Clinical trial NCT03349736: Pelvic Floor Muscle Training Programme in Pregnant Nepalese Women- a Feasibility Study
Official title: Pelvic Floor Muscle Training Programme in Pregnant Nepalese Women- a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Urinary Incontinence
Keywords: Pelvic floor muscle
Lead sponsor: Kathmandu University School of Medical Sciences
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2017-11-22
Enrollment: 253
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 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.
timeFrame: 21 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kavre
country: Nepal
facility: Kathmandu University Dhulikhel Hospital
state: Kathmandu
Study officials:
affiliation: Oslo University Hospital
name: Britt Stuge, PhD
role: STUDY_DIRECTOR
affiliation: Kathmandu University School of Medical Sciences
name: Rajendra Koju, MD
role: STUDY_CHAIR
References:
citation: 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.
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,
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.
citation: 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
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
citation: 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
citation: 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.
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. doi: 10.1007/s00192-007-0331-y. Epub 2007 Mar 1.
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.
citation: 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.
citation: 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.