The Effects of Expiratory Muscle Strength Training in Women With Stress Urinary Incontinence

Investigation of the Effects of Expiratory Muscle Strength Training in Addition to Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress Urinary Incontinence (SUI)
• Intervention / Treatment: Behavioral: Pelvic Floor Muscle Training; Behavioral: Expiratory muscle strength training

Detailed Description

According to the International Continence Society definition, stress urinary incontinence (SUI) is the involuntary leakage of urine during physical exertion, including exertion or sports activities, or during sneezing or coughing. Pelvic floor muscle training, a conservative approach, is recommended as the first-line treatment for SUI. As a classic approach, there is A-level evidence that isolated pelvic floor muscle training in women improves SUI and SUI-related quality of life. While inspiratory muscle training has been reported in the literature as effective in SUI, research on expiratory muscle strength training is needed. Therefore, studying expiratory muscle strength in SUI is important. Inclusion criteria for the study were: having SUI, being female, and being aged 18-65 years. Exclusion criteria were: The following criteria were contraindicated: 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), and pelvic floor muscle squeezing strength <2 on the Modified Oxford Scale during digital examination. Women will be randomly assigned to one of two intervention groups: Group 1: Pelvic Floor Muscle Training (PFMT) and Group 2: PFMT plus Expiratory Muscle Strength Training. The groups will be blinded. The intervention program will last 8 weeks in both groups. Women will be evaluated at the beginning of the study (before interventions) and at the end of the 8th week of intervention. Both groups will be asked to perform the exercises included in the PFMT program as a home program after being taught in the clinic, and individuals will be called for follow-up check-ups every two weeks with an exercise schedule. At each follow-up session, one set of exercises will be performed with the physiotherapist to re-check the accuracy of the exercises, and the number of exercises will be increased before the women are invited to the next appointment.

Respiratory muscle strength will be measured using a portable, electronic mouth pressure monitor. Pelvic floor muscle strength will be graded using the Modified Oxford Scale (MOS). Objective incontinence severity will be assessed with a 1-hour pad test. The subjective severity of incontinence and its impact on daily life will be assessed with the International Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF). At the end of treatment, women's perceptions of improvement in their urinary incontinence levels will be assessed using the "Patient Global Improvement Perception Scale". A device will be used in training to increase expiratory muscle strength. Expiratory muscle strength training will be done at home 7 days a week, once a day, with a cycle of 25 breaths, and a 1-minute rest after every 5 breaths. Women will be taught rapid-maximal isolated contractions and high-repetition submaximal isolated contractions via vaginal palpation as part of the PTKE program.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women aged 18-65 with SUI

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pelvic Floor Muscle Training; Women will receive a pelvic floor muscle training program.	Behavioral: Pelvic Floor Muscle Training; As part of the PTKE program, women will be taught rapid-maximal isolated contractions and multiple-repeated submaximal isolated contractions via vaginal palpation.
Experimental: Pelvic Floor Muscle Training plus Expiratory Muscle Strength Training; Participants will receive pelvic floor muscle training combined with Expiratory Muscle Strength Training.	Behavioral: Pelvic Floor Muscle Training; As part of the PTKE program, women will be taught rapid-maximal isolated contractions and multiple-repeated submaximal isolated contractions via vaginal palpation.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Muscle Strength Assessment	Respiratory muscle strength will be measured using a portable measuring device.	Baseline and 8 weeks
Pelvic Floor Muscle Strength	Pelvic floor muscle strength will be assessed using the Modified Oxford Scale.	Baseline and 8 weeks
Objective incontinence severity	Objective severity of incontinence will be assessed using a 1-hour pad test.	Baseline and 8 weeks
Patient Global Change (Improvement) Perception Scale	At the end of treatment, women's perceptions of improvement in their urinary incontinence levels will be evaluated using the "Patient Global Improvement Perception Scale".	In week 8

Collaborators and Investigators

• Sponsor: Mustafa Kemal University

Study record dates

Study Major Dates

• Study Start (Estimated): July 7, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): February 20, 2027

Study Registration Dates

• First Submitted: July 5, 2026
• First Submitted That Met QC Criteria: July 5, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 5, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: stress urinary incontinence; women; pelvic floor muscle training; Expiratory muscle strength training
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: PT-2026-67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No