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Urinary IncontinenceNCT04525846

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

A study testing PFMT and non PFMT in people with Urinary Incontinence, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Comparison of urinary incontinence during third trimester of nulliparous on pelvic floor muscle training in Rajavithi hospital Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Urinary Incontinence
What is being tested?
PFMT and non PFMT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteThailand
Study dates
23 Aug 2019to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Rajavithi Hospital

    Bangkok, 10400

Other trials in Thailand

About this study

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

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

Read the detailed 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
Being tested
PFMT, non PFMT
Keywords
urinary incontinence, pelvic floor muscle training, nulliparous, pregnancy
Medical subject headings
Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PFMTOther

    • 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 PFMTOther

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

Study groups in NCT04525846
Study groupRoleWhat they receive
PFMT groupExperimentalResearcher 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
Receives: Other: PFMT
non PFMTExperimentalRandomized 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
Receives: Other: non PFMT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 )

    Measured: GA 36-38 wk

Secondary outcomes (3)

  1. 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

    Measured: GA 36-38 wk

  2. 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

    Measured: date of delivery

  3. Correlation between urinary incontinence and quality of life

    questionaire UDI-6 , IIQ-7 hypothesis high score of UDI6 associated poor quality of life

    Measured: GA 36-38 wk

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2020
  2. Study start23 Aug 2019
  3. Primary completion31 May 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04525846
Sponsor's protocol ID
072/2562
Status last verified
Aug 2020
First submitted
10 Sep 2019
Last updated
25 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28417155

  • 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.

    PubMed 27793178

  • 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.

    PubMed 23936978

  • 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.

    PubMed 22278711

  • 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.

    PubMed 26720598

  • 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.

    PubMed 27607747

  • 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.

    PubMed 23436035

  • 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.

    PubMed 29882369

  • 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.

    PubMed 29705985

  • 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.

    PubMed 29880161

  • 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.

    PubMed 23389863

  • 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.

    PubMed 25648223

Questions about this trial

What is this clinical trial studying?

A study testing PFMT and non PFMT in people with Urinary Incontinence, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary incontinence at third trimester both group (time frame: GA 36-38 wk). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04525846, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.

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