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

2026年7月5日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

40

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
時間枠: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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Respiratory Muscle Strength Assessment
時間枠:Baseline and 8 weeks
Respiratory muscle strength will be measured using a portable measuring device.
Baseline and 8 weeks
Pelvic Floor Muscle Strength
時間枠:Baseline and 8 weeks
Pelvic floor muscle strength will be assessed using the Modified Oxford Scale.
Baseline and 8 weeks
Objective incontinence severity
時間枠: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
時間枠: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

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月7日

一次修了 (推定)

2026年9月15日

研究の完了 (推定)

2027年2月20日

試験登録日

最初に提出

2026年7月5日

QC基準を満たした最初の提出物

2026年7月5日

最初の投稿 (実際)

2026年7月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月9日

QC基準を満たした最後の更新が送信されました

2026年7月5日

最終確認日

2026年7月1日

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