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

This study has been completed.
Information provided by (Responsible Party):
University Hospital Inselspital, Berne Identifier:
First received: November 17, 2011
Last updated: June 1, 2015
Last verified: June 2015

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.

Prostatic Hyperplasia Urinary Bladder Neck Obstruction Cystitis, Interstitial

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by University Hospital Inselspital, Berne:

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

Secondary Outcome Measures:
  • MiRNA expression profiling of individual groups [ Time Frame: 3 years ]
  • Protein expression profiling of individual groups [ Time Frame: 3 years ]
  • 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

Enrollment: 103
Study Start Date: October 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
controls (normal bladder function)
acontractile bladder
overactive bladder
bladder pain syndrome

  Show Detailed Description


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

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
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Please refer to this study by its identifier: NCT01482676

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