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Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis

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ClinicalTrials.gov Identifier: NCT03023241
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld

Brief Summary:
To identify new, simple and reliable biomarkers for bladder pain syndrome/interstitial cystitis (BPS/IC) for diagnosis of this disease.

Condition or disease Intervention/treatment Phase
Bladder Pain Syndrome Interstitial Cystitis Overactive Bladder Procedure: biopsy Not Applicable

Detailed Description:
Collection and analyses of bladder biopsies, bladder washings, blood and urine samples of patients with bladder pain syndrome/interstitial cystitis (BPS/IC), overactive bladder syndrome (OAB) and bladder-healthy controls. Analyses include ELISA, RT-qPCR, DNA sequencing, and immunohistochemistry techniques. Differences between patient groups are statistically evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis
Study Start Date : December 2004
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: all study patients
Same intervention for all subjects: anamnesis, questionnaires and biological samples (bladder biopsy, bladder washing, blood and urine) are collected at one single visit.
Procedure: biopsy
cold cup bladder biopsies and bladder washings under anesthesia, blood and urine collection




Primary Outcome Measures :
  1. Identification of new diagnostic markers for BPS/IC [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Identification of molecular details that lead to BPS/IC (pathogenesis). [ Time Frame: 2 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient with diagnosed BPS/IC, OAB or healthy controls
  • included healthy controls must have another pelvic surgery planned (e.g. hysterectomy)
  • being able to act and judge

Exclusion Criteria:

  • unstable endocrinological situation
  • severe illness

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): NCT03023241


Contacts
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Contact: Marianne Gamper, Dr. +41 52 723 81 69 marianne.gamper@stgag.ch

Locations
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Switzerland
Cantonal Hospital Frauenfeld Recruiting
Frauenfeld, Thurgau, Switzerland, 8501
Contact: Volker Viereck, MD       volker.viereck@stgag.ch   
Contact: Marianne Gamper, PhD       marianne.gamper@stgag.ch   
Sponsors and Collaborators
Cantonal Hospital, Frauenfeld
Investigators
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Principal Investigator: Volker Viereck, Prof. Dr. Cantonal Hospital Frauenfeld, Switzerland

Publications of Results:
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Responsible Party: Prof. Dr. Volker Viereck, Prof. Dr. med., Cantonal Hospital, Frauenfeld
ClinicalTrials.gov Identifier: NCT03023241     History of Changes
Other Study ID Numbers: 9900.013 BPS/IC study
KEKTGOV2010/01 ( Other Identifier: Canton Thurgau Ethics Commission )
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld:
BPS/IC
OAB

Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Syndrome
Urinary Bladder, Overactive
Somatoform Disorders
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Mental Disorders