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

NCT04525846 | Completed

• 1 other identifier: 072/2562
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Incontinence

Keywords

urinary incontinence; pelvic floor muscle training; nulliparous; pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of life at third trimester both group

  GA 36-38 wk

• Duration of second stage of labor in both group

  date of delivery

• Correlation between urinary incontinence and quality of life

  GA 36-38 wk

Study Arms (2)

PFMT group

EXPERIMENTAL

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

Other: PFMT

non PFMT

EXPERIMENTAL

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

Other: non PFMT

Interventions

PFMT OTHER

* 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)

PFMT group

non PFMT OTHER

Randomized to non PFMT group follow up and evaluate UI at third trimester sames as intervention group

non PFMT

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• nulliparous
• gestational gae 20-24 week
• age 18-35 year
• can communicate and understand Thai language
• co-operate to join research

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Related Publications (19)

• 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.

  PMID: 28417155 RESULT

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

  RESULT

• 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.

  PMID: 27793178 RESULT

• 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.

  PMID: 23936978 RESULT

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

  RESULT

• 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.

  PMID: 22278711 RESULT

• 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.

  PMID: 26720598 RESULT

• สรวีร์ วีระโสภณ, อภิรักษ์ สันติงามกุล. การทดสอบความแม่นยำของแบบสอบถามประเมินภาวะกลั้นปัสสาวะไม่ได้ (IIQ-7 UDI-6) เมื่อแปลเป็นภาษาไทย. จุฬาลงกรณ์เวชสาร 2559; 60(4): 389-98

  RESULT

• 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.

  PMID: 27607747 RESULT

• 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.

  PMID: 23436035 RESULT

• 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.

  PMID: 29882369 RESULT

• 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.

  PMID: 29705985 RESULT

• 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.

  PMID: 29880161 RESULT

• 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.

  PMID: 23389863 RESULT

• 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.

  PMID: 25648223 RESULT

• 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.

  PMID: 24102423 RESULT

• 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.

  PMID: 12576255 RESULT

• 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.

  PMID: 15902162 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: To compare urinary incontinence, qaulity of life, duration of second stage of labor between pelvic floor muscle training(PFMT) group and nonPFMT group Researcher assess pelvic floor muscle strength by Brink score who verified by urogynecologist , given PFMT program and VDO education, follow up by telephone for compliance, and reassess pelvic floor muscle strength at 4 weeks after consented

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: August 25, 2020
• Study Start: August 23, 2019
• Primary Completion: May 31, 2020
• Study Completion: June 30, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)