Effects of a Multimodal and Multidimensional Intervention on Urinary Incontinence in Young Nulliparous Female Athletes. (PELVICATHLE)
2026年9月7日 更新者：Centre Hospitalier Universitaire de Saint Etienne
Effects of a Multimodal and Multidimensional Intervention on Urinary Incontinence in Young Nulliparous Female Athletes. Single-Center Randomized Controlled Stepped-Wedge Trial
A prevalence of urinary incontinence ranging from 5.7% to 80% has been observed in young nulliparous athletes during their activity.
The usual recommendations for managing adult women do not seem to be transferable.
Young nulliparous athletes need specific educational and behavioral interventions and an alternative to pelvic floor muscle strengthening.
A multimodal and multidimensional intervention for athletes and coaches combining specific pelvic health education and strengthening of lumbopelvic-abdominal stability appears to be an innovative and optimal solution for reducing the symptoms of urinary incontinence in young nulliparous women who participate in athletics.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
198
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Pascal EDOUARD, PHD
- 電話番号：+33 (0)477127985
- メール：pascal.edouard@univ-st-etienne.fr
研究連絡先のバックアップ
- 名前：Céline PEURIERE, CDP
- 電話番号：+33 (0)477120285
- メール：Celine.Peuriere@chu-st-etienne.fr
研究場所
-
-
-
Saint-Etienne、フランス、42055
- CHU de Saint-Etienne
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主任研究者：
- Pascal EDOUARD, PHD
-
コンタクト：
- Pascal EDOUARD, PHD
- 電話番号：+33 (0)477127985
- メール：pascal.edouard@univ-st-etienne.fr
-
-
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
- 子
- 大人
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria :
- Female subject, nulliparous
- Member of an athletics club affiliated with the French Athletics Federation (FFA)
- At least 15 years old at the start of the study and belonging to the U16/U18/U20/U23 categories (born between January 1, 2005, and September 1, 2011)
- Having internet access
- Having access to a digital device (computer, tablet, mobile phone)
- Affiliated with or covered by a social security scheme
- Having freely given their express consent, as well as the express consent of both parents for minor participants
Exclusion Criteria :
- Any individual deprived of their liberty or subject to legal protection (guardianship, curatorship, or protective supervision).
- A pregnant woman, a woman who has been pregnant, or a woman planning a pregnancy within the last nine months.
- Any individual unable to understand the purpose and conditions of the study.
- Any individual unable to give their consent.
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：他の
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Control condition
Usual activities
|
Collection of data on routine activities
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実験的：Interventional condition
Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening program.
|
The intervention will consist of participants: i) reviewing educational content (8 educational videos online) ii) participating in two in-person sessions at the athletics club and performing lumbar-pelvic-abdominal stability exercises iii) learning and implementing recommendations for empowering themselves in pelvic health management. iv) complete reports in 6 questionnaires during follow-up. |
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 |
|---|---|---|
|
Urinary incontinence symptoms
時間枠：Week 1, 7, 13, 19, 25, 31
|
Severity of urinary incontinence symptoms as measured by the ICIQ-UI-SF score (International Consultation on Incontinence Questionnaire - Short Form for Urinary Incontinence).
Scores typically range from 0 to 21.
The higher the score, the more severe the urinary incontinence.
|
Week 1, 7, 13, 19, 25, 31
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The program's effects on the prevalence of urinary incontinence
時間枠：Week 1, 7, 13, 19, 25, 31
|
The program's effects on the prevalence of urinary incontinence will be measured using the ICIQ-UI-SF questionnaire, with a dichotomous interpretation of the score: 0 = continent, ≥1 = incontinent.
|
Week 1, 7, 13, 19, 25, 31
|
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Effects of the intervention on athletes' knowledge of the pelvic-perineal region
時間枠：Week 1, 31
|
A questionnaire we have developed will measure the effects of the intervention on athletes' knowledge of the pelvic and perineal region.
It will consist of 10 questions.
This outcome will be assessed by comparing the mean number of correct answers (on a scale of 0 to 10) within and between groups.
|
Week 1, 31
|
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The program's effects on associated pelvic and perineal symptoms
時間枠：Week 1, 31
|
The ODS-S questionnaires measure associated pelvic and perineal symptoms.
This criterion will be assessed by comparing the mean total scores (on a scale of 0 to 20) within and between groups.
|
Week 1, 31
|
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The program's effects on urinary dysfunction.
時間枠：Week 1, 31
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Section C of the LURN-SI29 questionnaire, which assesses urinary dysfunction.
This criterion will be evaluated by comparing the mean total scores (on a scale of 0 to 20) within and between groups.
|
Week 1, 31
|
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Number of educational contents viewed
時間枠：Week 13, 19, 25
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Measured by tracking content views at the end of the session.
|
Week 13, 19, 25
|
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Practicing lower back, pelvic, and abdominal stability exercises
時間枠：Week 1, 7, 13, 19, 25, 31
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Measured by collecting the frequency of implementation.
|
Week 1, 7, 13, 19, 25, 31
|
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The dose-response effect related to adherence
時間枠：Week 1, 7, 13, 19, 25, 31
|
Assessed by measuring the effects on the ICIQ-UI-SF score based on the frequency of exercise implementation.
Scores typically range from 0 to 21.
The higher the score, the more severe the urinary incontinence.
|
Week 1, 7, 13, 19, 25, 31
|
|
Program satisfaction
時間枠：Week 31
|
Assessed using a questionnaire.
This criterion will be expressed as the average of the total scores for the satisfaction and recommendation questions (on a scale of 0 to 10).
A score of "10" indicates high satisfaction and a strong recommendation.
|
Week 31
|
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Trends in Top Athletic Performance
時間枠：Week 1, 7, 13, 19, 25, 31
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Measured by the best performance (time/distance) in the most common track and field event. Time is measured in seconds and minutes. Distance is measured in meters. |
Week 1, 7, 13, 19, 25, 31
|
|
Number of educational contents viewed by coaches
時間枠：Week 13, 19, 25
|
Measured by tracking content views at the end of the session
|
Week 13, 19, 25
|
|
Coaches' level of knowledge regarding the pelvic-perineal region
時間枠：Week 1, 31
|
Assessed using a 10-question questionnaire.
This criterion will be expressed through an intra-group and inter-group comparison of the average number of correct answers (on a scale of 0 to 10).
|
Week 1, 31
|
|
Practicing lumbar-pelvic-abdominal stability exercises
時間枠：Week 1, 7, 13, 19, 25, 31
|
Measured by collecting the frequency as specified in a questionnaire
|
Week 1, 7, 13, 19, 25, 31
|
|
Coaches' satisfaction with the program
時間枠：Week 31
|
Assessed using a questionnaire.
This criterion will be expressed as the average of the total scores for the satisfaction and recommendation questions (on a scale of 0 to 10).
A score of "10" indicates high satisfaction and a strong recommendation.
|
Week 31
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Pascal EDOUARD, PHD、CHU de Saint-Etienne
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9月1日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年6月2日
QC基準を満たした最初の提出物
2026年6月8日
最初の投稿 (実際)
2026年6月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月10日
QC基準を満たした最後の更新が送信されました
2026年9月7日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 26CH163
- ANSM (その他の識別子：2024-A02435-42)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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