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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
Scientific title
Diagnosis of Interstitial Cystitis in Women with Chronic Pelvic Pain - a Prospective Observational Study
Secondary ID [1] 279916 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial Cystitis 3061 0
Chronic Pelvic Pain 3062 0
Endometriosis 3063 0
Condition category
Condition code
Other 3217 3217 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 2806 0
Diagnosis / Prognosis
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4100 0
Proportion of interstitial cystitis diagnosed in women with chronic pelvic pain.
Timepoint [1] 4100 0
At the conclusion of the study
Secondary outcome [1] 6900 0
Proportion of bladder pain syndrome diagnosied in women with chronic pelvic pain
Timepoint [1] 6900 0
At the conclusion of the study

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
Minimum age
18 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 655 0
3052
Recruitment postcode(s) [2] 656 0
3121
Recruitment postcode(s) [3] 648 0
3144

Funding & Sponsors
Funding source category [1] 3311 0
Charities/Societies/Foundations
Name [1] 3311 0
Australasian Gynaecological Endoscopy & Surgery Research Fund
Address [1] 3311 0
282 Edinburgh Road
CASTLECRAG NSW 2068
Country [1] 3311 0
Australia
Primary sponsor type
Individual
Name
Claudia Cheng
Address
Royal Women's Hospital
Grattan Street
Victoria
Country
Australia
Secondary sponsor category [1] 2962 0
None
Name [1] 2962 0
Address [1] 2962 0
Country [1] 2962 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5349 0
Ethics committee address [1] 5349 0
Ethics committee country [1] 5349 0
Date submitted for ethics approval [1] 5349 0
07/05/2008
Approval date [1] 5349 0
Ethics approval number [1] 5349 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28535 0
Address 28535 0
Country 28535 0
Phone 28535 0
Fax 28535 0
Email 28535 0
Contact person for public queries
Name 11692 0
Dr Claudia Cheng
Address 11692 0
Royal Women's Hospital
Locked Bag 300
Cnr Grattan Street and Flemington Road
Parkville 3052 Victoria
Country 11692 0
Australia
Phone 11692 0
03 8345 2000
Fax 11692 0
Email 11692 0
claudia.cheng@rwh.org.au
Contact person for scientific queries
Name 2620 0
Dr Claudia Cheng
Address 2620 0
Royal Women's Hospital
Locked Bag 300
Cnr Grattan Street and Flemington Road
Parkville 3052 Victoria
Country 2620 0
Australia
Phone 2620 0
03 8345 2000
Fax 2620 0
Email 2620 0
claudia.cheng@rwh.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary