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CompletedNCT03023241Updated Mar 31, 2022

Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis

An interventional study of biopsy in Bladder Pain Syndrome, Interstitial Cystitis and Overactive Bladder, sponsored by Cantonal Hospital, Frauenfeld. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Cantonal Hospital, Frauenfeld · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Bladder Pain Syndrome
  • Interstitial Cystitis
  • Overactive Bladder

Keywords

  • BPS/IC
  • OAB
03

In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 300 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Cantonal Hospital, Frauenfeld is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • unstable endocrinological situation
  • severe illness
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • 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

Interventions

  • Procedurebiopsy

    cold cup bladder biopsies and bladder washings under anesthesia, blood and urine collection

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What researchers measure

Primary outcomes

  1. Identification of new diagnostic markers for BPS/IC

    Time frame: 2 days

Secondary outcomes

  1. Identification of molecular details that lead to BPS/IC (pathogenesis).

    Time frame: 2 days

07

Study locations

1 site
  • Cantonal Hospital Frauenfeld
    Frauenfeld, Thurgau 8501, Switzerland
08

References and documents

Publications

  • Gamper M, Viereck V, Geissbuhler 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. PubMed 19400928 ↗
  • 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. PubMed 23670165 ↗
  • 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. PubMed 25596361 ↗
  • 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. No abstract available. PubMed 26384156 ↗
  • 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. PubMed 27378135 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03023241
Lead sponsor
Cantonal Hospital, Frauenfeld
Responsible party
Prof. Dr. Volker Viereck (Prof. Dr. med., Cantonal Hospital, Frauenfeld) — Principal investigator
First posted
Jan 18, 2017
Start date
Dec 2004
Primary completion
Dec 2020
Completion
Jul 2021
Last update
Mar 31, 2022

Study contacts

Volker Viereck, Prof. Dr.
principal investigator · Cantonal Hospital Frauenfeld, Switzerland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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