Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women
Study of the Efficacy of Treatment of Fecal Incontinence in Community-dwelling Women: Assessment of Individual Efficacy on Anorectal Physiology and Cortical Plasticity, Its Impact on Clinical Severity and on Quality of Life.
調査の概要
詳細な説明
Fecal incontinence is a prevalent condition with a major impact on quality of life. Currently four treatments are being used in clinical practice: Kegel exercises (K), biofeedback (BF), electrostimulation (ES) and transcutaneous neuromodulation (NM). Results in the literature are discordant and lack methodological rigour making scientific evidence weak.
The aim of this study is to assess the efficacy of these four treatments on community-dwelling women and their impact on anorectal physiology, on clinical severity and on QoL.
This is a randomized control trial. Patient physiology was studied with anorectal manometry and endoanal ultrasonography; clinical severity was assessed with Cleveland and St. Mark's scales, and QoL with the Faecal Incontinence Quality of Life (FIQL) and the EuroQol's EQ5D questionnaires. Urinary incontinence (UI) was also evaluated by means of International Consultation on Incontinence (ICIQ) score. Patients were randomized and assigned to K (control), BF+K, ES+K or NM+K, given active treatment for a 3-month period, and then evaluated again with identical tests and parameters to identify changes.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age higher than 18
- To be woman
- Have had incontinence episiodes at least from 6 month since the beginning of the study
- Have had incontinence episodes during the last month prior the beginning of the study
- The patient is able to understand the nature and impliations of the study and, therefore, to decide her participation.
Exclusion Criteria:
- Not meeting inclusion criteria
- Have very mild condition (Wexner <4)
- To be unable to perform / understand the treatments properly
- Being pregnant
- To have used treatmets for fecal incontinence within the last six months prior to the start of the study
- If, at reserarcher's criteria, the patient has not the proper conditions to perform and finish the treatments.
研究計画
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：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：Kegel exercises
Pelvic floor exercises designed in the 1950s' by Arnold Kegel.
|
The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects.
The basal treatment which other therapies are compared to is Kegel.
|
|
実験的：biofeedback
Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.
|
The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects.
The basal treatment which other therapies are compared to is Kegel.
|
|
実験的：electrostimulation
Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility.
|
The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects.
The basal treatment which other therapies are compared to is Kegel.
|
|
実験的：transcutaneous neuromodulation
Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes
|
The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects.
The basal treatment which other therapies are compared to is Kegel.
|
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 |
|---|---|---|
|
clinical severity
時間枠：Changes of severity after 3 month-treatment
|
severity of the symptoms measured with Cleveland score
|
Changes of severity after 3 month-treatment
|
|
maximum anal resting pressure
時間枠：Changes maximum anal resting pressure after 3 month-treatment
|
pressure of the anal canal measured with mmHg
|
Changes maximum anal resting pressure after 3 month-treatment
|
|
maximum squeeze pressure
時間枠：Changes maximum squeeze pressure after 3 month-treatment
|
pressure on the anal canal when squeezing measured with mmHg
|
Changes maximum squeeze pressure after 3 month-treatment
|
|
rectal sensitivity
時間枠：changes in rectal balloon filling after 3 month-treatment
|
patient's rectal perception, measured with cm3 of distention of a rectal balloon
|
changes in rectal balloon filling after 3 month-treatment
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。