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Trial registered on ANZCTR


Registration number
ACTRN12623000459628
Ethics application status
Approved
Date submitted
5/04/2023
Date registered
3/05/2023
Date last updated
17/04/2024
Date data sharing statement initially provided
3/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Waitlist management for persistent pelvic pain patients waiting to see a specialist gynaecology clinic in Melbourne, Australia.
Scientific title
A Randomised Controlled Trial to evaluate the effect of active management of persistent pelvic pain compared to existing management for patients on the waitlist for a specialist gynaecology clinic in Melbourne, Australia.
Secondary ID [1] 309389 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent Pelvic Pain 329619 0
Condition category
Condition code
Anaesthesiology 326542 326542 0 0
Pain management
Public Health 326543 326543 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients referred by their GP to the Gynaecology specialist clinic as the Mercy Hospital for Women with persistent pelvic pain will be identified and contacted for participation in this study. Consenting patients will be randomly allocated equally to the study's control or active arm.
Active arm: patients will be triaged and placed on the waitlist the same as the control group, however the GP will be also sent education and guidelines on how to manage the patient’s persistent pelvic pain (PPP) prior to the first appointment. In this group it will be communicated with the GP that it is expected that the GP will initiate treatment according to these guidelines prior to the patient being seen in clinic from this point, patients will be seen by their GPs as per the GP's discretion. The aim of management whilst on the waitlist will be to manage the PPP by stopping their periods and becoming amenorrhoeic. GPs will have the ability to communicate routinely with the specialist clinic via an email address for any questions which will be checked weekly by a clinician from the clinic.
Like the control group, patients in the active group will eventually be seen in the gynaecology specialist clinic at the Mercy as per waitlist times. They would however been managed while waiting for their initial visit in clinic.
GPs will be provided with a hormone management plan aimed to create amenorrhoea, or as close to as possible, and with as few side effects as possible. This is a standard guideline in the treatment of persistent pelvic pain that includes: Combined oral Contraceptive Pill (OCP), Progesterone only option and long-acting reversible contraceptives (IUD).
Intervention period depends on the Mercy's gynaecology specialist clinic waitlist times, currently this is estimated at 12 months.
At the 12 months mark, GPs will be asked to complete a satisfaction survey. They will be asked to note the number of times the patient was seen by them for pelvic pain complaints in the previous 12 months and whether the patient followed the recommended course of treatment, as provided by the Mercy Hospital for Women gynaecology specialists.
Intervention code [1] 325884 0
Treatment: Other
Comparator / control treatment
The control group will be the existing model of care for patients referred with PPP to the gynaecology specialist clinic at the Mercy Hospital for Women. For this group, as per existing clinic model – once referred, patients will be triaged according to urgency of treatment and placed on the waitlist until seen at clinic for the first time, this could take up to 12 months.
While waiting to be seen at the gynaecology specialist clinic patients will be free to consult their GPs for pelvic pain management if they wish to.
Control group
Active

Outcomes
Primary outcome [1] 334384 0
A reduction in patient's most bothersome pain symptom from referral to first appointment in clinic, in the active group compared to the control group using a Visual Analogue Scale (VAS) of 0-10 where 0 represents 'no pain' and 10 'most imaginable pain'.
Timepoint [1] 334384 0
Baseline, 6 months and 12 months (first appointment in clinic) post-commencement of intervention/post randomisation.
Secondary outcome [1] 420455 0
The number of patients not requiring specialist appointment due to adequate management of pain prior to first appointment in the active group compared with the control group. This will be assessed by following up on patients who do not attend their first appointment to determine the reason for non-attendance.
Timepoint [1] 420455 0
12 months (first appointment in clinic) after intervention where patients who do not attend their first appointment will be contacted to determine the reason for non-attendance.
Secondary outcome [2] 420456 0
Number of GP appointments/ED visits/inpatient hospitalizations due to persistent pelvic pain in the active group compared with the control group. This will be assessed through audit of patient medical records.
Timepoint [2] 420456 0
6 and 12 months (first visit to clinic) post-commencement of intervention/post randomisation.

Eligibility
Key inclusion criteria

• Patients aged 18 years or older referred to the general gynaecology clinic whose primary or secondary complain is persistent pelvic pain (pain occurring for >3 months)
• English speakers
• Pre-menopausal
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

• Pregnancy or actively trying to conceive
• Breastfeeding
• Current actively managed malignancy
• Other unstable medical or surgical condition that may impact management of persistent pelvic pain
• Inability to provide informed consent
• Prior hysterectomy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE ESTIMATION & JUSTIFICATION
Sample size requirements are estimated based on the primary outcome. Assuming that 10% of patients in the control group will achieve a clinically significance improvement between initiation of the trial and time of first visit (i.e., the lower of 30% or a two-point improvement, A total sample size of 266 (133 randomised to each group) at analysis would provide 90% power to detect a difference in proportions as small as 15% between the active and control groups at an alpha level of 0.05. We further assume that up to 30% of recruited participants may be lost to follow-up. As such, we will initially recruit 190 patients per group (380 in total) to ensure an adequate sample size for analysis.
DATA ANALYSIS
Sample characteristics will be summarised using means (and standard deviations) for continuous variables, and frequencies (and relative frequencies) for categorical variables.
A generalised linear model (binomial distribution with a log-link function) will be used to compare active management and existing waitlist control groups on the primary outcome (the proportion of patients who achieve a clinically significant improvement of two-points or 30%, whichever is reached first).
Secondary outcomes will be analysed using generalised linear models (Poisson regression) for count measures, and general linear models for satisfaction scores.
Additional exploratory analysis will stratify participants according to complexity of their pain. A compounded pain score will be created to stratify pain according to the criteria in the IASP classification of chronic pain and the presence of additional chronic pelvic comorbidities. This will be included in regression models by way of an interaction term between pain complexity and study arm. This will allow testing of hypotheses according to level of complexity of pain and will enable identification of specific groups of patients for which active waitlist management of pain may be more beneficial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/05/2023
Actual
11/09/2023
Date of last participant enrolment
Anticipated
15/05/2024
Actual
Date of last data collection
Anticipated
15/05/2025
Actual
Sample size
Target
380
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24479 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 40063 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 313584 0
Hospital
Name [1] 313584 0
Mercy Hospital for Women, Heidelberg
Country [1] 313584 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
University of Melbourne. Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 315369 0
None
Name [1] 315369 0
Address [1] 315369 0
Country [1] 315369 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312762 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 312762 0
Ethics committee country [1] 312762 0
Australia
Date submitted for ethics approval [1] 312762 0
20/12/2022
Approval date [1] 312762 0
05/09/2023
Ethics approval number [1] 312762 0
2022-038

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125818 0
A/Prof Emma Readman
Address 125818 0
Mercy Hospital for Women. 163 Studley Rd, Heidelberg VIC 3084
Country 125818 0
Australia
Phone 125818 0
+613 8345 2198
Fax 125818 0
Email 125818 0
[email protected]
Contact person for public queries
Name 125819 0
Michal Zelcer
Address 125819 0
Mercy Hospital for Women. 163 Studley Rd, Heidelberg VIC 3084
Country 125819 0
Australia
Phone 125819 0
+61 479179222
Fax 125819 0
Email 125819 0
[email protected]
Contact person for scientific queries
Name 125820 0
Emma Readman
Address 125820 0
Mercy Hospital for Women. 163 Studley Rd, Heidelberg VIC 3084
Country 125820 0
Australia
Phone 125820 0
+613 8345 2198
Fax 125820 0
Email 125820 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.