Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000011280
Ethics application status
Approved
Date submitted
27/11/2017
Date registered
10/01/2018
Date last updated
27/11/2019
Date data sharing statement initially provided
19/12/2018
Date results information initially provided
19/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can an informational flip chart on pelvic floor muscle training and lifestyle advice improve the quality of life for Nepali women with a pelvic organ prolapse? A randomised control trial
Scientific title
Impact of an informational flip chart on conservative treatment strategies for Nepali women with a pelvic organ prolapse: a randomised control trial
Secondary ID [1] 293322 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic organ prolapse 305414 0
Condition category
Condition code
Reproductive Health and Childbirth 304692 304692 0 0
Other reproductive health and childbirth disorders
Public Health 304693 304693 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention includes brief verbal instruction on how to perform pelvic floor muscle training and in-depth education using a flip chart. The brief verbal instruction will be administered by the gynaecologist and the flip chart will be administered by a public health worker. The flip chart was designed specifically for this study as a resource for health workers and is not intended for the participant to take home. The flip chart describes lifestyle factors that reduce pressure on the pelvic organs such as how to reduce constipation, manage a chronic cough, correct toilet habits, weight management advice and correct lifting techniques and also describes pelvic floor muscle training in detail . The participants will be instructed to perform daily pelvic floor muscle training and to document the exercises they perform on a log sheet. The pelvic floor muscle training prescription includes performing 10 strong squeezes on and off quickly and one 10 second hold with moderate squeeze pressure. These two exercises will be performed once per day and should only take a few minutes. The intervention will take place in an outpatient gynaecology clinic in Kathmandu and will be provided individually, face to face, once only and will take 15 minutes.
Intervention code [1] 299579 0
Rehabilitation
Intervention code [2] 299773 0
Treatment: Other
Comparator / control treatment
The control group will receive usual care, which is brief (<5 minute) verbal instruction on how to perform pelvic floor muscle training. The brief verbal instruction will be administered by the gynaecologist. The participants will be instructed to perform the same pelvic floor muscle training prescription as the intervention group and to document the exercises they perform on a log sheet.
Control group
Active

Outcomes
Primary outcome [1] 303904 0
Change in mean score for the validated Prolapse-Quality of Life (P-QoL) questionnaire
Timepoint [1] 303904 0
The P-QoL will be administered at 6 weeks, 12 weeks and 6 months after the intervention. The primary endpoint will be at 6 months.
Secondary outcome [1] 340403 0
Frequency of performing PFMT as recorded in a daily diary
Timepoint [1] 340403 0
6 weeks, 12 weeks and 6 months after intervention

Eligibility
Key inclusion criteria
Women attending POP screening camps at two urban hospitals in Kathmandu Valley with a symptomatic pelvic organ prolapse stage I-III (as measured using the Pelvic Organ Prolapse Quantification System - POP-Q) are eligible for this study
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are pregnant, breastfeeding, have had gynaecological cancer, mental illness, have a stage IV POP and those who have been previously taught PFMT

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming a difference of 20% in the PQoL scores between the intervention and the control arm at 6 months follow-up, with alpha set at 0.05, and beta at 80, we estimate that we require a sample size of 64 women in each arm. To allow for loss to follow-up we have inflated the sample by ~10% to 70 women in each arm.

For statistical analysis, SPSS software will be used to compare the change in P-QoL scores between groups and identify any associations with the participant POP-Q stage, pelvic floor muscle strength, age, parity, occupation and body mass index

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2018
Actual
21/01/2018
Date of last participant enrolment
Anticipated
1/04/2018
Actual
4/12/2018
Date of last data collection
Anticipated
18/06/2019
Actual
4/06/2019
Sample size
Target
140
Accrual to date
Final
140
Recruitment outside Australia
Country [1] 9345 0
Nepal
State/province [1] 9345 0
Kathmandu Valley

