None listed
Conditions
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.
Interventions
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 pel
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.
Sponsors
Delena Caagbay
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed