Bladder Training With or Without Biofeedback-Assisted Pelvic Floor Muscle Training for Women With Wet Overactive Bladder
Adjunctive EMG Biofeedback-Assisted Pelvic Floor Muscle Training in Women With Wet Overactive Bladder and Urodynamically Confirmed Detrusor Overactivity: A Randomized Controlled Trial
Overactive bladder causes a sudden and difficult-to-control need to urinate and may be accompanied by urine leakage. Bladder training is commonly used as a first-line treatment. Pelvic floor muscle training supported by electromyographic biofeedback may help women recognize and contract the correct muscles and improve control of urgency and leakage.
The purpose of this randomized controlled trial was to determine whether adding electromyographic biofeedback-assisted pelvic floor muscle training to bladder training provides additional benefit compared with bladder training alone in women with wet overactive bladder and urodynamically confirmed detrusor overactivity.
A total of 64 women were randomly assigned in a 1:1 ratio to receive either bladder training alone or bladder training plus electromyographic biofeedback-assisted pelvic floor muscle training. Both interventions lasted 8 weeks. Participants in the combined intervention group received 24 supervised biofeedback sessions in addition to bladder training.
The primary outcome was the change in daily voiding frequency measured using a 3-day bladder diary. Secondary outcomes included urgency, urgency urinary incontinence, nocturia, incontinence-related quality of life, pelvic floor muscle function, treatment adherence, treatment satisfaction, and adverse events. Outcomes were assessed at baseline and at week 8.
調査の概要
状態
詳細な説明
This was an assessor-blinded, two-arm, parallel-group randomized controlled trial conducted in women with wet overactive bladder and urodynamically confirmed detrusor overactivity.
Eligible participants were randomly assigned in a 1:1 ratio to a bladder training group or a bladder training plus electromyographic biofeedback-assisted pelvic floor muscle training group. All participants received an 8-week bladder training program that included education, counseling on fluid intake and bladder irritants, timed voiding, progressive extension of voiding intervals, and urgency-suppression strategies.
Participants assigned to the combined intervention additionally received 24 individually supervised electromyographic biofeedback-assisted pelvic floor muscle training sessions over 8 weeks. Surface perineal electrodes were used to provide visual feedback during pelvic floor muscle contractions. Training included slow and fast pelvic floor muscle contractions under the supervision of the same physiotherapist.
Assessments were performed at baseline and at week 8. The primary outcome was the change in mean daily voiding frequency calculated from a 3-day bladder diary. Secondary outcomes included daily urgency episodes, urgency urinary incontinence episodes, nocturia episodes, daily fluid intake, incontinence-related quality of life, the impact of urinary incontinence on daily activities, pelvic floor muscle strength, treatment satisfaction, intervention adherence, and adverse events.
The urologist performing the follow-up outcome assessments was blinded to treatment allocation. Participants and the treating physiotherapist could not be blinded because of the nature of the intervention.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Şahinbey
-
Gaziantep、Şahinbey、トルコ（Türkiye）、27010
- SANKO University Sani Konukoglu Application and Research Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Female participants aged 18 years or older
- Presence of wet overactive bladder symptoms
- Detrusor overactivity confirmed by urodynamic testing
- Pelvic floor muscle strength of at least 3/5 according to the Modified Oxford Scale
- Ability to comply with the study procedures and complete the bladder diary
Exclusion Criteria:
- Neurogenic bladder
- Active urinary tract infection or vulvovaginitis
- Pregnancy or planning pregnancy
- Urogynecological surgery within the previous 3 months
- Pelvic organ prolapse stage 2 or higher according to the Pelvic Organ Prolapse Quantification system
- Presence of a pacemaker or implantable defibrillator
- Recent conservative or pharmacological treatment for overactive bladder
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：Bladder Training
Participants assigned to this arm received an 8-week bladder training program including education, counseling on fluid intake and bladder irritants, timed voiding, progressive extension of voiding intervals, and urgency-suppression strategies.
|
An 8-week bladder training program including education on lower urinary tract anatomy and overactive bladder, counseling regarding fluid intake and bladder irritants, timed voiding, progressive extension of voiding intervals, and urgency-suppression strategies.
Voiding intervals were individualized according to the baseline bladder diary and gradually increased according to participant tolerance.
|
|
実験的：Bladder Training Plus EMG Biofeedback-Assisted Pelvic Floor Muscle Training
Participants assigned to this arm received the same 8-week bladder training program plus 24 individually supervised electromyographic biofeedback-assisted pelvic floor muscle training sessions delivered three times per week.
|
An 8-week bladder training program including education on lower urinary tract anatomy and overactive bladder, counseling regarding fluid intake and bladder irritants, timed voiding, progressive extension of voiding intervals, and urgency-suppression strategies.
Voiding intervals were individualized according to the baseline bladder diary and gradually increased according to participant tolerance.
An 8-week individually supervised pelvic floor muscle training program using surface electromyographic biofeedback.
Participants received three sessions per week for a total of 24 sessions.
