NCT06869538

Brief Summary

Urinary incontinence and fecal incontinence are common health problems in the postpartum period because of their effect on daily life and are likely to reduce quality of life. It is known that the most effective way to protect from UI during pregnancy and the postpartum period is pelvic floor muscle exercise. This study aimed to investigate the effects of Pilates and Kegel exercises applied during pregnancy on the quality of life of urinary and fecal incontinence in the postpartum period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2022

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

February 8, 2025

Last Update Submit

March 5, 2025

Conditions

Keywords

Urinary İncontinenceFecal İncontianceQuality Of Lifepregnancyexercise

Outcome Measures

Primary Outcomes (6)

  • Baseline Anthropometric Measurements (Weight, Height, BMI)

    Baseline meausurement ( 1 week) Participants will be evaluated at baseline. Data collection refers to anthropometric parameters (Weight, height and BMI. BMI BMI will calculated as weight in kilograms divided by height squared (kg/m2) in meters

    2021 june

  • Urinary Incontinence Quality of Life Scale (I-QOL)-Baseline and Follow-up Measurements

    Urinary Incontinence Quality of Life Scale (I-QOL) - Evaluates the quality of life related to urinary incontinence. Description: Evaluates the quality of life related to urinary incontinence. This scale was applied at baseline and at the 1st and 3rd months postpartum. Minimum Value: 0 (Poor quality of life) Maximum Value: 100 (High quality of life) Higher Scores Indicate: Better quality of life Data Aggregation: Mean ± SD and comparison of scores between groups using ANOVA.

    June 2021 (Baseline) and 1st and 3rd months postpartum

  • Effect of an 8-Week Exercise Intervention on Urinary and Fecal Incontinence - Measured by ICIQ-UI Short Form and Wexner Continence Assessment Scale

    This measure evaluates the effect of an 8-week exercise intervention on urinary and fecal incontinence in pregnant women. Urinary incontinence severity will be assessed using the ICIQ-UI SF, and fecal incontinence using the Wexner Scale at baseline, post-intervention (8 weeks), and 1st and 3rd months postpartum. Participants are divided into two groups: Pilates Group (PEG): Performed Pilates twice a week, 40 minutes per session, for 8 weeks, using a mini ball, resistance band, and Pilates ring. Kegel Group (KEG): Performed Kegel exercises 4 days a week, 3 sessions per day, for 8 weeks, involving controlled pelvic floor contractions and relaxations. Measurement Tools: Urinary Incontinence: ICIQ-UI SF Fecal Incontinence: Wexner Scale

    Baseline (June 2021), Post-intervention (August 2021), and Follow-up at 1st and 3rd months postpartum.

  • International Incontinence Questionnaire Short Form Score (ICIQ-SF) - Urinary Incontinence Impact

    Description: Assesses the impact of urinary incontinence on daily life. Minimum Value: 0 (No impact) Maximum Value: 21 (Severe impact) Higher Scores Indicate: Worse quality of life Data Aggregation: Mean ± SD and comparison of groups using repeated measures ANOVA, paired t-test for pre- and post-intervention comparison.

    2021 September 2021 November

  • Wexner Continence Assessment Scale Score - Fecal Incontinence Severity

    Description: Measures the severity of fecal incontinence. Minimum Value: 0 (Complete continence) Maximum Value: 20 (Complete incontinence) Higher Scores Indicate: Worse fecal incontinence Data Aggregation: Mean ± SD and comparison of groups using repeated measures ANOVA, paired t-test for pre- and post-intervention comparison.

    September 2021 - November 2021

  • Fecal Incontinence Quality of Life Scale (FIQL) Score

    Description: Assesses the quality of life related to fecal incontinence. Minimum Value: 1 (Poor quality of life) Maximum Value: 5 (High quality of life) Higher Scores Indicate: Better quality of life Data Aggregation: Mean ± SD and comparison of groups using repeated measures ANOVA, paired t-test for pre- and post-intervention comparison

    September 2021 - November 2021

Interventions

For the Pilates exercises, a Pilates instructor created movements (squeeze mini ball, stretch hoop, circle with large ball, back and forth with large ball, and squat) in the gymnasium of the pregnancy school for 8 weeks, 2 days a week. Auxiliary equipment (mini ball, resistance band, Pilates ring) was used. Kegel exercises were performed 4 days a week, 3 sessions a day for 8 weeks.

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly pregnancy women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnancy women

You may not qualify if:

  • Not being between the ages of 18-38,
  • Having a condition that prevents exercise,
  • Not being in the 1st and 2nd trimesters of pregnancy,
  • Leaving scale items blank, and having a cesarean section.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit University

Çorum, Central, 19030, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Nocturnal EnuresisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2025

First Posted

March 11, 2025

Study Start

June 15, 2021

Primary Completion

November 5, 2021

Study Completion

February 13, 2022

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

There is a plan to make IPD and related data dictionaries available

Shared Documents
STUDY PROTOCOL

Locations