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

NCT03349736 | Completed DMC

• 1 other identifier: 112/2016
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse; Urinary Incontinence

Keywords

Pelvic floor muscle

Outcome Measures

Primary Outcomes (1)

• 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.

  21 weeks

Study Arms (1)

Pelvic Floor Muscle Training

OTHER

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.

Other: Pelvic Floor Muscle Training

Interventions

Pelvic Floor Muscle Training OTHER

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.

Pelvic Floor Muscle Training

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study will be conducted in pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead
• University of Oslo: collaborator

Study Sites (1)

Kathmandu University Dhulikhel Hospital

Kavre, Kathmandu, 11008, Nepal

Location

Related Publications (11)

• Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017 Feb;28(2):191-213. doi: 10.1007/s00192-016-3123-4. Epub 2016 Dec 5.

  PMID: 27921161 BACKGROUND

• Gurung G, Rana A, Amatya A, Bista KD, Joshi AB, Sayami J. Pelvic organ prolapse in rural Nepalese women of reproductive age groups:What makes it so common? Nepal Journal of Obstetrics and Gynaecology 2(2):35-41, 2007,

  BACKGROUND

• Fitchett JR, Bhatta S, Sherpa TY, Malla BS, A Fitchett EJ, Samen A, Kristensen S. Non-surgical interventions for pelvic organ prolapse in rural Nepal: a prospective monitoring and evaluation study. JRSM Open. 2015 Nov 3;6(12):2054270415608117. doi: 10.1177/2054270415608117. eCollection 2015 Dec.

  PMID: 26664731 BACKGROUND

• Regmi M, Uprety D, Poonam M. Prevalence of urinary incontinence among gynecological admissions at tertiary care hospital in eastern Nepal. Health Renaissance 10(1):16-9, 2012

  BACKGROUND

• Pradhan A, Shrestha N. Working hour and its impact on backache from gender perspective. Dhaulagiri Journal of Sociology and Anthropology 4:235-46,2010

  BACKGROUND

• Shrestha A, Lakhey B, Sharma J, Singh M, Shrestha B, Singh S. Prevalence of uterine prolapse amongst gynecology OPD patients in Tribhuwan university teaching hospital in Nepal and its socio-cultural determinants. Res Cent Women. 2009

  BACKGROUND

• Hagen S, Stark D. Conservative prevention and management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2011 Dec 7;2011(12):CD003882. doi: 10.1002/14651858.CD003882.pub4.

  PMID: 22161382 BACKGROUND

• Bodner-Adler B, Shrivastava C, Bodner K. Risk factors for uterine prolapse in Nepal. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Nov;18(11):1343-6. doi: 10.1007/s00192-007-0331-y. Epub 2007 Mar 1.

  PMID: 17333434 BACKGROUND

• 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.

  PMID: 24490616 BACKGROUND

• Boyle R, Hay-Smith EJ, Cody JD, Morkved S. Pelvic floor muscle training for prevention and treatment of urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2012 Oct 17;10:CD007471. doi: 10.1002/14651858.CD007471.pub2.

  PMID: 23076935 BACKGROUND

• KEGEL AH. Progressive resistance exercise in the functional restoration of the perineal muscles. Am J Obstet Gynecol. 1948 Aug;56(2):238-48. doi: 10.1016/0002-9378(48)90266-x. No abstract available.

  PMID: 18877152 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• Britt Stuge, PhD

  Oslo University Hospital

  STUDY DIRECTOR

• Rajendra Koju, MD

  Kathmandu University School of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapists,PT,MSc

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2017
• First Posted: November 22, 2017
• Study Start: June 25, 2017
• Primary Completion: March 30, 2018
• Study Completion: April 30, 2018
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)