ANZCTR - Registration

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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

6-month intervals, for 3 years

Secondary outcome [1]

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]

At 6-monthly intervals, for 3 years

Secondary outcome [2]

Patient satisfaction, assessed by patient self-report in the questionnaire designed specifically for PPP.

Timepoint [2]

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?

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]

Mercy Hospital for Women - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

MRFWB - Medical Research Foundation for Women and Babies

Address [1]

Level 1, 459 Toorak Road,
Toorak, Victoria, 3142

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mercy Health HREC

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

02/12/2014

Approval date [1]

09/01/2015

Ethics approval number [1]

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

Prof Sonia Grover

Address

The Royal Children's Hospital Melbourne
3 West Clinical Offices
50 Flemington Road
Parkville 3052

Country

Australia

Phone

+61 3 9345 4784

Fax

+61 3 9345 5034

[email protected]

Contact person for public queries

Name

Samantha Mooney

Address

Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 84584444

Fax

[email protected]

Contact person for scientific queries

Name

Sonia Grover

Address

The Royal Children's Hospital Melbourne
3 West Clinical Offices
50 Flemington Road
Parkville 3052

Country

Australia

Phone

+61 3 9345 4784

Fax

[email protected]

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

Type	Is Peer Reviewed?	Citations or Other Details
Study results article	Yes	Pelvic Pain: what are the symptoms and predictors ... [More Details]
Study results article	Yes	Mirowska-Allen KL, Sewell M, Mooney S, Maher P, Ia... [More Details]
Study results article	Yes	Chronic pelvic pain - pain catastrophizing, pelvic... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Pelvic pain: What are the symptoms and predictors for surgery, endometriosis and endometriosis severity.	2021	https://dx.doi.org/10.1111/ajo.13379
Embase	The persistent pelvic pain study: Factors that influence outcomes in women referred to a public hospital with chronic pelvic pain - A study protocol.	2021	https://dx.doi.org/10.1111/ajo.13289

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically