A Comparison of Urinary Incontinence During Third Trimester of Nulliparous on Pelvic Floor Muscle Training

Urinary Incontinence Clinical Trial

Official title:

A Comparison of Urinary Incontinence During Third Trimester of Nulliparous on Pelvic Floor Muscle Training in Rajavithi Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525846
• Other study ID #: 072/2562
• Status: Completed
• Phase: N/A
• Start date: August 23, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of urinary incontinence during third trimester of nulliparous on pelvic floor muscle training in Rajavithi hospital

Description:

Outcomes

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 30, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• nulliparous

• gestational gae 20-24 week

• age 18-35 year

• can communicate and understand Thai language

• co-operate to join research

Exclusion Criteria:

• DFIU

• 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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Other:
• 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

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (19)

?????? ????????, ???????? ???????????. ??????????????????????????????????????????????????????????? (IIQ-7 UDI-6) ???????????????????. ???????????????? 2559; 60(4): 389-98

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. — View Citation

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.

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. — View Citation

ICS. A Background to urinary and faecal incontinence. August 2015

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. — View Citation

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. — View Citation

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 — View Citation

Mørkved S, Bø 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. — View Citation

Niamhom S. Nursing process in caring for postpartum mothers with stress urinary incontinence. J Nurs Sci. 2009; 27(1): 22-31

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. — View Citation

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 — View Citation

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 — View Citation

Salvesen KÅ, Stafne SN, Eggebø TM, Mørkved 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. — View Citation

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; — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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 2 — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary incontinence at third trimester both group	Use Questionaires Urinary Distress Inventory (UDI-6) include 6 domains( Frequency, Urgency incontinence, Stress incontinence, Drops, Emptying difficulty, Pain /discomfort each domain raw score from 0-3 (0=not at all, 1= a little bit, 2=moderately, 3=greatly) (total raw score 18 point ) define score total 100 point if at least 16.7% means urinary incontinence and below 16.7% means nornal ( continence= no UI )	GA 36-38 wk
Secondary	Quality of life at third trimester both group	Incontinence impact questionaires (IIQ-7) includes Household chores, Physical recreation, Entertainment activities, Travel ability, Social activities, Emotional health, Feeling frustrated. Each domain has raw score 0-3 (0=not at all, 1= a little bit, 2=moderately, 3=greatly), total raw score 21 points. It's defined total score 100 point if at least 70 means impact qaulity of life	GA 36-38 wk
Secondary	Duration of second stage of labor in both group	use partograph and labor record, Duration of second stage of labor define as times of cervical fully dilatation until baby delivery difine as minutes	date of delivery
Secondary	Correlation between urinary incontinence and quality of life	questionaire UDI-6 , IIQ-7 hypothesis high score of UDI6 associated poor quality of life	GA 36-38 wk

External Links

•   WHO Reproductive Health Library. WHO recommendation on definition and duration of the second stage of labour (February 2018).