The Nolix Feasibility Efficacy and Safety Study
2021年8月9日 更新者：Gynamics LTD
A Feasibility Efficacy and Safety Study of the Nolix Vaginal Device for the Temporary Management of Stress Urinary Incontinence in Women
This study is an open label, prospective, feasibility study with the Nolix device used for temporary treatment of Stress Urinary Incontinence (SUI) in subjects, serving as their own controls.
調査の概要
詳細な説明
This is an open label, prospective, feasibility study with the Nolix device used in subjects with SUI, serving as their own controls.
The objective of this study is to evaluate the effectiveness (both objective and subjective) and safety of the Nolix device when used for the temporary management of SUI in women.
In addition, the study is aimed to evaluate changes in the quality of life (QoL) and comfort during use of the Nolix device.
The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least >-50% of the mean %PWG change during the last 7 days of the treatment phase as compared to the control phase.
Additional effectiveness endpoints include the number of self-reported SUI episodes per week, the percentage of subjects who experience a greater than -50% change in the number of self-reported daily incontinence episodes, as well as the changes in the QoL, leak scores and overall satisfaction levels.
The safety of the Nolix device is also evaluated by assessing the adverse events, including the results of urinalysis, vaginal swab, and vaginal examination.
研究の種類
介入
入学 (実際)
32
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。
研究場所
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Haifa、イスラエル
- Carmel Medical Center
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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
21年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- Females aged 22 and above.
- Suffering from Stress Urinary Incontinence.
- Women who can understand the nature of the study, are physically able to perform all required tasks and consent to it by signing a written Informed Consent Form prior to participation in the study.
Exclusion Criteria:
- Age ≤ 21 years.
- Pregnant or planning to become pregnant during the study.
- Vaginal birth or Cesarean section for the last 3 months prior to entering the study.
- Severely atrophic vagina.
- A history of Toxic Shock Syndrome (TSS).
- Active urinary tract or vaginal infection.
- Patients prone to recurrent vaginal or urinary tract infections (i.e. more than 3 times in the past year).
- Has experienced unusual or unexpected vaginal bleeding within the last 6 months.
- Vaginal surgery within the last 3 months prior to entering the study.
- Has experienced difficulties with the use of intra-vaginal devices, including tampons.
- Presence of any condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Average daily PWG as measured in the baseline pad period is less than 4 grams /12 hours.
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：なし
- 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 |
|---|---|
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実験的：Nolix デバイス
デバイスの使用と非治療（パッドのみ）段階の比較
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For temporary management of SUI
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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 |
|---|---|---|
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Mean pad weight gain (PWG) change of >50% when comparing the PWG control phase as compared to the Nolix device phase.
時間枠：21 days
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The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least >50% of the mean %PWG reduction during the last 7 days of the treatment phase as compared to the control phase.
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21 days
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Device-related adverse events
時間枠：21 days
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Discomfort / pain, vaginal irritation or itching, vaginal spotting, vaginal or urinary tract infections
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21 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in number of self-reported incontinence episodes.
時間枠：21 days
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Change in number of self-reported incontinence episodes per week from the control period to the Nolix device use period.
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21 days
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More than 50% reduction in the number of self-reported daily incontinence episodes.
時間枠：21 days
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Percentage of subjects who experience a greater than 50% reduction in the number of self-reported daily incontinence episodes from the baseline period to the Nolix device use period.
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21 days
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Changes in Quality of Life (QoL).
時間枠：21 days
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The QoL Questionnaire (measured on a 0-100 scale) will be performed at baseline and after the device-use period and refer to areas which may have been influenced or changed by accidental urine loss and/or prolapse.
A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life.
In the same manner, a reduction in scores from baseline reflects improved quality of life.
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21 days
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Changes in Leak Score.
時間枠：21 days
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Changes in Leak Score from the baseline period to the Nolix device use period, as measured using the Leak Score Questionnaire.
The Leak Score Questionnaire will be performed (on a 0-3 scale) to evaluate the subjective perception of incontinence during eight effort demanding activities: coughing, laughing, sneezing, jumping, lifting heavy objects, walking, running, and going to the gym.
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21 days
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PWG measured continuously.
時間枠：21 days
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PWG measured continuously (as opposed to responder analysis), using the same definition of PWG as described above, without transformation to percent.
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21 days
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Comfort during Nolix device use.
時間枠：21 days
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Comfort during Nolix device use will be measured through the Satisfaction Questionnaire, using a 10-point scale (where 1 is the most negative response and 10 the most positive, during the use of the device).
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21 days
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Overall perception of improvement.
時間枠：21 days
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Overall perception of improvement following the use of the Nolix device, as measured using the Patient Global Impression of Improvement (PGI-I) Scale, measured on a 7-point scale (where 1 is the most positive response and 7 the most negative response).
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21 days
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Overall satisfaction: Patient Satisfaction Question (PSQ)
時間枠：21 days
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Overall satisfaction with the use of the Nolix device, as measured using the Patient Satisfaction Question (PSQ),selecting one of the following answers: 'Completely'; 'Somewhat'; or 'Not at all'.
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21 days
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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：Boris Fridman, Dr.、Carmel Medical Center
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)
2019年1月1日
一次修了 (実際)
2020年3月31日
研究の完了 (実際)
2020年3月31日
試験登録日
最初に提出
2019年10月22日
QC基準を満たした最初の提出物
2019年10月27日
最初の投稿 (実際)
2019年10月29日
学習記録の更新
投稿された最後の更新 (実際)
2021年8月16日
QC基準を満たした最後の更新が送信されました
2021年8月9日
最終確認日
2021年8月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
All personal data gathered in this trial will be treated in strictest confidence by investigators, monitors, sponsor's personnel and independent ethics committee.
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
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。
Nolix Deviceの臨床試験
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Ohio State UniversityMedical University of South Carolina; Northwestern University終了しました
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Cardiva Medical, Inc.完了