Flyte Device for Improving Urinary Incontinence Among Endometrial and Cervical Cancer Survivors Who Have Undergone Radiation Therapy
2026年8月27日 更新者：Shariska Harrington、Mayo Clinic
Flyte System Transvaginal Mechanotherapy for Urinary Incontinence in Endometrial and Cervical Cancer Survivors: A Pilot Study
This clinical trial studies how well and how easy it is to use a device called Flyte in improving problems with bladder control (urinary incontinence) among endometrial and cervical cancer survivors who have undergone radiation therapy.
Urinary incontinence is common after pelvic radiation therapy and can affect daily life and well-being.
Access to in-person pelvic floor physical therapy can be limited.
The Flyte device is designed for in-home use to deliver a series of mechanical vibrations at a specific frequency while the pelvic floor muscles are contracting and relaxing (i.e., normal, guided Kegel exercises).
This treatment is called mechanotherapy.
The Flyte device may improve urinary incontinence symptoms, as well as overall quality of life among endometrial and cervical cancer survivors who have undergone radiation therapy.
調査の概要
状態
募集
研究の種類
介入
入学 (推定)
44
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：Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
研究連絡先のバックアップ
- 名前：Kelly Gunderson
- 電話番号：507-422-1892
研究場所
-
-
Minnesota
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Rochester、Minnesota、アメリカ、55905
- 募集
- Mayo Clinic in Rochester
-
コンタクト：
- Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
-
コンタクト：
- Kelly Gunderson
- 電話番号：507-422-1892
-
主任研究者：
- Shariska Harrington, MD
-
-
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:
- Female patients who have received conventionally fractioned adjuvant or primary pelvic radiation therapy for endometrial or cervical cancer ≥ 3 months prior to registration
- Age ≥ 21 years at enrollment
- English speaking
- Demonstrates understanding of the study protocol and has signed the Informed Consent Form (ICF)
- Has a clinical diagnosis of urinary incontinence (stress urinary incontinence [SUI], urge urinary incontinence [UUI], mixed) or overactive bladder (OAB)
- Ability to contract the pelvic floor muscles (PFMs) without pain
- Ability to tolerate size 6 vaginal dilator
- Internet access
- Access to an iOS or Android smartphone or tablet with capabilities to download and use the Flyte app
- Willing and able to participate in follow-up
Exclusion Criteria:
- Participation in another clinical study which may interfere with study requirements
- Currently receiving active cancer directed therapy (i.e., cytotoxic chemotherapy) in post hysterectomy patients
- Completion of radiation therapy or surgery within 3 months of enrollment
- Life expectancy is less than six months in the opinion of the investigator
- Inability to tolerate insertion of the intravaginal wand. This will be recorded to support the usability of Flyte secondary endpoint
- Suspected vesicovaginal or colovaginal fistula
- Physical limitations that impede the patient's ability to participate (e.g., ability to grasp the wand and insert it and ability to turn on the Flyte controller unit)
- Acute infection or hematuria
- Inability to contract the PFMs or pain with contraction, as confirmed with intravaginal exam
- Impaired cognitive function or neurologic conditions
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：デバイスの実現可能性
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：Group 1 (Flyte device)
Patients use the Flyte device over 5 minutes daily during Kegel exercises for 12 weeks in the absence of unacceptable toxicity.
|
Patients are interviewed on study
Use Flyte device
Participants complete questionnaires on study
|
|
アクティブコンパレータ：Group 2 (referral, education)
Patients receive a referral for in-person pelvic floor physical therapy and educational handouts on Kegel exercises on study.
|
Patients are interviewed on study
Participants complete questionnaires on study
Given educational handouts
他の名前：
Given referral for in-person pelvic floor physical therapy
他の名前：
|
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 |
|---|---|---|
|
Incidence of all serious adverse events (SAEs) including unanticipated adverse device effects
時間枠：Up to 90 days the last administration of study treatment
|
Will be summarized descriptively and reported as the number and proportion of participants experiencing at least one event.
Events will be listed and summarized by severity, seriousness, and relationship to device use as assessed by the investigator.
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Up to 90 days the last administration of study treatment
|
|
Incidence of all device failures and malfunctions
時間枠：Up to 24 weeks
|
Will be summarized descriptively and reported as the number and proportion of participants experiencing at least one event.
Events will be listed and summarized by severity, seriousness, and relationship to device use as assessed by the investigator.
|
Up to 24 weeks
|
|
Proportion of participants successfully completing study set up (Feasibility)
時間枠：Up to 24 weeks
|
Feasibility will be considered acceptable if at least 65% of participants successfully complete study setup (receipt of the device, completion of onboarding, and download and activation of the mobile application).
|
Up to 24 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of Life (QoL) - ICIQ-UI-SF
時間枠：Baseline up to 24 weeks
|
Assessed using the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI-SF), a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL).
The ICIQ-UI-SF consists of 4 questions related to urine leakage over the past 4 weeks.
A score of 0 indicates no leakage and no impact on daily quality of life.
Higher scores denote greater symptom severity and a more profound impact on daily functioning.
