ANZCTR - Registration

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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

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pelvic organ prolapse

Condition category

Condition code

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Public Health

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]

Rehabilitation

Intervention code [2]

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]

Change in mean score for the validated Prolapse-Quality of Life (P-QoL) questionnaire

Timepoint [1]

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]

Frequency of performing PFMT as recorded in a daily diary

Timepoint [1]

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?

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]

Nepal

State/province [1]

Kathmandu Valley

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Delena Caagbay

Address [1]

The University of Sydney
Sydney NSW 2006

Country [1]

Australia

Funding source category [2]

University

Name [2]

Dr Albert S McKern Research Scholarship

Address [2]

Sydney Medical School
The University of Sydney
Sydney, NSW 2009

Country [2]

Australia

Primary sponsor type

Individual

Name

Delena Caagbay

Address

The University of Sydney
Sydney, NSW 2006

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Ganesh Dangal

Address [1]

Kathmandu Model Hospital
Pradarsani Marg
GPO Box: 6064
Kathmandu

Country [1]

Nepal

Secondary sponsor category [2]

Individual

Name [2]

Kirsten Black

Address [2]

The University of Sydney
Sydney NSW 2006

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Camille Raynes-Greenow

Address [3]

The University of Sydney
Sydney, NSW 2006

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Institutional Review Committee (phect-Nepal)

Ethics committee address [1]

Public Health Concern Trust
GPO Box 6064
Pradarshani Marg
Kathmandu

Ethics committee country [1]

Nepal

Date submitted for ethics approval [1]

03/10/2017

Approval date [1]

30/10/2017

Ethics approval number [1]

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

Mrs Delena Caagbay

Address

The University of Sydney
Sydney NSW 2006

Country

Australia

Phone

+61 2 9351 2222

Fax

dcaa7602@uni.sydney.edu.au

Contact person for public queries

Name

Delena Caagbay

Address

The University of Sydney
Sydney NSW 2006

Country

Australia

Phone

+61 02 9351 2222

Fax

dcaa7602@uni.sydney.edu.au

Contact person for scientific queries

Name

Delena Caagbay

Address

The University of Sydney
Sydney NSW 2006

Country

Australia

Phone

+61 02 9351 2222

Fax

dcaa7602@uni.sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Impact of an informational flipchart on lifestyle advice for Nepali women with a pelvic organ prolapse: a randomized controlled trial.	2020	https://dx.doi.org/10.1007/s00192-020-04228-1

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

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Documents added manually

Documents added automatically