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Reproductive Health
Published in: Reproductive Health 1/2013

Open Access 01-12-2013 | Study protocol

Bladder pain syndrome: validation of simple tests for diagnosis in women with chronic pelvic pain: BRaVADO study protocol

Authors: Seema A Tirlapur, Lee Priest, Daniel Wojdyla, Khalid S Khan

Published in: Reproductive Health | Issue 1/2013

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Abstract

Background

Bladder pain syndrome (BPS), a condition with no gold standard diagnosis, comprises of a cluster of signs and symptoms. Bladder filling pain and bladder wall tenderness are two basic clinical features, present in a high number of sufferers. This study will validate the performance of these simple tests for BPS in women with chronic pelvic pain (CPP).

Methods/design

We will conduct a prospective test validation study amongst women with unexplained CPP presenting to gynaecology outpatient clinics. Two index tests will be performed: patient reported bladder filling pain and bladder wall tenderness on internal pelvic bimanual examination. A final diagnosis of BPS will be made by expert consensus panel. We will assess the rates of index tests in women with CPP; evaluate the correlation between index tests and Pelvic Pain Urgency/ Frequency (PUF) questionnaire results; and determine index test sensitivity and specificity using a range of analytical methods. Assuming a 50% prevalence of BPS and an 80% power approximately 152 subjects will be required exclude sensitivity of < 55% at 70% sensitivity.

Discussion

The results of this test validation study will be used to identify whether a certain combination of signs and symptoms can accurately diagnose BPS.

Trial registration

ISRCTN13028601
Appendix
Available only for authorised users
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Metadata
Title
Bladder pain syndrome: validation of simple tests for diagnosis in women with chronic pelvic pain: BRaVADO study protocol
Authors
Seema A Tirlapur
Lee Priest
Daniel Wojdyla
Khalid S Khan
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Reproductive Health / Issue 1/2013
Electronic ISSN: 1742-4755
DOI
https://doi.org/10.1186/1742-4755-10-61

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