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

Primary Purpose

Pelvic Organ Prolapse, Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Pelvic Floor Muscle Training
Sponsored by
Kathmandu University School of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pelvic Organ Prolapse focused on measuring Pelvic floor muscle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

  • Kathmandu University Dhulikhel Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pelvic Floor Muscle Training

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2017
Last Updated
May 10, 2019
Sponsor
Kathmandu University School of Medical Sciences
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT03349736
Brief Title
Pelvic Floor Muscle Training Programme in Pregnant Nepalese Women- a Feasibility Study
Acronym
PFMT
Official Title
Pelvic Floor Muscle Training Programme in Pregnant Nepalese Women- a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 25, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kathmandu University School of Medical Sciences
Collaborators
University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Urinary Incontinence
Keywords
Pelvic floor muscle

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A feasibility study including 250 women to assess the feasibility of performing PFMT in pregnant Nepalese women. The PFMT programme consisted of attending a minimum of four supervised PFMT follow-up visits after inclusion to the programme and to perform PFMT daily at home.
Masking
None (Open Label)
Allocation
N/A
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic Floor Muscle Training
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Muscle Training
Intervention Description
All the women will receive information and instruction/guidance exercise individually and in groups on PFMT on the first day of their visit. Following this, the women are advised to perform daily PFMT at home which includes 10 sec hold X 10 times X 3 sets. Women will record their home PFMT using an exercise diary. During the follow-up, women will attend the PFMT in a group or individual led by a Physiotherapists (to motivate and to ensure women are performing the PFMT correctly). Exercise diary will be collected in every follow up so that the information is retained even if the women discontinued or deviate from intervention protocols.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
21 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study will be conducted in pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pregnant women able to understand information and instructions in the Nepalese language 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Britt Stuge, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rajendra Koju, MD
Organizational Affiliation
Kathmandu University School of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Kathmandu University Dhulikhel Hospital
City
Kavre
State/Province
Kathmandu
ZIP/Postal Code
11008
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27921161
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
26664731
Citation
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Results Reference
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PubMed Identifier
22161382
Citation
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Results Reference
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PubMed Identifier
17333434
Citation
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PubMed Identifier
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Citation
Shrestha B, Onta S, Choulagai B, Poudyal A, Pahari DP, Uprety A, Petzold M, Krettek A. Women's experiences and health care-seeking practices in relation to uterine prolapse in a hill district of Nepal. BMC Womens Health. 2014 Feb 3;14:20. doi: 10.1186/1472-6874-14-20.
Results Reference
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PubMed Identifier
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Citation
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Pelvic Floor Muscle Training Programme in Pregnant Nepalese Women- a Feasibility Study

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