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Not yet recruitingNCT07693920Updated Jul 9, 2026

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

An interventional study of Pelvic Floor Muscle Training and Expiratory muscle strength training in Stress Urinary Incontinence (SUI), sponsored by Mustafa Kemal University. Not yet recruiting. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Mustafa Kemal University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Stress Urinary Incontinence (SUI)

Keywords

  • stress urinary incontinence
  • women
  • pelvic floor muscle training
  • Expiratory muscle strength training
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women aged 18-65 with SUI

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Pelvic Floor Muscle Training

    Women will receive a pelvic floor muscle training program.

    Behavioral: Pelvic Floor Muscle Training

  • 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 · Behavioral: Expiratory muscle strength training

Interventions

  • BehavioralPelvic 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.

  • BehavioralExpiratory 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.

05

What researchers measure

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).

    Time frame: Baseline and after 8 weeks of intervention.

Secondary outcomes

  1. Respiratory Muscle Strength Assessment

    Respiratory muscle strength will be measured using a portable measuring device.

    Time frame: Baseline and 8 weeks

  2. Pelvic Floor Muscle Strength

    Pelvic floor muscle strength will be assessed using the Modified Oxford Scale.

    Time frame: Baseline and 8 weeks

  3. Objective incontinence severity

    Objective severity of incontinence will be assessed using a 1-hour pad test.

    Time frame: Baseline and 8 weeks

  4. 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".

    Time frame: In week 8

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07693920
Lead sponsor
Mustafa Kemal University
Responsible party
Yasemin KARAASLAN (Associate Professor, Mustafa Kemal University) — Principal investigator
First posted
Jul 9, 2026
Start date
Jul 7, 2026 (estimated)
Primary completion
Sep 15, 2026 (estimated)
Completion
Feb 20, 2027 (estimated)
Last update
Jul 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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