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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital Inselspital, Berne
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01482676
First received: November 17, 2011
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MiRNA expression profiling of individual groups [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Protein expression profiling of individual groups [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Functional differences between groups [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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


Estimated Enrollment: 80
Study Start Date: October 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
controls (normal bladder function)
2
acontractile bladder
3
overactive bladder
4
bladder pain syndrome

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482676

Contacts
Contact: Fiona C Burkhard, Prof Dr med +41 31 632 36 41 Fiona.Burkhard@insel.ch
Contact: Katia Monastyrskaya, PhD + 41 31 632 87 19 monastyk@dkf.unibe.ch

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

Publications:
Responsible Party: PD Dr Katia Monastyrskaya, Urology Research Laboratory, Department Clinical Research, University of Bern
ClinicalTrials.gov Identifier: NCT01482676     History of Changes
Other Study ID Numbers: 146/05b
Study First Received: November 17, 2011
Last Updated: January 11, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Hyperplasia
Prostatic Hyperplasia
Urinary Bladder Neck Obstruction
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Urethral Diseases
Urethral Obstruction
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014