Pelvic Floor Muscle Training Programme in Pregnant Nepalese Women- a Feasibility Study

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse; Urinary Incontinence
• Interventions: Other: Pelvic Floor Muscle Training

• Registration Number: NCT03349736
• Lead Sponsor: Kathmandu University School of Medical Sciences

Brief Summary

To our knowledge, no studies in Nepal have reported the feasibility of performing the pelvic floor muscle training in Nepalese women. The aim of the study is to develop and a pelvic floor muscle training programme based on information, education (leaflet, video) and pelvic floor muscles (PFM) exercise in order to prevent or reduce Pelvic organ prolapse(POP) and Urinary Incontinence (UI) in pregnant Nepalese women.

The women will receive information (leaflet, video, posters) and guidance on PFMT. Following this, the women are advised to perform daily home PFM exercise Women will record their home PFMT using an exercise diary.

Detailed Description

PFM supports the bowel, bladder, and uterus. Pelvic floor dysfunction can lead to gynecological problems like POP and UI. POP is the downward displacement of uterus from its normal anatomical position and UI is the involuntary leakage of urine.

In Nepal, the prevalence of POP is 10% in women of reproductive age and reported UI is 60% and 50.6% from two studies. POP risk factors include early marriage, high parity, squatting during delivery, prolonged labor, increasing age, menopause, hysterectomy, smoking, obesity, heavy lifting, and early return to work after parturition. High reports of POP and UI could be due to the exposure to these potential risks factors in Nepalese women. Women in Nepal play a significant role in agricultural and household work and are exposed to these risks factors daily. Studies have shown that besides longer days with work, women have less time for sleep and leisure. One of the main work-related health problems for Nepalese women is the physical effect of chronic overwork due to women's triple roles and subordinate position in the family.

The government of Nepal created a fund to provide free surgery to women with POP in 2008. Surgery is a common treatment for POP, however, 58% report an occurrence of recurrent prolapse after surgery and 29% report re-operations. PFM exercise has Level I evidence for treatment (Stage 1 \& 2) or prevention of POP. Women diagnosed with POP in Nepal, have 69.1% first-degree prolapse while the remaining 30.9% suffer from second and third-degree prolapse. Women's reluctance to seek treatment might be lack of family support, high costs for travel, food and lodging and ineffective treatment. Moreover, the health facilities are poor in rural areas as the infrastructure is weak, with few roads and commonly in poor condition which makes it more difficult. The PFM exercise does not need an instrument and can be done at home/workplace. PFM exercise for the treatment of POP (stage 1 \& 2) and UI was popularized by Kegel exercise. The use of PFM exercise is based on two functions of the PFM, support of the pelvic organs and a contribution to the sphincter closure mechanism of the urethra.

This project will investigate the feasibility of a cost-effective physiotherapy program based on information, education, and PFMT, hopefully, to help improve the health outcome of Nepalese women. The feasibility study will be essential for a future cluster randomized controlled study.

Hence, the aim is to assess the feasibility of performing PFMT in pregnant women to help prevent or reduce POP and UI in Nepal.

Study Timeline

• Study Start: 2017-06-25
• Study First Submitted: 2017-11-05
• Study First Submitted QC: 2017-11-19
• Study First Posted: 2017-11-22
• Primary Completion: 2018-03-30
• Study Completion: 2018-04-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 253

Inclusion Criteria

• pregnant women able to understand information and instructions in the Nepalese language

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Exclusion Criteria

• women with psychiatric diagnosis
• pregnancy related complications like pre-eclampsia
• risk of threatened abortion
• more than 16 weeks duration in 1st visit and
• not willing to participate or not able to communicate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pelvic Floor Muscle Training	Pelvic Floor Muscle Training	Women visiting antenatal (up to16 weeks of gestation) will be enrolled for the study. The women will be follow up 4 times during the antenatal visit until 37 weeks of gestation. Questionnaire data and clinical measurements(strength of PFM by Electromyograph biofeedback) will be registered at baseline and and follow-up at week 37 of pregnancy. The treatment program will include 1) Information, educational material (leaflets, posters, and video) and individual/group exercise on PFM exercise on the 1st day of the visit. Counseling about the importance of performing PFM exercise will be provided. Women are advised to perform home PFM exercise and record in the exercise diary.

Primary Outcome Measures

Name	Time	Method
To develop a PFMT programme and and second to assess the feasibility in terms of recruitment capability, sample characteristics, data collection procedures, outcome measures, and acceptability of the PFMT programme in pregnant Nepalese women.	21 weeks	Acceptability of the PFMT programme was assessed by attendance at supervised PFMT hospital visits, adherence to daily PFMT, and participant experiences of attending the programme.

Trial Locations

Locations (1)

Kathmandu University Dhulikhel Hospital; 🇳🇵 Kavre, Kathmandu, Nepal