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

5 de julio de 2026 actualizado por: Yasemin KARAASLAN, Mustafa Kemal University

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Pelvic Floor Muscle Training
Women will receive a pelvic floor muscle training program.
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.
As part of the PTKE program, women will be taught rapid-maximal isolated contractions and multiple-repeated submaximal isolated contractions via vaginal palpation.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Periodo de tiempo: Baseline and after 8 weeks of intervention.
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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Respiratory Muscle Strength Assessment
Periodo de tiempo: Baseline and 8 weeks
Respiratory muscle strength will be measured using a portable measuring device.
Baseline and 8 weeks
Pelvic Floor Muscle Strength
Periodo de tiempo: Baseline and 8 weeks
Pelvic floor muscle strength will be assessed using the Modified Oxford Scale.
Baseline and 8 weeks
Objective incontinence severity
Periodo de tiempo: Baseline and 8 weeks
Objective severity of incontinence will be assessed using a 1-hour pad test.
Baseline and 8 weeks
Patient Global Change (Improvement) Perception Scale
Periodo de tiempo: In week 8
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

7 de julio de 2026

Finalización primaria (Estimado)

15 de septiembre de 2026

Finalización del estudio (Estimado)

20 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

5 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de julio de 2026

Publicado por primera vez (Actual)

9 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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