NCT07387640

Brief Summary

This study aims to investigate whether co-activation of the pelvic floor and core muscles improves treatment outcomes in individuals with urinary incontinence. Participants diagnosed with stress, or mixed urinary incontinence will undergo a 12-week pelvic floor physiotherapy program, with or without additional core muscle co-activation exercises. Changes in urinary incontinence severity, pelvic floor muscle function, core muscle activation, and quality of life will be evaluated.

Trial Health

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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress46%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

January 28, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

January 28, 2026

Last Update Submit

February 4, 2026

Conditions

Urinary Incontinence,StressStress Urinary IncontinenceUrinary IncontinenceMixed Incontinence Due to Prolapse of Female Genital Organ

Keywords

Pelvic floor muscle trainingCore stability exercisesCore Muscle Co-activationPelvic floor physiotherapySurface Electromyography

Outcome Measures

Primary Outcomes (1)

  • International Consultation on Incontinence Questionnaire

    This is a brief patient-reported questionnaire used to assess the frequency, severity, and impact of urinary incontinence on quality of life. Minimum Score: 0 Maximum Score: 21 Interpretation: Higher scores indicate worse symptoms and a greater impact on quality of life. Breakdown: The score is the sum of three items: frequency (0-5), amount (0-6), and interference with everyday life (0-10).

    12 weeks

Secondary Outcomes (4)

  • PERFECT scheme

    12 weeks

  • Surface electromyography

    12 weeks

  • Urogenital Distress Inventory (UDI-6)

    12 weeks

  • the Incontinence Impact Questionnaire (IIQ-7)

    12 weeks

Study Arms (2)

Pelvic floor muscle training

ACTIVE COMPARATOR

Participants will receive conventional pelvic floor muscle training for 12 weeks, at least three days per week

Other: Conventional Pelvic Floor Muscle Training

Synchronized Core-Pelvic Floor Muscle Training

EXPERIMENTAL

Participants will receive pelvic floor muscle training combined with co-activation exercises targeting core muscles for 12 weeks at least three days per week

Other: Pelvic Floor and Core Muscle Co-activation Training

Interventions

Conventional Pelvic Floor Muscle TrainingOTHER

Participants will receive conventional pelvic floor muscle training based on standardized pelvic floor physiotherapy principles. Exercises will be performed for 12 weeks, at least three days per week, including one supervised session and two home-based sessions.

Pelvic floor muscle training
Pelvic Floor and Core Muscle Co-activation TrainingOTHER

Participants will receive pelvic floor muscle training combined with co-activation exercises targeting core muscles. The program will be conducted for 12 weeks with the same frequency and supervision structure as the control group.

Synchronized Core-Pelvic Floor Muscle Training

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBeing women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 65 years
  • Diagnosed with stress, urge, or mixed urinary incontinence
  • Pelvic floor muscle strength grade ≥ 3 according to the Modified Oxford Scale
  • At least one episode of urinary leakage within the last month

You may not qualify if:

  • Pregnancy
  • Childbirth within the previous 6 weeks
  • Severe pelvic organ prolapse
  • Active vaginal or urinary tract infection
  • Presence of neurological or psychiatric disorders
  • Malignancy
  • Inability to cooperate with assessments or interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

  • Betül Çınar

    Bezmialem.edu.tr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Betül Çınar

CONTACT

+902125232288betulbirik@gmail.com

Betul Çınar

CONTACT

+902125232288bcinar@bezmialem.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, PhD

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 4, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)