A Comparison of Urinary Incontinence During Third Trimester of Nulliparous on Pelvic Floor Muscle Training
NCT ID: NCT04525846
Last Updated: 2020-08-25
Study Results
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Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2019-08-23
2020-06-30
Brief Summary
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Detailed Description
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1. primary outcome \>\> UI at third trimester
2. secondary outcome \>\> quality of life, duration of second stage of labor
* Inclusion criteria nulliparous GA 20-24 week gestation singleton Age 18-35 years old Can communicate and understand Thai language Cooperating to join research
* Exclusion criteria DFIU Maternal medical condition or high risk pregnancy such as multifetal gestation, chronic hypertension, pregestational DM, epilepsy, autoimmune disease, polyhydramnios asthma
* Pre-excisting urinary incontinence
* prepregnancy BMI\>=30 kg/m2
* smoking
* 2 groups study \>\> control and intervention group
* Both groups were evaluated urinary incontinence(UI) at third trimester with UDI-6 and IIQ-7 questionaires
* Intervention group was trianed pelvic floor muscle strength and evaluate strength with Brink score by researcher who was trained and tested pelvic floor muscle strength by urogynecologist at day 1 then reassess Brink score at 4 weeks
* program of pelvic floor muscle training ( PFMT) consist of contract and whole pelvic floor muscle 10 seconds and relaxation 10 second total 20 times per set total 3 set per day
* intervention group was followed up once a week by telephone about compliance of program, general symptom and notice for self recording sheet
* PFMT program follow up total 12 weeks
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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PFMT group
Researcher was trained and test pelvic floor muscle strength by urogynecologist with Brink scores, participants PFMT group were educated by VDO and recieved program of PFMT after consented form 4 weeks reassess Brink score for check compliance of PFMT and followed up by telephone weekly about compliance of PFMT, general symptom, notice self recording book total 12 weeks and evaluate urinary incontinence by UDI-6 questionaires at third trimester
PFMT
* program of PFMT consist of contract and hold pelvic floor muscle 10 seconds and relax 10 seconds 20 times per set totally 3 set per day
* follow up by telephone once a week about compliance of program PFMT, general symptoms, notice recording book
* at third trimester evaluate UI by questionaire (UDI-6, IIQ-7)
non PFMT
Randomized to non PFMT group watchful waiting until 36-38 week gestation follow up and evaluate UI by UDI6 questionaires at third trimester sames as intervention group
non PFMT
Randomized to non PFMT group follow up and evaluate UI at third trimester sames as intervention group
Interventions
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PFMT
* program of PFMT consist of contract and hold pelvic floor muscle 10 seconds and relax 10 seconds 20 times per set totally 3 set per day
* follow up by telephone once a week about compliance of program PFMT, general symptoms, notice recording book
* at third trimester evaluate UI by questionaire (UDI-6, IIQ-7)
non PFMT
Randomized to non PFMT group follow up and evaluate UI at third trimester sames as intervention group
Eligibility Criteria
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Inclusion Criteria
* gestational gae 20-24 week
* age 18-35 year
* can communicate and understand Thai language
* co-operate to join research
Exclusion Criteria
* maternal medical condition or high risk pregnancy such as multifetal gestation , pregestational DM, chonic hypertension , epilepsy, autoimmune disease, polyhydramnios, asthma
* pre-excisting urinary incontinence
* prepregnant BMI \>=30 kg/m2
* smoking
18 Years
35 Years
FEMALE
Yes
Sponsors
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Department of Medical Services Ministry of Public Health of Thailand
OTHER_GOV
Responsible Party
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Locations
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Rajavithi Hospital
Bangkok, , Thailand
Countries
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References
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Rogers RG, Ninivaggio C, Gallagher K, Borders AN, Qualls C, Leeman LM. Pelvic floor symptoms and quality of life changes during first pregnancy: a prospective cohort study. Int Urogynecol J. 2017 Nov;28(11):1701-1707. doi: 10.1007/s00192-017-3330-7. Epub 2017 Apr 17.
ICS. A Background to urinary and faecal incontinence. August 2015
Bekele A, Adefris M, Demeke S. Urinary incontinence among pregnant women, following antenatal care at University of Gondar Hospital, North West Ethiopia. BMC Pregnancy Childbirth. 2016 Oct 28;16(1):333. doi: 10.1186/s12884-016-1126-2.
Tanawattanacharoen S, Thongtawee S. Prevalence of urinary incontinence during the late third trimester and three months postpartum period in King Chulalongkorn Memorial Hospital. J Med Assoc Thai. 2013 Feb;96(2):144-9.
