Effect of Different Pelvic Floor Loading Techniques on Women With Stress Urinary Incontinence
調査の概要
状態
条件
詳細な説明
Stress incontinence results from an inability of the urethra to provide adequate resistance to the flow of urine with increased abdominal pressures. From a pathophysiologic perspective, stress incontinence may result from a lack of mechanical urethral support, resulting in urethral hypermobility and/or poor coaptation of the urethral tissues. Normally, forces that occur during the Valsalva maneuver are transmitted to the proximal urethra, resulting in compression of the urethra against the anterior vaginal wall; this process is disrupted in the setting of stress incontinence with urethral hypermobility.
The pelvic floor muscles (PFMs), including the levator ani muscle (LAMs), coccygeus, perineal muscles, striated urethral sphincter (SUS), and external anal sphincter, form the base of the abdomino-pelvic cavity and contribute to the support of the pelvic contents and continence control. The LAMs are considered a functional unit that provides support to the pelvic organs in the transverse plane (lifting) and compresses the urethra against the anterior vagina in the mid-sagittal plane (squeezing). Damage to or dysfunction of the LAMs is thought to be a contributor to stress urinary incontinence (SUI).
PFM-training, the most commonly used physical therapy treatment for women with SUI, is effective and therefore recommended as a first-line therapy.
According to traditional recommendations for PFM training programs, it is important to consider a gradual progression in the difficulty of the exercises, starting with less demanding positions (supine, standing, or side plank) and progressing to more complex challenges (quadruped hold, plank, and squat).
Vaginal Weights may be an effective training aid for women with mild to moderate stress incontinence, particularly in the absence of severe pelvic organ prolapse. They also may be useful for pelvic floor strengthening during the immediate postpartum period, as a behavioral program for continence maintenance, and for self-management programs.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Heba Al-Bahrawy, Master
- 電話番号：01003717687
- メール：hebabahrwy@gmail.com
研究連絡先のバックアップ
- 名前：Doaa Osman, As professor
- 電話番号：01115792245
- メール：Doaa.osman@cu.edu.eg
研究場所
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Cairo、エジプト
- Heba Allah Abdel salam Al-Bahrawy
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- All women are suffering from Stress urinary incontinence.
- Their age will range from 30-40 years.
- Their body mass index will range from 25-30 kg/m2.
- They are multiparous women (2-3 times).
Exclusion Criteria:
- Patient with denervated pelvic floor muscle, urinary tract infection, severe prolapse of pelvic organs, fibroid uterus, or intrauterine devices.
- Renal disease, pulmonary illness, chronic cough, and constipation.
- Underwent surgery for stress urinary incontinence.
- Other types of urinary incontinence (e.g., urge incontinence and mixed incontinence).
- Diabetic patients.
- Patient with anatomic changes (ectopic ureter, genito-urinary fistula)
- Patient with knee or back symptoms (Osteoarthritis or lumbar disc).
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：独身
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：Pelvic floor exercises with graduated loading positions group
The participants will perform pelvic floor exercises with graduated loading positions, 3 sessions per week, for 12 weeks.
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The participants will be instructed to perform and repeat each exercise 10 times to build core muscle strength. They will then maintain the position comfortably for 1-5 minutes without engaging the pelvic floor muscles. Afterward, they will begin pelvic floor muscle exercises from each position, including quick flicks, slow contractions, and sustained contractions. The maintenance time will be gradually increased. Each position will be performed under both stable and unstable conditions: (i) Stable side-lying position, with lateral support of the body on the floor (ii) Unstable side-lying position, side plank. (iii) Stable quadruped, with support of the knees on the floor. (iv) Unstable quadruped, off-knees quadruped hold. (v) Stable standing, with support of the back against the wall. (vi) Unstable standing, without support. (vii) Stable squat, or wall squat with back supported against the wall. (viii) Unstable squat, parallel squat |
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実験的：Pelvic floor exercises with graduated vaginal weights group
The participants will perform pelvic floor exercises with graduated vaginal weights, 3 sessions per week, for 12 weeks.
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The participants will perform pelvic floor exercises using graduated vaginal weights (cones). The vaginal cone is inserted into the vagina, and pelvic muscle contractions are used to hold it in place during a standing position. The procedure will begin with the lightest cone (white), in a position preferred by each patient. After inserting the vaginal cone, the pelvic muscles will contract for around 2 seconds to hold the cone in place. Initially, contractions of a few seconds will be repeated 10 times, with rest periods of 5-10 seconds between each contraction. As the patient progresses, the contraction duration will gradually increase. To determine when to move to the next cone with a heavier weight, the following exercises will be performed: walking for at least one minute, going up and down the stairs, jumping on the spot for at least thirty seconds, coughing 10 to 15 times, and washing hands under cold water for one minute. |
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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Assessment of pelvic floor muscle strength
時間枠：3 months
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The Kegel perineometer will be used to assess pelvic floor muscle strength.
It provides an indirect measure of strength generated via a change in pressure within a balloon connected to a pressure sensor.
A vaginal probe designed to detect pressure changes is inserted within the vaginal canal, as first developed by Kegel.
This pressure change reflects muscular force, as the largest change from resting pressure to peak pressure recorded during the contraction.
it can also measure the endurance by recording repeated and sustained contractions, which reflect the overall muscular capability of both slow and fast-twitch fiber activity.
The Perineometer is considered a highly reproducible and reliable tool, showing the pressure (in millimeters of mercury) as a measure of PFM strength.
Vaginal squeeze pressure that is normally around 40 to 60 mmHg.
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3 months
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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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Measurement of urethral angle (α)
時間枠：3 months
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Ultrasonography is a reliable, non-invasive, and comfortable method that provides dynamic evaluation in the examination of urethral mobility.
Transperineal ultrasonography has also been introduced to evaluate the mobility of the bladder neck and proximal urethra by measuring the urethral angle, the angle between the proximal urethra axis and the long axis of the symphysis pubis (α angle) during rest comfortably filled bladder.
Patients will be asked to fully strain by verbally directing to push and cough, and the maximum Valsalva image will be obtained with the help of cine-loop function, and the new angle will be measured.
The differences of angles at rest and strain (rotation angles) will be recorded as the urethral angle (α).
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3 months
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Assessment of stress urinary incontinence Severity
時間枠：3 months
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Urinary Incontinence Severity Index will be used to assess stress urinary incontinence severity.
It is a valid questionnaire consisting of two questions that determine an overall score by multiplying the frequency of urinary incontinence and the quantity of urine leakage.
The severity will be categorized as mild (1-2), moderate (3-6), severe (8-9), and extremely severe (12).
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3 months
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Assessment of stress urinary incontinence Impact on Quality of Life
時間枠：3 months
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International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) will be used to assess quality of life(QoL).
This is a simple and brief self-administered questionnaire consisting of six questions.
The first two questions address demographic variables, while the next four questions focus on the frequency, amount of leakage, and overall impact on QOL.
Additionally, a non-scored item assesses the type of incontinence.
Scoring will range from 0 to 21, with higher scores indicating increased severity
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3 months
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協力者と研究者
スポンサー
捜査官
- スタディチェア：khadyga Abdul Aziz, Professor、Cairo University
- スタディディレクター：Hossam Kamel, professor、Al-Azhar University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- P.T.REC/012/006107
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
米国FDA規制機器製品の研究
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