Effects of Pelvic Floor Muscle Training Combined With Bladder Training on Some Parametrs of Men With Urinary Frequency
Effects of Pelvic Floor Muscle Training Combined With Bladder Training on Urinary Frequency, Pelvic Floor Function, and Post-Void Residual Volume in Men With Urinary Frequency: A Randomized Controlled Trial
調査の概要
状態
条件
詳細な説明
Study Design:
Prospective Single-center Parallel-group 1:1 randomized Assessor-blinded RCT CONSORT-compliant
Inclusion Criteria:
Male Age 18-65 years Complaint of urinary frequency persisting for at least 3 months
On a 3-day bladder diary:
≥8 voids/24 hours Provision of written informed consent Sufficient cognitive capacity to learn pelvic floor muscle contraction
Exclusion Criteria:
Active urinary tract infection Prostate cancer Prostate surgery within the last 12 months
Neurological diseases:
Parkinson's disease Multiple sclerosis (MS) Stroke Spinal cord injury Neurogenic bladder due to diabetes mellitus Bladder stones Bladder tumor Urethral stricture
Within the last 3 months:
PFMT (pelvic floor muscle training) Biofeedback PTNS (percutaneous tibial nerve stimulation) Tibial nerve stimulation Recent dose change in antimuscarinic or β3-agonist therapy Randomization Computer-generated block randomization Block size of 4 or 6 Allocation concealment Sealed opaque envelopes
Assessment Time Points T0 = Baseline T1 = Week 6 T2 = Week 12 T3 = 6-month follow-up Primary Outcome 3-day bladder diary 24-hour voiding frequency
Secondary Outcomes OAB-V8 Symptom severity ICIQ-OAB Quality of life and symptom impact PGI-I Patient global impression of improvement
Ultrasound Measurements A) Pelvic Floor Muscle Strength Transabdominal ultrasound
During maximum voluntary contraction:
Bladder neck elevation (mm) 3 repetitions Average will be calculated
B) Pelvic Floor Muscle Endurance Following maximum contraction 10-second hold Duration of bladder neck elevation maintenance or Percentage of elevation maintained over 10 seconds
C) Post-Void Residual Volume (PVR) Via ultrasound Within the first 5 minutes after voiding Recorded in mL
Interventions Group 1 Bladder Training Urge suppression strategies Extending voiding intervals Fluid management Caffeine education ● (placeholder/bullet) Pelvic Floor Muscle Training 8 weeks
1 face-to-face session per week Home exercise program Fast contractions: 10 reps × 3 sets Maximal (sustained) contractions: 10 reps × 10 seconds each Functional contractions: To be performed when urgency is felt
Group 2 Bladder training only Same follow-up frequency Same training duration
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：Hasan Bingöl, Assoc. Prof, PhD
- 電話番号：5595 +90 0(426) 216 0012
- メール：hesenbingol@gmail.com
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:
- Male sex
- Age 18-65 years
- Complaint of urinary frequency persisting for at least 3 months
- On a 3-day bladder diary: ≥8 voids per 24 hours
- Provision of written informed consent Sufficient cognitive capacity to learn pelvic floor muscle contraction (assessed by clinical judgment)
Exclusion Criteria:
- Active urinary tract infection
- Prostate cancer
- Prostate surgery within the last 12 months
- Parkinson's disease, Multiple sclerosis (MS), Stroke, Spinal cord injury
- Neurogenic bladder due to diabetes mellitus
- Bladder stones, Bladder tumor, Urethral stricture
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 |
|---|---|
|
アクティブコンパレータ：Group 1: Intervention group
Bladder Training + Pelvic Floor Muscle Training
|
Bladder training includes strategies for suppressing urgency, gradually extending the intervals between voiding, managing fluid intake, and reducing caffeine consumption.
The pelvic floor muscle training component involves three types of contractions: fast contractions (10 repetitions, 3 sets), maximal sustained contractions (10 repetitions, held for 10 seconds each), and functional contractions integrated into daily activities to improve real-life muscle control.
|
|
アクティブコンパレータ：Group 2: Control group
Group 2: Bladder Training Alone
|
Bladder training includes strategies for suppressing urgency, gradually extending the intervals between voiding, managing fluid intake, and reducing caffeine consumption
|
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 |
時間枠 |
|---|---|
|
Pelvic floor muscle strength as assessed by ultrasound
時間枠：From enrollment to the end of treatment at 12 weeks
|
From enrollment to the end of treatment at 12 weeks
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Carralero-Martinez A, Munoz Perez MA, Kauffmann S, Blanco-Ratto L, Ramirez-Garcia I. Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: A randomized controlled trial. Neurourol Urodyn. 2022 Apr;41(4):962-972. doi: 10.1002/nau.24903. Epub 2022 Mar 9.
- Siegel AL. Pelvic floor muscle training in males: practical applications. Urology. 2014 Jul;84(1):1-7. doi: 10.1016/j.urology.2014.03.016. Epub 2014 May 10.
- Clemens JQ, Nadler RB, Schaeffer AJ, Belani J, Albaugh J, Bushman W. Biofeedback, pelvic floor re-education, and bladder training for male chronic pelvic pain syndrome. Urology. 2000 Dec 20;56(6):951-5. doi: 10.1016/s0090-4295(00)00796-2.
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
その他の研究ID番号
- 2026/06-24.06.2026
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