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

• Register: ANZCTR
• Last refreshed on: 10 December 2019
• Main ID: ACTRN12618000011280
• Date of registration: 10/01/2018
• Prospective Registration: Yes
• Primary sponsor: Delena Caagbay
• 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
• Date of first enrolment: 21/01/2018
• Target sample size: 140
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000011280.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Nepal

Contacts

• Name: Mrs Delena Caagbay

• Name: Mrs Delena Caagbay

Key inclusion & exclusion criteria

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
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

Age minimum: 18 Years
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

Public Health - Health promotion/education

Pelvic organ prolapse;
Pelvic organ prolapse

Intervention(s)

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.

Primary Outcome(s)

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

Frequency of performing PFMT as recorded in a daily diary[6 weeks, 12 weeks and 6 months after intervention]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Delena Caagbay

Dr Albert S McKern Research Scholarship

Secondary Sponsor(s)

Kirsten Black

Camille Raynes-Greenow

Ganesh Dangal

Ethics review

Status: Approved
Approval date:
Contact:

Institutional Review Committee (phect-Nepal)

Results

• Results available: Yes
• Date Posted: 19/12/2018
• Date Completed: 04/06/2019