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Trial registered on ANZCTR


Registration number
ACTRN12620001182987
Ethics application status
Approved
Date submitted
7/09/2020
Date registered
9/11/2020
Date last updated
29/10/2021
Date data sharing statement initially provided
9/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Pelvic floor muscle tenderness in patient's undergoing endometriosis surgery.
Scientific title
Pelvic floor muscle tenderness in women undergoing surgery for endometriosis: investigating inter-rater reliability of gynaecologist vs. physiotherapist assessments
Secondary ID [1] 302248 0
Nil known
Universal Trial Number (UTN)
U1111-1258-0524
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 318964 0
Persistent pelvic pain 318965 0
Pelvic floor muscle dysfunction 318966 0
Condition category
Condition code
Reproductive Health and Childbirth 316934 316934 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
Patient's booked to undergo laparoscopy for investigation of persistent pelvic pain will be asked to have their pelvic floor muscle (PFM) tone and tenderness assessed pre-operatively. A digital examination of the PFM will be performed by a gynaecologist and a physiotherapist and the inter-rater reliability determined. These assessments by the gynaecologist and physiotherapist will be performed sequentially in the same visit. The physiotherapist will also use algometry devices to objectively assess the PFM tone and tenderness. These assessments are not part of standard pre-operative care and will only be performed in participants who consent to participate in the study. Participants will be observed during a single study visit of no more than 90 minutes with no further observation. At the conclusion of this visit they will be asked to complete a short questionnaire regarding their participation which has been designed specifically for this study. The questionnaire will take approximately 5 minutes to complete.
Intervention code [1] 318536 0
Diagnosis / Prognosis
Comparator / control treatment
Physiotherapist- digital examination of pelvic floor muscle tenderness
Control group
Active

Outcomes
Primary outcome [1] 325038 0
To determine the inter-rater reliability of gynaecology and physiotherapy measurements of PFM tenderness using digital palpation
Timepoint [1] 325038 0
At one observation session any time up to 3 months pre-laparoscopic procedure
Secondary outcome [1] 386620 0
To determine the inter-rater reliability of gynaecology and physiotherapy measurements of PFM tone using digital palpation
Timepoint [1] 386620 0
At one observation session any time up to 3 months pre-laparoscopic procedure
Secondary outcome [2] 386621 0
To assess the feasibility of the protocol. This will be assessed by a composite outcome incorporating the following:
o coverage: the proportion of the eligible participants who are recruited. Data will be obtained from medical records and research consent forms.
o acceptability of the assessment protocol to participants. Data will be obtained from participant questionnaires following the pre-operative assessment using questionnaires with 7-point Likert scale response items.
o recording of any adverse events-e.g pain or distress from the examination or use of algometry devices. This will be assessed using the study-specific questionnaire.
o the time, equipment and training required for the assessors. Data will be obtained from log books kept by research team.
Timepoint [2] 386621 0
At one observation session any time up to 3 months pre-laparoscopic procedure
Secondary outcome [3] 386622 0
To assess the prevalence and severity of PFM tenderness in women with and without a diagnosis of endometriosis. Tenderness will be assessed using the Tekscan algometry device
Timepoint [3] 386622 0
At one observation session any time up to 3 months pre-laparoscopic procedure
Secondary outcome [4] 386623 0
To assess PFM resting tone
o PFM resting tone will be assessed using digital palpation and a pressure manometry device. Femfit® is a new intravaginal pressure manometry device that is easy to use and has established reliability and validity
Timepoint [4] 386623 0
At one observation session any time up to 3 months pre-laparoscopic procedure
Secondary outcome [5] 386624 0
To compare findings of PFM resting tone recorded during digital examination to findings from objective measures with the Tekscan and Femfit devices.
Timepoint [5] 386624 0
At one observation session any time up to 3 months pre-laparoscopic procedure
Secondary outcome [6] 387697 0
To assess PFM active contraction
- PFM active contraction will be assessed using digital palpation and the Femfit® manometry device
Timepoint [6] 387697 0
At one observation session any time up to 3 months pre-laparoscopic procedure
Secondary outcome [7] 387698 0
To compare findings of PFM active contraction recorded during digital examination to findings from objective measures with the Tekscan and Femfit devices.
Timepoint [7] 387698 0
At one observation session any time up to 3 months pre-laparoscopic procedure

Eligibility
Key inclusion criteria
• Women aged 18-50
• Pelvic pain for equal-to or more-than 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Inability to understand and fully comprehend consent information
• Known pathology other than endometriosis or adenomyosis as likely cause of pain
• History of or planned hysterectomy
• Non-English speakers