Surface perineal electrodes provided visual feedback during isolated pelvic floor muscle contractions.
Each session included 40 slow contractions consisting of 10 seconds of contraction and 20 seconds of relaxation, followed by five sets of 10 fast contractions consisting of 1 second of contraction and 2 seconds of relaxation, with 2-minute rest periods between sets.
|
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 |
|---|---|---|
|
Change From Baseline in Mean Daily Voiding Frequency
時間枠：Baseline and week 8
|
Mean daily voiding frequency was calculated as the mean number of voids per day recorded in a 3-day bladder diary.
Change was calculated as the week-8 value minus the baseline value.
Negative change values indicate a reduction in daily voiding frequency.
|
Baseline and week 8
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Mean Daily Urgency Episodes
時間枠：Baseline and week 8
|
The mean number of urgency episodes per day was calculated from a 3-day bladder diary.
Change was calculated as the week-8 value minus the baseline value.
Negative change values indicate a reduction in urgency episodes.
|
Baseline and week 8
|
|
Change From Baseline in Mean Daily Urgency Urinary Incontinence Episodes
時間枠：Baseline and week 8
|
The mean number of urgency urinary incontinence episodes per day was calculated from a 3-day bladder diary.
Change was calculated as the week-8 value minus the baseline value.
Negative change values indicate a reduction in urgency urinary incontinence episodes.
|
Baseline and week 8
|
|
Change From Baseline in Mean Nightly Nocturia Episodes
時間枠：Baseline and week 8
|
The mean number of nocturia episodes per night was calculated from a 3-day bladder diary.
Change was calculated as the week-8 value minus the baseline value.
Negative change values indicate a reduction in nocturia episodes.
|
Baseline and week 8
|
|
Change From Baseline in Mean Daily Fluid Intake
時間枠：Baseline and week 8
|
Mean daily fluid intake was calculated in milliliters per day from a 3-day bladder diary.
Change was calculated as the week-8 value minus the baseline value.
|
Baseline and week 8
|
|
Change From Baseline in Incontinence Quality of Life Questionnaire Total Score
時間枠：Baseline and week 8
|
Incontinence-related quality of life was assessed using the 22-item Incontinence Quality of Life Questionnaire.
Total scores were transformed to a 0-to-100 scale, with higher scores indicating better quality of life.
Change was calculated as the week-8 score minus the baseline score.
Positive change values indicate improvement.
|
Baseline and week 8
|
|
Change From Baseline in Incontinence Impact Questionnaire-7 Total Score
時間枠：Baseline and week 8
|
The impact of urinary incontinence on daily life was assessed using the 7-item Incontinence Impact Questionnaire-7.
Total scores were transformed to a 0-to-100 scale, with higher scores indicating a greater negative impact.
Change was calculated as the week-8 score minus the baseline score.
Negative change values indicate improvement.
|
Baseline and week 8
|
|
Change From Baseline in Modified Oxford Scale Score
時間枠：Baseline and week 8
|
Pelvic floor muscle strength was assessed by digital vaginal palpation using the Modified Oxford Scale, ranging from 0 to 5. Higher scores indicate greater pelvic floor muscle strength.
Change was calculated as the week-8 score minus the baseline score.
Positive change values indicate improvement.
|
Baseline and week 8
|
|
Treatment Satisfaction Score
時間枠：Week 8
|
Treatment satisfaction was assessed using a 5-point Likert scale, ranging from 1, very dissatisfied, to 5, very satisfied.
Higher scores indicate greater treatment satisfaction.
|
Week 8
|
|
Number of Participants Who Completed the Treatment Program
時間枠：Week 8
|
Treatment completion was defined as completion of the assigned 8-week intervention program.
The number and percentage of participants completing treatment were recorded for each group.
|
Week 8
|
|
Number of Participants Who Completed the Week-8 Bladder Diary
時間枠：Week 8
|
The number and percentage of participants who provided a complete 3-day bladder diary at the week-8 assessment were recorded for each group.
|
Week 8
|
|
Number of EMG Biofeedback Sessions Attended
時間枠：Throughout the 8-week intervention period
|
For participants assigned to the combined intervention group, the number of supervised electromyographic biofeedback sessions attended was recorded out of 24 planned sessions.
|
Throughout the 8-week intervention period
|
|
Number of Participants With Adequate EMG Biofeedback Session Adherence
時間枠：Throughout the 8-week intervention period
|
Adequate adherence was defined as attendance at 75% or more of the 24 planned electromyographic biofeedback sessions, corresponding to at least 18 sessions.
The number and percentage of participants meeting this threshold were recorded.
|
Throughout the 8-week intervention period
|
|
Number of Participants With Adverse Events
時間枠：From baseline through week 8
|
Adverse events were monitored throughout the intervention period and recorded by event type and treatment group.
Events included electrode-site redness, transient perineal discomfort, post-exercise muscle fatigue, and transient worsening of urinary symptoms.
|
From baseline through week 8
|
協力者と研究者
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
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
- GIBTU-OAB-EMGBF-01
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
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
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。