

  • Alexander Roosen, PD Dr

    LMU Munich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr A Roosen

Study Record Dates

First Submitted

October 22, 2010

First Posted

October 25, 2010

Study Start

January 1, 2010

Last Updated

March 5, 2012

Record last verified: 2012-03

Locations