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Trial registered on ANZCTR


Registration number
ACTRN12621000516886
Ethics application status
Approved
Date submitted
15/03/2021
Date registered
3/05/2021
Date last updated
3/05/2021
Date data sharing statement initially provided
3/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pelvic floor muscle pain in women with endometriosis
Scientific title
Pelvic floor muscle tenderness in women having investigative laparoscopy for pelvic pain: a prospective cohort study
Secondary ID [1] 303695 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12620001182987: This record is a sub-study of this study. The first 30 participants of the main study will be recruited to participate in ACTRN12620001182987, for their pre-operative assessment, and then will continue on in the main study for their post-operative assessments.

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 321107 0
Persistent pelvic pain 321108 0
Pelvic floor muscle dysfunction 321109 0
Condition category
Condition code
Reproductive Health and Childbirth 318904 318904 0 0
Other reproductive health and childbirth disorders
Musculoskeletal 318905 318905 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will identify the prevalence and severity of pelvic floor muscle tenderness, increased pelvic floor muscle tone and pelvic pain symptoms in women with endometriosis-associated pelvic pain, before and after surgical treatment of endometriosis.
Women will be assessed by a pelvic floor physiotherapist at 3 time-points: before surgery, 3 months after surgery and 12 months after surgery. Duration of each assessment:
- T1 (pre-operative): 1 hour
- T2 (3 months post-operative): 45 minutes
- T3 (12 months post-operative): 45 minutes.
Assessment sites include public hospitals and private physiotherapy practices.
Assessments will follow a standardised protocol and include:
1. intra-vaginal digital palpation to assess pelvic floor muscle resting tone, tenderness, strength of contraction, ability to relax.
2. intra-vaginal algometry to assess pressure pain thresholds of the levator ani and obturator internus muscles.
3. intra-vaginal pressure manometry to assess resting pressure and squeeze pressure of the pelvic floor muscles.
No physiotherapy treatment will be provided as part of the study, however women will be free to seek physiotherapy treatment outside of the study, between the 3- and 12-month study assessment time-points.
Intervention code [1] 319994 0
Diagnosis / Prognosis
Intervention code [2] 319995 0
Early Detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326840 0
The primary outcome of this study is pressure-pain sensitivity assessed using digital palpation with an attached force sensor to record the force applied during the test (called algometry). This is a partly subjective (patient report of pain, measured on a 0 – 10 pain NRS) and a partly objective (quantifiable amount of pressure applied, measured in g/kg force) measure of pressure-pain sensitivity
Timepoint [1] 326840 0
Time 1, baseline, before surgery is the primary time-point of the study for this outcome.
However this outcome will also be assessed at subsequent time-points:
T2: 3 months after surgery
T3: 12 months after surgery
Secondary outcome [1] 392866 0
i. tenderness of pelvic floor muscles: assessed by digital palpation (clinician-estimated amount of pressure) combined with patient report of pain on a 0 – 10 pain NRS.
Timepoint [1] 392866 0
at each assessment time-point:
T1: baseline, before surgery
T2: 3 months after surgery
T3: 12 months after surgery
Secondary outcome [2] 392867 0
ii. pelvic floor muscle tone: assessed by digital palpation (clinician-estimated amount of pressure) and clinician rating of amount of resistance palpated in the PFM, rated on a 3-point scale: decreased, normal, increased
Timepoint [2] 392867 0
at each assessment time-point:
T1: baseline, before surgery
T2: 3 months after surgery
T3: 12 months after surgery
Secondary outcome [3] 392868 0
iii. resting pressure: assessed by pressure manometry, which measures intra-vaginal resting pressure in cmH2O, a surrogate measure of PFM resting tone
Timepoint [3] 392868 0
at each assessment time-point:
T1: baseline, before surgery
T2: 3 months after surgery
T3: 12 months after surgery
Secondary outcome [4] 392869 0
iv. pelvic floor muscle strength: assessed by digital palpation of force generated by the participant on attempt to maximally contract her PFM (measured on a 4-point scale: absent, weak, moderate, strong), a partly subjective measure
Timepoint [4] 392869 0
At each assessment time-point:
T1: baseline, before surgery
T2: 3 months after surgery
T3: 12 months after surgery
Secondary outcome [5] 394643 0
v. pelvic floor muscle strength: assessed by a pressure manometry device, which measure intra-vaginal squeeze pressure in cmH2O, an objective measure of strength
Timepoint [5] 394643 0
At each assessment time-point:
T1: T1: baseline, before surgery
T2: 3 months after surgery
T3: 12 months after surgery
Secondary outcome [6] 394644 0
Australian Pelvic Floor Questionnaire (APFQ), a patient-reported outcome measure, a validated questionnaire.
Timepoint [6] 394644 0
T1: baseline, before surgery
T2: 3 months after surgery
T3: 12 months after surgery
Secondary outcome [7] 394645 0
Central Sensitization Inventory (CSI), Part A; a patient-reported outcome measure, a validated questionnaire
Timepoint [7] 394645 0
T1: baseline, before surgery
T2: 3 months after surgery
T3: 12 months after surgery
Secondary outcome [8] 394646 0
Pelvic Pain Impact Questionnaire (PPIQ), a patient-reported outcome measure, a validated questionnaire.
Timepoint [8] 394646 0
T1: baseline, before surgery
T2: 3 months after surgery
T3: 12 months after surgery
Secondary outcome [9] 394669 0
Patient-reported Global Impression of Change (PGIC) scale, a patient-reported outcome measure, a validated scale.
Timepoint [9] 394669 0
At T3: 12 months after surgery

