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A Comparison of Home-Based Kegel Exercises Versus Clinic-Based Rehabilitation in Women With Urinary Incontinence in the Tabuk Region: A Randomized Controlled Trial (Incontinence)

2026年8月26日 更新者:Enas Elsayed Mohamed Abutaleb、University of Tabuk

Background Urinary incontinence (UI) is a common condition among women that significantly affects physical health, emotional well-being, social participation, and overall quality of life. Pelvic floor muscle training (PFMT) is widely recommended as the first-line conservative treatment for urinary incontinence. While clinic-based rehabilitation provides direct supervision by healthcare professionals, home-based Kegel exercise programs offer greater convenience and accessibility. However, limited evidence exists regarding the comparative effectiveness of these approaches among women in Saudi Arabia.

Aim The study aims to compare the effectiveness of home-based Kegel exercises and clinic-based rehabilitation programs in improving pelvic floor muscle strength, reducing urinary incontinence symptoms, and enhancing quality of life among women with urinary incontinence in the Tabuk region.

Objectives

  1. To evaluate the effectiveness of home-based Kegel exercises in women with urinary incontinence.
  2. To evaluate the effectiveness of clinic-based pelvic floor rehabilitation.
  3. To compare outcomes between both intervention approaches.
  4. To compare the outcomes of both interventions regarding pelvic floor muscle strength, urinary leakage, and quality of life.
  5. To assess participants' adherence to the prescribed exercise programs. Methodology

This study will employ a randomized controlled trial (RCT) design. Eligible women diagnosed with urinary incontinence will be recruited from the Maternity and Children Hospital, Tabuk. Participants will be randomly assigned to one of two groups:

  • Group A: Home-based Kegel exercise program.
  • Group B: Supervised clinic-based pelvic floor rehabilitation program. Both interventions will be conducted over a 12-week period. Outcome Measures

The effectiveness of the interventions will be evaluated using:

  • Perineometer measurements to assess pelvic floor muscle strength.
  • Pad Test to assess urinary leakage severity.
  • King's Health Questionnaire (KHQ) to evaluate quality of life.
  • Adherence records to monitor compliance with the exercise program. Assessments will be conducted at baseline, week 8, and week 12. Data Analysis Data will be analyzed using SPSS software. Descriptive statistics, independent t-tests, Chi-square tests, and repeated-measures ANOVA will be used to compare outcomes between groups. Statistical significance will be set at p < 0.05.

Ethical Considerations Ethical approval will be obtained prior to study commencement. Written informed consent will be obtained from all participants. Participation will be voluntary, confidentiality will be maintained, and participants will have the right to withdraw from the study at any time without affecting their healthcare services.

Expected Outcomes The study is expected to demonstrate improvements in pelvic floor muscle strength, urinary continence, and quality of life in both groups. The findings will provide evidence regarding whether home-based Kegel exercises can achieve outcomes comparable to supervised clinic-based rehabilitation, thereby informing future physiotherapy practice and healthcare policy.

Significance This research will contribute to the growing body of evidence on pelvic floor rehabilitation and may support the implementation of accessible, cost-effective, and evidence-based treatment options for women with urinary incontinence in Tabuk region in Saudi Arabia. The results may also guide clinicians and healthcare decision-makers in optimizing rehabilitation services and improving patient outcomes.

調査の概要

研究の種類

介入

入学 (推定)

100

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

    • Tabuk Region
      • Tabuk、Tabuk Region、サウジアラビア
        • Maternity and Children Hospital in Tabuk
        • コンタクト:

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

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Female participants aged 20-50 years.
  • Diagnosed with urinary incontinence.
  • Able to understand study instructions.
  • Willing to provide informed consent

Exclusion Criteria:

  • Delivery within the previous 3 months.
  • Gynecological surgery during the previous 3 months.
  • Lower urinary tract surgery during the previous 3 months.
  • Postmenopausal women.
  • Contraindications to pelvic floor muscle training.

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:ランダム化
  • 介入モデル:並列代入
  • マスキング:トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的:Home-Based Kegel Exercises
Women diagnosed with urinary incontinence in this arm attending the Women's Department of Maternity and Children Hospital will use an AI trainer called Kegel trainer for 12 weeks focusing on strengthening the pelvic floor muscles. They will join a telegram group supervised by the caregiver to follow their interactions during the whole period.
Kegel exercises are designed to focus on strengthening the weak pelvic floor muscles by using Kegel Trainer Application over 9 levels.
他の名前:
  • Kegel Trainer
  • Pelvic floor muscle exercises
実験的:Clinic-Based Rehabilitation Program
Women diagnosed with urinary incontinence in this arm attending the Women's Department of Maternity and Children Hospital will be supervised by the Physiotherapist at the department for two times per week during the Kegel training for pelvic floor muscles training for 12 weeks .
Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months

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
Perineometer
時間枠:From enrollment to the end of treatment at 12 weeks
Pelvic floor muscle strength will be measured using a perineometer
From enrollment to the end of treatment at 12 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
long-term Pad Test
時間枠:From enrollment to the end of treatment at 12 weeks
Urinary leakage severity will be measured using the long-term Pad Test
From enrollment to the end of treatment at 12 weeks
King's Health Questionnaire
時間枠:From enrollment to the end of treatment at 12 weeks
• Quality of life will be measured using the King's Health Questionnaire
From enrollment to the end of treatment at 12 weeks

協力者と研究者

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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8月1日

一次修了 (推定)

2027年1月31日

研究の完了 (推定)

2027年2月28日

試験登録日

最初に提出

2026年8月26日

QC基準を満たした最初の提出物

2026年8月26日

最初の投稿 (実際)

2026年8月31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26日

最終確認日

2026年6月1日

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