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

Urinary Incontinence Clinical Trial

— PFMT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349736
• Other study ID #: 112/2016
• Status: Completed
• Phase: N/A
• Start date: June 25, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: May 2019
• Source: Kathmandu University School of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: April 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence

Intervention

Other:
• Pelvic Floor Muscle Training
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.

Locations

Country	Name	City	State
Nepal	Kathmandu University Dhulikhel Hospital	Kavre	Kathmandu

Sponsors (2)

Lead Sponsor	Collaborator
Kathmandu University School of Medical Sciences	University of Oslo

Country where clinical trial is conducted

Nepal, 

References & 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. — View Citation

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. Epub 2007 Mar 1. — View Citation

Boyle R, Hay-Smith EJ, Cody JD, Mørkved 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. Review. Update in: Cochrane Database Syst Rev. 2017 Dec 22;12 :CD007471. — View Citation

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. — View Citation

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,

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

KEGEL AH. Progressive resistance exercise in the functional restoration of the perineal muscles. Am J Obstet Gynecol. 1948 Aug;56(2):238-48. — View Citation

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

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

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

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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