Niamhom S. Nursing process in caring for postpartum mothers with stress urinary incontinence. J Nurs Sci. 2009; 27(1): 22-31
Zhu L, Li L, Lang JH, Xu T. Prevalence and risk factors for peri- and postpartum urinary incontinence in primiparous women in China: a prospective longitudinal study. Int Urogynecol J. 2012 May;23(5):563-72. doi: 10.1007/s00192-011-1640-8. Epub 2012 Jan 26.
Sangsawang B, Sangsawang N. Is a 6-week supervised pelvic floor muscle exercise program effective in preventing stress urinary incontinence in late pregnancy in primigravid women?: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2016 Feb;197:103-10. doi: 10.1016/j.ejogrb.2015.11.039. Epub 2015 Dec 2.
สรวีร์ วีระโสภณ, อภิรักษ์ สันติงามกุล. การทดสอบความแม่นยำของแบบสอบถามประเมินภาวะกลั้นปัสสาวะไม่ได้ (IIQ-7 UDI-6) เมื่อแปลเป็นภาษาไทย. จุฬาลงกรณ์เวชสาร 2559; 60(4): 389-98
Kok G, Seven M, Guvenc G, Akyuz A. Urinary Incontinence in Pregnant Women: Prevalence, Associated Factors, and Its Effects on Health-Related Quality of Life. J Wound Ostomy Continence Nurs. 2016 Sep-Oct;43(5):511-6. doi: 10.1097/WON.0000000000000262.
Sangsawang B, Sangsawang N. Stress urinary incontinence in pregnant women: a review of prevalence, pathophysiology, and treatment. Int Urogynecol J. 2013 Jun;24(6):901-12. doi: 10.1007/s00192-013-2061-7. Epub 2013 Feb 23.
Okunola TO, Olubiyi OA, Omoya S, Rosiji B, Ajenifuja KO. Prevalence and risk factors for urinary incontinence in pregnancy in Ikere-Ekiti, Nigeria. Neurourol Urodyn. 2018 Nov;37(8):2710-2716. doi: 10.1002/nau.23726. Epub 2018 Jun 8.
Schreiner L, Crivelatti I, de Oliveira JM, Nygaard CC, Dos Santos TG. Systematic review of pelvic floor interventions during pregnancy. Int J Gynaecol Obstet. 2018 Oct;143(1):10-18. doi: 10.1002/ijgo.12513. Epub 2018 May 18.
Lin YH, Chang SD, Hsieh WC, Chang YL, Chueh HY, Chao AS, Liang CC. Persistent stress urinary incontinence during pregnancy and one year after delivery; its prevalence, risk factors and impact on quality of life in Taiwanese women: An observational cohort study. Taiwan J Obstet Gynecol. 2018 Jun;57(3):340-345. doi: 10.1016/j.tjog.2018.04.003.
Pelaez M, Gonzalez-Cerron S, Montejo R, Barakat R. Pelvic floor muscle training included in a pregnancy exercise program is effective in primary prevention of urinary incontinence: a randomized controlled trial. Neurourol Urodyn. 2014 Jan;33(1):67-71. doi: 10.1002/nau.22381. Epub 2013 Feb 6.
Kahyaoglu Sut H, Balkanli Kaplan P. Effect of pelvic floor muscle exercise on pelvic floor muscle activity and voiding functions during pregnancy and the postpartum period. Neurourol Urodyn. 2016 Mar;35(3):417-22. doi: 10.1002/nau.22728. Epub 2015 Feb 3.
Salvesen KA, Stafne SN, Eggebo TM, Morkved S. Does regular exercise in pregnancy influence duration of labor? A secondary analysis of a randomized controlled trial. Acta Obstet Gynecol Scand. 2014 Jan;93(1):73-9. doi: 10.1111/aogs.12260. Epub 2013 Nov 7.
Morkved S, Bo K, Schei B, Salvesen KA. Pelvic floor muscle training during pregnancy to prevent urinary incontinence: a single-blind randomized controlled trial. Obstet Gynecol. 2003 Feb;101(2):313-9. doi: 10.1016/s0029-7844(02)02711-4.
Hundley AF, Wu JM, Visco AG. A comparison of perineometer to brink score for assessment of pelvic floor muscle strength. Am J Obstet Gynecol. 2005 May;192(5):1583-91. doi: 10.1016/j.ajog.2004.11.015.
Botros S, Gandhi S, Abramov Y, Sand P, Nickolov A, Goldberg R. Normotive values for the short forms of the UDI and IIQ in community dwelling women.
Other Identifiers
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072/2562
Identifier Type: -
Identifier Source: org_study_id
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