이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 7월 5일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

40

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Respiratory Muscle Strength Assessment
기간: Baseline and 8 weeks
Respiratory muscle strength will be measured using a portable measuring device.
Baseline and 8 weeks
Pelvic Floor Muscle Strength
기간: Baseline and 8 weeks
Pelvic floor muscle strength will be assessed using the Modified Oxford Scale.
Baseline and 8 weeks
Objective incontinence severity
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 7일

기본 완료 (추정된)

2026년 9월 15일

연구 완료 (추정된)

2027년 2월 20일

연구 등록 날짜

최초 제출

2026년 7월 5일

QC 기준을 충족하는 최초 제출

2026년 7월 5일

처음 게시됨 (실제)

2026년 7월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 5일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다