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Trial registered on ANZCTR
Registration number
ACTRN12608000219381
Ethics application status
Approved
Date submitted
16/04/2008
Date registered
24/04/2008
Date last updated
10/02/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Diagnosis of Interstitial Cystitis in Women with Pelvic Pain
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Scientific title
Diagnosis of Interstitial Cystitis in Women with Chronic Pelvic Pain - a Prospective Observational Study
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Secondary ID [1]
279916
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Interstitial Cystitis
3061
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Chronic Pelvic Pain
3062
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Endometriosis
3063
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Condition category
Condition code
Other
3217
3217
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0
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Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Cystoscopy (+/- bladder biopsy) and questionaires to diagnose Interstitial Cystitis. Questionaires include details on demographics, pelvic pain symptoms with visual analogue scales to rate severity, urinary symptoms with Pelvic Pain and Urgency/Frequency (PUF) and O'Leary-Sant Symptom Index and Problem Index questionaires. These questionaires are given to participant at recruitment preoperatively. The duration of observation is from recruitment to the completion of the operation with or without biopsy results. There are no follow up questionaires planned at this stage.
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Intervention code [1]
2806
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Diagnosis / Prognosis
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Comparator / control treatment
n/a
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Proportion of interstitial cystitis diagnosed in women with chronic pelvic pain.
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Assessment method [1]
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Timepoint [1]
4100
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At the conclusion of the study
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Secondary outcome [1]
6900
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Proportion of bladder pain syndrome diagnosied in women with chronic pelvic pain
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Assessment method [1]
6900
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Timepoint [1]
6900
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At the conclusion of the study
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Eligibility
Key inclusion criteria
18-50 years old
Females
Presence of Pelvic pain for more than 6 months
Cause of pain unknown (except for past history of endometriosis or interstitial cystitis)
A laparoscopy is planned as part of the investigation of pelvic pain
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Does not consent
Non English Speaking
under 18 years old or over 50 years old
Presence of urinary tract infection
Likely cause (except history of endometriosis or interstitial cystitis) of pelvic pain known, such as ovarian cysts, hydrosalpinx etc.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
7/07/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
648
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3144
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Recruitment postcode(s) [2]
655
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3052
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Recruitment postcode(s) [3]
656
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3121
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Funding & Sponsors
Funding source category [1]
3311
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Charities/Societies/Foundations
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Name [1]
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Australasian Gynaecological Endoscopy & Surgery Research Fund
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Address [1]
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282 Edinburgh Road
CASTLECRAG NSW 2068
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Country [1]
3311
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Australia
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Primary sponsor type
Individual
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Name
Claudia Cheng
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Address
Royal Women's Hospital
Grattan Street
Victoria
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
2962
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Country [1]
2962
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
5349
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Ethics committee address [1]
5349
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Ethics committee country [1]
5349
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Date submitted for ethics approval [1]
5349
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07/05/2008
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Approval date [1]
5349
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Ethics approval number [1]
5349
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Summary
Brief summary
Prospective Observational study looking at the diagnosis of interstitial cystitis in women with chronic pelvic pain. Women who are booked for a laparoscopy as part of their investigation for chronic pelvic pain are recruited. Questionaires on demographics, pelvic pain symptoms and urinary symptoms are given and cystoscopy added to the procedure if not already planned for. Findings at cystoscopy such as glomerulation and Huner's ulcer, and at laparoscopy such as endometriosis and its stage, are recorded. Outcomes of proportion of these women with interstitial cystitis will be looked at. Comparison will also be made of the presenting symptoms between the groups of women who have interstitial cystitis alone; endometriosis alone,;both and neither conditions.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Claudia Cheng
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Address
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Royal Women's Hospital
Locked Bag 300
Cnr Grattan Street and Flemington Road
Parkville 3052 Victoria
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Country
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Australia
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Phone
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03 8345 2000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Claudia Cheng
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Address
2620
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Royal Women's Hospital
Locked Bag 300
Cnr Grattan Street and Flemington Road
Parkville 3052 Victoria
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Country
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Australia
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Phone
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03 8345 2000
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Fax
2620
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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