Eligibility
Key inclusion criteria
• Women with pelvic pain for at least 6 months duration
• Scheduled for laparoscopy for investigation of pelvic pain, with or without sonographic evidence of endometriosis
• No prior history of surgically treated endometriosis
• Agreement to not receive physiotherapy treatment for PFM dysfunction or persistent pelvic pain between baseline assessment and 3 months post-operatively.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Women who cannot have vaginal examination:
o have never had vaginal intercourse
o are unable to tolerate vaginal examination
o are un-suitable for vaginal examination
• Pregnant, lactating, or peri-/post-menopausal women
• Inability to understand and fully comprehend consent information, including non-English speaking
• Known pathology other than endometriosis or adenomyosis as likely cause of pain
• History of or planned hysterectomy

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Participant demographics, prevalence and questionnaire summary scores will be reported descriptively using means and standard deviations for continuous variables, and frequencies and percentages for categorical variables. Differences in participant demographics between women with and without endometriosis will be examined using independent t–tests or Mann-Whitney U test depending on the distribution of continuous data and ?2 tests for categorical variables. Logistic and linear regression, as appropriate to the data, will be undertaken.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2021
Actual
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
151
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18916 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 18917 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [3] 18918 0
Frances Perry House - Parkville
Recruitment hospital [4] 18919 0
Epworth Richmond - Richmond
Recruitment hospital [5] 18920 0
Epworth Freemasons (Clarendon Street) - East Melbourne
Recruitment hospital [6] 18921 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [7] 18922 0
Western Hospital - Footscray - Footscray
Recruitment hospital [8] 18923 0
Sunshine Hospital - St Albans
Recruitment hospital [9] 18924 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [10] 18925 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [11] 18926 0
Holmesglen Private Hospital - Moorabbin
Recruitment postcode(s) [1] 33421 0
3052 - Parkville
Recruitment postcode(s) [2] 33422 0
3084 - Heidelberg
Recruitment postcode(s) [3] 33423 0
3121 - Richmond
Recruitment postcode(s) [4] 33424 0
3002 - East Melbourne
Recruitment postcode(s) [5] 33425 0
3011 - Footscray
Recruitment postcode(s) [6] 33426 0
3021 - St Albans
Recruitment postcode(s) [7] 33427 0
3065 - Fitzroy
Recruitment postcode(s) [8] 33428 0
3144 - Malvern
Recruitment postcode(s) [9] 33429 0
3189 - Moorabbin

Funding & Sponsors
Funding source category [1] 308110 0
University
Name [1] 308110 0
The University of Melbourne
Country [1] 308110 0
Australia
Primary sponsor type
Government body
Name
NHMRC-MRFF
Address
NHMRC
16 Marcus Clarke St, Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 308862 0
None
Name [1] 308862 0
Address [1] 308862 0
Country [1] 308862 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308095 0
Austin Health HREC
Ethics committee address [1] 308095 0
Ethics committee country [1] 308095 0
Australia
Date submitted for ethics approval [1] 308095 0
30/11/2020
Approval date [1] 308095 0
18/01/2021
Ethics approval number [1] 308095 0
HREC/67325/Austin-2020

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

Contacts
Principal investigator
Name 109518 0
A/Prof Helena Frawley
Address 109518 0
Melbourne School of Health Sciences,
Faculty of Medicine, Dentistry & Health Sciences
Level 6, Alan Gilbert Building, 161 Barry Street
The University of Melbourne, Victoria 3010
Country 109518 0
Australia
Phone 109518 0
+61 0418584813
Fax 109518 0
Email 109518 0
h.frawley@unimelb.edu.au
Contact person for public queries
Name 109519 0
Helena Frawley
Address 109519 0
Melbourne School of Health Sciences,
Faculty of Medicine, Dentistry & Health Sciences
Level 6, Alan Gilbert Building, 161 Barry Street
The University of Melbourne, Victoria 3010
Country 109519 0
Australia
Phone 109519 0
+61 0418584813
Fax 109519 0
Email 109519 0
h.frawley@unimelb.edu.au
Contact person for scientific queries
Name 109520 0
Helena Frawley
Address 109520 0
Melbourne School of Health Sciences,
Faculty of Medicine, Dentistry & Health Sciences
Level 6, Alan Gilbert Building, 161 Barry Street
The University of Melbourne, Victoria 3010
Country 109520 0
Australia
Phone 109520 0
+61 0418584813
Fax 109520 0
Email 109520 0
h.frawley@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified participant data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
to achieve the aims in the approved proposal, and for potential IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator: h.frawley@unimelb.edu.au


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.