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Due to feasibility and time, the total possible sample size is 30 participants. Each participant will have four sites assessed for tenderness, thus resulting in 120 observations per rater. Two raters (one gynaecologist and one physiotherapist) will assess each of the four sites for each participant. Inter-rater reliability will be determined using the intra-class correlation (ICC); an ICC of 0.7-0.8 was assumed between tenderness ratings for each rater. As the correlation between sites within an individual is unknown, this was allowed to vary from 0.5 (best case scenario) to 1 (worst case scenario). This provides a design effect of 2.5 in the first instance and a design effect of 4 in the second. Sample size calculations were conducted based on precision to ensure that the lower limit of a 95% one-sided confidence limit for the ICC is no less than a pre-specified value. In the worst-case scenario, a sample size of 30 and ICC of 0.75 provides 80% power to ensure that the lower limit of a 95% one-sided confidence limit for the ICC is no less than 0.63. This study aims to have sufficient power to ensure a lower limit of at least 0.50 to ensure moderate agreement between gynaecologist and physiotherapist ratings.

Inter-rater reliability in PFM tenderness using digital assessment between gynaecologists and physiotherapists will be measured using the intra-class correlation coefficient (ICC), assessing consistency in rating rather than absolute agreement. The ICC between raters will be estimated using mixed models accounting for site and participant. As it is of particular importance that gynaecologists and physiotherapists are able to distinguish between those that do and do not have tenderness problems, in secondary analyses, the ICC between raters ability to correctly classify those who have any PFM tenderness (no/yes) will also be estimated using mixed models accounting for site and participant, with absolute agreement the focus of this assessment.
Furthermore, in secondary analyses, the inter-rater reliability of gynaecologist and physiotherapist measurements of PFM tone using digital assessment will be measured using the ICC, assessing consistency, using mixed models accounting for site and participant.

The prevalence of participants reporting any PFM tenderness (no/yes) as measured using a pressure algometry device will be reported, as well as the severity of PFM tenderness for those who report tenderness on a scale of 1-10. The prevalence of participants reporting PFM resting tone of normal, decreased or increased tone and active contraction of absent, weak, moderate or strong, measured using digital palpation and a pressure manometry device, will also be reported.
Protocol feasibility will be assessed by examining descriptive characteristics of coverage, acceptability, adverse events and assessor time, equipment and training. The proportion of eligible participants who are recruited will be reported as an assessment of coverage. Acceptability of the assessment components will be evaluated by using a questionnaire with 7-point Likert scale response to questions of ‘how acceptable did you find the pelvic floor muscle assessments used in this study?’, ‘how acceptable did you find the questionnaires used in this study?’, and any adverse events.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/12/2020
Actual
19/05/2021
Date of last participant enrolment
Anticipated
24/12/2021
Actual
Date of last data collection
Anticipated
24/12/2021
Actual
Sample size
Target
30
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17449 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 17450 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 31177 0
3052 - Parkville
Recruitment postcode(s) [2] 31178 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 306669 0
Hospital
Name [1] 306669 0
The Royal Women's Hospital
Country [1] 306669 0
Australia
Primary sponsor type
Individual
Name
Keryn Harlow
Address
Gynaecology 2 Unit
The Royal Women's Hospital
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 307220 0
Hospital
Name [1] 307220 0
The Royal Women's Hospital
Address [1] 307220 0
The Royal Women's Hospital
Parkville
Victoria 3052
Country [1] 307220 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306849 0
The Royal Women's Hospital Research and Ethics Committee
Ethics committee address [1] 306849 0
Ethics committee country [1] 306849 0
Australia
Date submitted for ethics approval [1] 306849 0
Approval date [1] 306849 0
10/06/2020
Ethics approval number [1] 306849 0
RWH 62469

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

Contacts
Principal investigator
Name 105222 0
Dr Keryn Harlow
Address 105222 0
Gynaecology 2 Unit
The Royal Women's Hospital
Parkville
Victoria 3052
Country 105222 0
Australia
Phone 105222 0
+61449726564
Fax 105222 0
Email 105222 0
[email protected]
Contact person for public queries
Name 105223 0
Keryn Harlow
Address 105223 0
Gynaecology 2 Unit
The Royal Women's Hospital
Parkville
Victoria 3052
Country 105223 0
Australia
Phone 105223 0
+61449726564
Fax 105223 0
Email 105223 0
[email protected]
Contact person for scientific queries
Name 105224 0
Keryn Harlow
Address 105224 0
Gynaecology 2 Unit
The Royal Women's Hospital
Parkville
Victoria 3052
Country 105224 0
Australia
Phone 105224 0
+61449726564
Fax 105224 0
Email 105224 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.