Funding & Sponsors
Funding source category [1] 297945 0
Self funded/Unfunded
Name [1] 297945 0
Delena Caagbay
Country [1] 297945 0
Australia
Funding source category [2] 298370 0
University
Name [2] 298370 0
Dr Albert S McKern Research Scholarship
Country [2] 298370 0
Australia
Primary sponsor type
Individual
Name
Delena Caagbay
Address
The University of Sydney
Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 297008 0
Individual
Name [1] 297008 0
Ganesh Dangal
Address [1] 297008 0
Kathmandu Model Hospital
Pradarsani Marg
GPO Box: 6064
Kathmandu
Country [1] 297008 0
Nepal
Secondary sponsor category [2] 297036 0
Individual
Name [2] 297036 0
Kirsten Black
Address [2] 297036 0
The University of Sydney
Sydney NSW 2006
Country [2] 297036 0
Australia
Secondary sponsor category [3] 297037 0
Individual
Name [3] 297037 0
Camille Raynes-Greenow
Address [3] 297037 0
The University of Sydney
Sydney, NSW 2006
Country [3] 297037 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298990 0
Institutional Review Committee (phect-Nepal)
Ethics committee address [1] 298990 0
Public Health Concern Trust
GPO Box 6064
Pradarshani Marg
Kathmandu
Ethics committee country [1] 298990 0
Nepal
Date submitted for ethics approval [1] 298990 0
03/10/2017
Approval date [1] 298990 0
30/10/2017
Ethics approval number [1] 298990 0

Summary
Brief summary
The aim of this study is to determine if an informational flip chart describing pelvic floor muscle training (PFMT) and lifestyle advice can improve the quality of life (QOL) for Nepali women who have a symptomatic pelvic organ prolapse (POP).

In Nepal, there is a high prevalence of POP and many women have difficulties accessing treatment options. Pelvic floor muscle training has been shown to be an effective conservative treatment option for women with stage I-III POP. Many of the randomised control trials highlighting the efficacy of PFMT are based in developed countries with well-educated Caucasian women. Additionally, the protocols require participants to engage in multiple treatment sessions with a health professional. These study designs are not feasible for women living in rural regions of Nepal as often they have low literacy levels and face barriers in accessing health professionals. In these regions, local health workers are responsible for delivering maternal health information to women in the community. The current conservative approach for Nepali women with a POP involves brief (<5 minute) verbal instruction on PFMT without any additional lifestyle advice. Previous studies have shown that brief verbal instruction is often inadequate in teaching women about important lifestyle modifications and to correctly perform PFMT. In order to address these challenges, we developed a flip chart to assist local health workers in delivering in-depth education on PFMT and lifestyle advice for Nepali women who have a POP.

We hypothesise that a flip chart with in-depth information on PFMT and lifestyle advice on how to manage a POP will result in greater improvement in the Prolapse-quality of life (P-QoL) score when compared to brief verbal education on PFMT.

The study design is a randomised control trial with two arms, an intervention and a control arm. Participants include women from rural regions in Nepal attending POP screening camps at two urban hospitals in Kathmandu valley. Women with a stage I-III POP as assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system will be invited to participate in the study.

The intervention arm will be shown a flip chart with in-depth information about PFMT and lifestyle advice in addition to usual care. The control arm will receive usual care, which includes brief (<5 minute) verbal PFMT instruction only. Women in both arms will be instructed to perform PFMT daily and to document the exercises they perform on a log sheet. A prolapse quality of life questionnaire (P-QoL) will be completed at baseline then again at six, 12 weeks and 6 months post-intervention.

The results of this study will determine if an informational flip chart on PFMT and lifestyle advice may be a useful tool for local health workers to utilise when providing education to Nepali women who have a POP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78914 0
Mrs Delena Caagbay
Address 78914 0
The University of Sydney
Sydney NSW 2006
Country 78914 0
Australia
Phone 78914 0
+61 2 9351 2222
Fax 78914 0
Email 78914 0
[email protected]
Contact person for public queries
Name 78915 0
Mrs Delena Caagbay
Address 78915 0
The University of Sydney
Sydney NSW 2006
Country 78915 0
Australia
Phone 78915 0
+61 02 9351 2222
Fax 78915 0
Email 78915 0
[email protected]
Contact person for scientific queries
Name 78916 0
Mrs Delena Caagbay
Address 78916 0
The University of Sydney
Sydney NSW 2006
Country 78916 0
Australia
Phone 78916 0
+61 02 9351 2222
Fax 78916 0
Email 78916 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
SourceTitleYear of PublicationDOI
EmbaseImpact of an informational flipchart on lifestyle advice for Nepali women with a pelvic organ prolapse: a randomized controlled trial.2020https://dx.doi.org/10.1007/s00192-020-04228-1
N.B. These documents automatically identified may not have been verified by the study sponsor.