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The Role of microRNAs in Organ Remodeling in Lower Urinary Tract Dysfunction

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ClinicalTrials.gov Identifier: NCT01482676
Recruitment Status : Completed
First Posted : November 30, 2011
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Urgency, frequency and incomplete emptying are the key symptoms of lower urinary tract dysfunction, including bladder pain syndrome/interstitial cystitis, and overactive bladder syndrome. Lower urinary tract dysfunction is associated with cellular stress, leading to changes in gene expression and consequent organ remodeling. MicroRNAs are small regulatory molecules, affecting protein synthesis. They are quickly winning recognition as potential therapeutic agents. The investigators will perform a comparative study of mRNAs changed in lower urinary tract dysfunction and address the role of differentially expressed miRNAs in regulation of the genes, important for bladder function. The experimental approach, combining the analysis of human biopsy material with the in vitro cell-based models, will allow the investigators to elucidate the effects of miRNAs on the expression of receptors, contractile proteins and tight junction proteins. Once the disease-induced miRNAs have been characterised and their target genes validated, it will be possible to influence their expression levels thus counter-acting their effects.

The investigators' work addresses fundamental mechanisms of signal transduction in urothelium and smooth muscle during cellular stress caused by inflammation or bladder outlet obstruction, and its regulation in the diseased state. The investigators' findings will further the knowledge of the molecular mechanisms of lower urinary tract dysfunction and have implications for diagnosis and treatment. Additionally, they have relevance for other clinical conditions, where miRNAs are implicated.


Condition or disease
Prostatic Hyperplasia Urinary Bladder Neck Obstruction Cystitis, Interstitial

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Investigating the Role of microRNAs in the Regulation of Gene Expression and Organ Remodeling During Lower Urinary Tract Dysfunction, Including Bladder Pain Syndrome/Interstitial Cystitis (BPS), and Overactive Bladder Syndrome (OAB)
Study Start Date : October 2010
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
controls (normal bladder function)
2
acontractile bladder
3
overactive bladder
4
bladder pain syndrome


Outcome Measures

Primary Outcome Measures :
  1. Molecular traits of bladder dysfunction [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. MiRNA expression profiling of individual groups [ Time Frame: 3 years ]
  2. Protein expression profiling of individual groups [ Time Frame: 3 years ]
  3. Functional differences between groups [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Frozen cold-cut bladder biopsies preserved in RNAlater buffer or in SDS-PAGE sample buffer; PFA-fixed tissue, primary cultures of urothelium and smooth muscle

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients Department of Urology, Inselspital Bern, Switzerland
Criteria

Inclusion Criteria:

  • prostate hyperplasia
  • bladder acontractility
  • bladder pain
  • age over 18 years old
  • willingness to participate (informed concent)

Exclusion Criteria

  • Age ≤ 18 years old
  • Pregnancy
  • History of or current genito-urinary tuberculosis
  • History of pelvic surgery in the last 6 months
  • History of bladder malignancy, high grade dysplasia or carcinoma in situ
  • sexually transmitted diseases (STD's)
  • Bacteriuria
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482676


Locations
Switzerland
Department of Urology, Bern University hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Katia Monastyrskaya, PhD Department of Urology, Bern University hospital
More Information