Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2021-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Bladder Pain Syndrome Interstitial Cystitis Overactive Bladder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

biopsy

Intervention Type PROCEDURE

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

Interventions

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biopsy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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