Participants will be categorized into two strata based on their baseline ICIQ-UI-SF score: ≤12 (mild to moderate severity) and ≥13 (severe severity).
|
Baseline up to 24 weeks
|
|
Quality of Life (QoL) - EPIC
時間枠：Baseline up to 24 weeks
|
Assessed using the Expanded Prostate Cancer Index Composite (EPIC) urinary and bowel domains, a questionnaire designed to measure QoL in patients with cancer.
The questionnaire consists of 26 questions answered on various scales (e.g., a scale of 0-4 where 0=no problem and 4=big problem).
Higher scores indicate better quality of life.
|
Baseline up to 24 weeks
|
|
Change in patient satisfaction with personal goal achievement
時間枠：Baseline up to 24 weeks
|
Will be assessed using progress toward personal goals data collected within the Flyte app.
Goal attainment measures will be summarized descriptively, including the proportion of participants reporting improvement or achievement of personal goals over time.
|
Baseline up to 24 weeks
|
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Change in pelvic floor muscle function
時間枠：Baseline up to 24 weeks
|
Will be assessed using device-generated metrics, including change in maximum average contraction and change in the range between maximum average contraction and maximum average relaxation.
These measures will be summarized descriptively.
|
Baseline up to 24 weeks
|
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Adherence and usability of the Flyte system - frequency of use
時間枠：Up to 24 weeks
|
Will be assessed using app-derived usage data (e.g., how many times they accessed the app) and summarized descriptively.
|
Up to 24 weeks
|
|
Adherence and usability of the Flyte system - session completion
時間枠：Up to 24 weeks
|
Will be assessed using app-derived usage data (e.g., session completion) and summarized descriptively.
|
Up to 24 weeks
|
|
Change in perceived sexual function - FSFI
時間枠：Up to 24 weeks
|
Assessed using the Female Sexual Function Index (FSFI), a questionnaire used to assess female sexual feelings and responses during the past 4 weeks.
The FSFI consists of 19 questions answered using various scales such as 0-5 where 0=no sexual activity, 1=very low or none at all, 2=low, 3-moderate, 4=high, and 5=very high.
Scores range from 2-36 with higher scores indicating greater levels of sexual functioning.
|
Up to 24 weeks
|
|
Efficacy of Flyte therapy on other pelvic floor disorders
時間枠：Up to 24 weeks
|
Assessed using the gynecologic subset of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE-GYN). The PRO-CTCAE was developed to assess patient self-reported symptoms in cancer clinical trials. The questionnaire consists of 27 questions related to symptoms and side effects experienced over the past 7 days. Each question is answered on a 5-point scale (e.g., none, mild, moderate, severe, very severe or never, rarely occasionally, frequently, almost constantly). The final question is a yes/no question about any other symptoms with opportunity to list any not included in the assessment. Higher scores indicate that patients are experiencing worse or more frequent/severe symptoms and side effects. |
Up to 24 weeks
|
|
Meaningful change in urinary incontinence
時間枠：Up to 24 weeks
|
Assessed using the narrative description and personalized meaningful change description sections of the Anchored Episodic Recall (AER) exercise, a psychological and cognitive intervention technique adapted for use to retrain bladder signaling.
Results will be analyzed descriptively.
|
Up to 24 weeks
|
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。
スポンサー
捜査官
- 主任研究者：Shariska Harrington, MD、Mayo Clinic in Rochester
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
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 (実際)
2026年8月20日
一次修了 (推定)
2028年8月20日
研究の完了 (推定)
2028年8月20日
試験登録日
最初に提出
2026年6月16日
QC基準を満たした最初の提出物
2026年6月22日
最初の投稿 (実際)
2026年6月23日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月31日
QC基準を満たした最後の更新が送信されました
2026年8月27日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
- 泌尿生殖器疾患
- 生殖器疾患
- 泌尿生殖器腫瘍
- 部位別新生物
- 新生物
- 男性の泌尿生殖器疾患
- 泌尿器疾患
- 女性の泌尿生殖器疾患
- 女性の泌尿生殖器疾患と妊娠合併症
- 下部尿路の症状
- 泌尿器症状
- 子宮の病気
- 生殖器疾患、女性
- 性器腫瘍、女性
- 子宮頸部疾患
- 子宮腫瘍
- 膀胱疾患
- 病理学的状態、徴候および症状
- 徴候と症状
- 子宮頸部腫瘍
- 子宮内膜腫瘍
- 膀胱、過活動
- 専門的な実践
- 組織と管理
- 保健サービス管理
- ヘルスケアの質、アクセス、評価
- 調査手法
- 疫学的方法
- 診断技術と手順
- 診断
- データ収集
- ヘルスケア評価メカニズム
- ヘルスケアの質
- 公衆衛生
- 環境と公衆衛生
- 医療サービス
- 医療施設の労働力とサービス
- 児童保健サービス
- コミュニティヘルスサービス
- 予防保健サービス
- 社会経済的要因
- 人口特性
- 方法
- トピックとしてのインタビュー
- 早期介入、教育
- 教育ステータス
- 紹介と相談
- 身体検査
その他の研究ID番号
- 25-011307
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
はい
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。