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NCT03023241 Clinical Trial

Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis

Overactive Bladder Clinical Trial

Official title:
Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03023241
Other study ID # 9900.013 BPS/IC study
Secondary ID KEKTGOV2010/01
Status Completed
Phase N/A
First received
Last updated
Start date December 2004
Est. completion date July 2021

Study information
Verified date March 2022
Source Cantonal Hospital, Frauenfeld
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date July 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• biopsy
cold cup bladder biopsies and bladder washings under anesthesia, blood and urine collection

Locations
Country Name City State
Switzerland Cantonal Hospital Frauenfeld Frauenfeld Thurgau

Sponsors (1)
Lead Sponsor Collaborator
Cantonal Hospital, Frauenfeld

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Gamper M, Moser R, Viereck V. Have we been led astray by the NGF biomarker data? Neurourol Urodyn. 2017 Jan;36(1):203-204. doi: 10.1002/nau.22882. Epub 2015 Sep 18. — View Citation

Gamper M, Regauer S, Welter J, Eberhard J, Viereck V. Are mast cells still good biomarkers for bladder pain syndrome/interstitial cystitis? J Urol. 2015 Jun;193(6):1994-2000. doi: 10.1016/j.juro.2015.01.036. Epub 2015 Jan 14. — View Citation

Gamper M, Viereck V, Eberhard J, Binder J, Moll C, Welter J, Moser R. Local immune response in bladder pain syndrome/interstitial cystitis ESSIC type 3C. Int Urogynecol J. 2013 Dec;24(12):2049-57. doi: 10.1007/s00192-013-2112-0. Epub 2013 May 14. — View Citation

Gamper M, Viereck V, Geissbühler V, Eberhard J, Binder J, Moll C, Rehrauer H, Moser R. Gene expression profile of bladder tissue of patients with ulcerative interstitial cystitis. BMC Genomics. 2009 Apr 28;10:199. doi: 10.1186/1471-2164-10-199. — View Citation

Regauer S, Gamper M, Fehr MK, Viereck V. Sensory Hyperinnervation Distinguishes Bladder Pain Syndrome/Interstitial Cystitis from Overactive Bladder Syndrome. J Urol. 2017 Jan;197(1):159-166. doi: 10.1016/j.juro.2016.06.089. Epub 2016 Jul 1. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of new diagnostic markers for BPS/IC 2 days
Secondary Identification of molecular details that lead to BPS/IC (pathogenesis). 2 days
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