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Trial registered on ANZCTR


Registration number
ACTRN12616000150448
Ethics application status
Approved
Date submitted
2/02/2016
Date registered
9/02/2016
Date last updated
9/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Persistent Pelvic Pain (PPP) Study: Factors influencing the outcomes in women presenting with persistent pelvic pain
Scientific title
The Persistent Pelvic Pain Study (PPP): Factors influencing the outcomes in women presenting with persistent pelvic pain
Secondary ID [1] 288461 0
nil known
Universal Trial Number (UTN)
U1111-1179-1121
Trial acronym
PPP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic/Persistent Pelvic Pain 297490 0
Condition category
Condition code
Reproductive Health and Childbirth 297678 297678 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
On presentation, participants will complete a questionnaire including 1) The Pain Catastrophizing Scale (PCS), 2) The World Health Organisation Quality of life - Bref Questionnaire, and 3) their pelvic pain levels in the last 3 months. All clinical decisions regarding management will be independent of study questionnaires. Follow-up questionnaires at 6 monthly intervals will be sent. We will recruit for 18months, and the study will conclude follow-up at a minimum of 36 months for each patient. The follow-up period is based on an attrition rate of 30% (gauged from original pilot data). Data will be analysed at each 12-month point - if clinically significant outcomes are determined, the option of gaining ethics for an extension of the follow-up period will be explored.
Intervention code [1] 293795 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297217 0
The study aims to clarify factors that impact on outcomes for women presenting with persistent pelvic pain (PPP). We are utilising a specifically devised questionnaire, which incorporates Likert-scales for determining 5 facets of pelvic pain - dyspareunia, dysmenorrhoea, dyschezia, dysuria and chronic (non-cyclical) pelvic pain, as well as overall patient satisfaction assessment. Also, the WHO QOL-Bref and Pain catastophisation scores (PCS) will be employed.
Timepoint [1] 297217 0
6-month intervals, for 3 years
Secondary outcome [1] 320376 0
Management modality. This will be assessed by both a questionnaire (designed specifically for PPP), as well a medical records review. Surgical notes will be reviewed as indicated.
Timepoint [1] 320376 0
At 6-monthly intervals, for 3 years
Secondary outcome [2] 320377 0
Patient satisfaction, assessed by patient self-report in the questionnaire designed specifically for PPP.
Timepoint [2] 320377 0
At 6-montly intervals, for 3 years

Eligibility
Key inclusion criteria
A longitudinall study including women aged 18 – 50 years with persistent pelvic pain, referred to a tertiary gynaecology hospital.
Inclusion criteria: patients with referrals for clinical symptoms such as pelvic pain, dysmenorrhoea, dyspareunia, non-menstrual pelvic pain, lower abdominal pain or dyschezia.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women are to be excluded if they are actively trying to conceive, are under investigation for infertility, have recent ultrasound evidence of a large (>4cm) complex ovarian cyst or endometrioma, or have a past history of hysterectomy.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be collected at 6-monthly intervals, and entered into the confidential database. We plan statistical analysis to be performed using the STATA Data Analysis and Statistical Software (STATACorp, USA, Version 13). A p-value < 0.05 will be considered statistically significant for all comparisons. Association between variables will be analysed using appropriate correlation tests and logistic regression models.
A pilot project was conducted for 12months, to assess the feasibility for the project design, as well as to determine numbers and attrition rates. Approximately 35-40 patients are eligible for inclusion each month. Only 70% of these attend clinic, the remainder are unable to be recruited. Of these, approximately 28-30 are recruited each month, giving an overall recruitment rate of ~70%. At 6month, of those that we have approached for followup, we have a 60% response rate. We aim to improve this with repeat patient contact.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/02/2015
Date of last participant enrolment
Anticipated
8/02/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5217 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 12687 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 292805 0
Charities/Societies/Foundations
Name [1] 292805 0
MRFWB - Medical Research Foundation for Women and Babies
Country [1] 292805 0
Australia
Primary sponsor type
Individual
Name
Prof Sonia Grover
Address
The Royal Children's Hospital Melbourne
3 West Clinical Offices
50 Flemington Road
Parkville 3052
Country
Australia
Secondary sponsor category [1] 291543 0
None
Name [1] 291543 0
Address [1] 291543 0
Country [1] 291543 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294305 0
Mercy Health HREC
Ethics committee address [1] 294305 0
Att: Carole Branch,
Administrative Officer, Mercy Health Human Research Ethics Committee (Mercy Health HREC)
c/o: Mercy Hospital for Women
163 Studley Road
Heidelberg, VIC 3084
Ethics committee country [1] 294305 0
Australia
Date submitted for ethics approval [1] 294305 0
02/12/2014
Approval date [1] 294305 0
09/01/2015
Ethics approval number [1] 294305 0
R14/31

