NCT05437666

Brief Summary

The aim of this study is to investigate the effects of pelvic floor health education program on urinary incontinence symptoms, knowledge level and quality of life in women with stress urinary incontinence.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

June 27, 2022

Last Update Submit

June 27, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of urinary incontinence symptoms

    International Consultation on Incontinence Questionnaire-Short Form will be used to evaluate the urinary incontinence symptoms. The scale has 6 questions and 4 dimensions (frequency, severity, type of urinary incontinence, and its effect on daily life). The score to be obtained from the scale varies between "0" and "21". As the score increases, the urinary incontinence symptoms also increases.

    change from baseline at 6 weeks

Secondary Outcomes (4)

  • Pelvic floor health knowledge level

    change from baseline at 6 weeks

  • Urinary incontinence konwledge level

    change from baseline at 6 weeks

  • Life quality

    change from baseline at 6 weeks

  • Compliance with the program

    after program (6th week)

Study Arms (2)

Education group

EXPERIMENTAL

The education program was given both an educational presentation and a booklet related to the pelvic floor health

Other: Education and booklet

Control group

OTHER

The control group will be given a booklet related to the pelvic floor health

Other: Booklet

Interventions

The education program was given both an educational presentation accompanied by a physiotherapist once a week for six weeks and a booklet related to the pelvic floor health (pelvic floor, urinary incontinence, risk factors, treatment options, healthy behavioral strategies etc.)

Education group
BookletOTHER

The control group will be given a booklet related to the pelvic floor health (pelvic floor, urinary incontinence, risk factors, treatment options, healthy behavioral strategies etc.)

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with stress urinary incontinence
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between the ages of 18-65
  • Women with stress urinary incontinence
  • Those who volunteered to participate in the study
  • Being literate

You may not qualify if:

  • Having advanced pelvic organ prolapse
  • Having a malignancy
  • Having a urinary tract infection
  • Those who have a problem that interferes with cooperation and understanding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Seyda Toprak Celenay

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 27, 2022

First Posted

June 29, 2022

Study Start

July 15, 2022

Primary Completion

October 15, 2022

Study Completion

July 15, 2023

Last Updated

June 29, 2022

Record last verified: 2022-06