NCT07693920

Brief Summary

The aim of this study is to investigate the effects of expiratory muscle strength training in addition to pelvic floor muscle training in women with stress urinary incontinence. In this study, women will be randomly assigned to one of two separate intervention groups. One group is the Pelvic Floor Muscle Training (PFMT) group, and the other is the PFMT plus Expiratory Muscle Strength Training group. The intervention program will last 8 weeks in both groups. Women in both groups will be evaluated at the beginning of the study (before the interventions) and at the end of the 8th week of intervention. After being taught the exercises included in the PFMT program, both groups will be asked to perform these exercises as a home program. The accuracy of the exercises performed by the women will be checked at two-week intervals, and the number of exercises will be increased. The primary outcome measure is the International Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF), which measures the Subjective Severity of Incontinence and its Impact on Daily Living.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jul 2026

Shorter than P25 for not_applicable

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 Progress11%
Jul 2026Feb 2027

First Submitted

Initial submission to the registry

July 5, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

July 7, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2027

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 5, 2026

Last Update Submit

July 5, 2026

Conditions

Keywords

stress urinary incontinencewomenpelvic floor muscle trainingExpiratory muscle strength training

Outcome Measures

Primary Outcomes (1)

  • International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form

    The subjective severity of incontinence and its impact on daily life will be assessed using the International Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF).

    Baseline and after 8 weeks of intervention.

Secondary Outcomes (4)

  • Respiratory Muscle Strength Assessment

    Baseline and 8 weeks

  • Pelvic Floor Muscle Strength

    Baseline and 8 weeks

  • Objective incontinence severity

    Baseline and 8 weeks

  • Patient Global Change (Improvement) Perception Scale

    In week 8

Study Arms (2)

Pelvic Floor Muscle Training

EXPERIMENTAL

Women will receive a pelvic floor muscle training program.

Behavioral: Pelvic Floor Muscle Training

Pelvic Floor Muscle Training plus Expiratory Muscle Strength Training

EXPERIMENTAL

Participants will receive pelvic floor muscle training combined with Expiratory Muscle Strength Training.

Behavioral: Pelvic Floor Muscle TrainingBehavioral: Expiratory muscle strength training

Interventions

As part of the PTKE program, women will be taught rapid-maximal isolated contractions and multiple-repeated submaximal isolated contractions via vaginal palpation.

Pelvic Floor Muscle TrainingPelvic Floor Muscle Training plus Expiratory Muscle Strength Training

Expiratory muscle strength training will be done at home 7 days a week, once a day with 25 breaths, and a 1-minute rest cycle after every 5 breaths.

Pelvic Floor Muscle Training plus Expiratory Muscle Strength Training

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female participants with stress urinary incontinence are eligible for this study.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18-65 with SUI

You may not qualify if:

  • Presence of neurological disease
  • Neurogenic bladder findings,
  • Pregnancy,
  • Presence of malignancy,
  • History of abdominopelvic surgery or radiotherapy within the last 6 months,
  • Diagnosis of urinary tract infection,
  • Presence of uncontrolled hypertension,
  • Presence of advanced pelvic organ prolapse (stage 3 and above),
  • Pelvic floor muscle tightening strength \<2 according to the Modified Oxford Scale on digital examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence, Stress

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments will be performed by a physiotherapist who is blinded to group allocation and is not involved in delivering the interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 5, 2026

First Posted

July 9, 2026

Study Start

July 7, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

February 20, 2027

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share