Summary
Brief summary
AIMS: This study aims to clarify factors impacting upon outcomes in women presenting with persistent pelvic pain (PPP). The study team are keen to understand whether there are specific features of the woman, including the type and severity of the pain, the duration of these symptoms, or her response to her pain, that might influence or predict her outcome and thus potentially allow selection of the most appropriate therapeutic approach for specific patient characteristics.

METHODS:
Pelvic pain is the most common indication for referral to the outpatient gynaecology clinic. Information regarding this study, including study information, consent, and questionnaires regarding symptoms, quality of life(QoL), pain catastrophisation scale(PCS), will be sent to patients at the same time as their appointment information.

On arrival at their first appointment, the research assistant will approach the prospective participants to ensure that initial paperwork and questionnaires were received, and offer the opportunity for questions. If the patient agrees to participate and has not completed the questionnaires they will be encouraged to do so whilst waiting. Consent to access patient data from medical records will also be sought. All clinical decisions regarding management will be independent of study questionnaires. Clinicians, who with the patient, decide that surgery for the PPP is warranted, will be asked to complete a brief survey regarding the factors influencing this decision.

Follow-up questionnaires at 6 monthly intervals will be sent (either electronic, utilising survey monkey, or in paper format with reply paid envelopes, depending on patient preference). The pilot study will conclude at a minimum of 36 months. Patient questionnaires will take 15-30minutes.
Trial website
Trial related presentations / publications
Two abstracts have been submitted to the APS Conference (scheduled for March 2016). The following have been accepted for oral presentations:

PERSISTENT PELVIC PAIN – PREDICTORS OF SURGICAL INTERVENTION
Kelly Mirowska-Allen1, Megan Sewell 1, Samantha Mooney2, Tony Ma2, Peter Maher2, Sonia Grover2
1. University of Melbourne, Parkville, Vic., Australia
2. The Mercy Hospital for Women, Heidelberg, Vic., Australia

PERSISTENT PELVIC PAIN – PAIN CATASTROPHIZATION, PELVIC PAIN AND QUALITY OF LIFE
Megan A Sewell 1, Samantha Mooney2, Sonia R Grover2
1. University of Melbourne, Parkville, Vic., Australia
2. Department of Gynaecology, Mercy Hospital for Women, Heidelberg, Vic., Australia
Public notes

Contacts
Principal investigator
Name 63234 0
Prof Sonia Grover
Address 63234 0
The Royal Children's Hospital Melbourne
3 West Clinical Offices
50 Flemington Road
Parkville 3052
Country 63234 0
Australia
Phone 63234 0
+61 3 9345 4784
Fax 63234 0
+61 3 9345 5034
Email 63234 0
[email protected]
Contact person for public queries
Name 63235 0
Samantha Mooney
Address 63235 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 63235 0
Australia
Phone 63235 0
+61 3 84584444
Fax 63235 0
Email 63235 0
[email protected]
Contact person for scientific queries
Name 63236 0
Sonia Grover
Address 63236 0
The Royal Children's Hospital Melbourne
3 West Clinical Offices
50 Flemington Road
Parkville 3052
Country 63236 0
Australia
Phone 63236 0
+61 3 9345 4784
Fax 63236 0
Email 63236 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23411Study protocolMooney, S.S. and Grover, S.R. (2021), The persistent pelvic pain study: Factors that influence outcomes in women referred to a public hospital with chronic pelvic pain – A study protocol. Aust N Z J Obstet Gynaecol. https://doi.org/10.1111/ajo.13289  

Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Pelvic Pain: what are the symptoms and predictors ... [More Details]
Study results articleYes Mirowska-Allen KL, Sewell M, Mooney S, Maher P, Ia... [More Details]
Study results articleYes Chronic pelvic pain - pain catastrophizing, pelvic... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePelvic pain: What are the symptoms and predictors for surgery, endometriosis and endometriosis severity.2021https://dx.doi.org/10.1111/ajo.13379
EmbaseThe persistent pelvic pain study: Factors that influence outcomes in women referred to a public hospital with chronic pelvic pain - A study protocol.2021https://dx.doi.org/10.1111/ajo.13289
N.B. These documents automatically identified may not have been verified by the study sponsor.