Pelvic Floor Therapies for Lifelong Premature Ejaculation (PE-PFMT)
Electromagnetic Pelvic Floor Stimulation Versus Biofeedback-Assisted and Conventional Pelvic Floor Muscle Training in Men With Lifelong Premature Ejaculation: A Randomized Controlled Trial
調査の概要
状態
詳細な説明
Premature ejaculation is one of the most common male sexual dysfunctions and may negatively affect quality of life, sexual satisfaction, and interpersonal relationships. Pelvic floor muscles, particularly the bulbocavernosus and ischiocavernosus muscles, are involved in ejaculatory control. Pelvic floor muscle training has been used as a non-pharmacological treatment for premature ejaculation; however, its effectiveness may be limited by incorrect muscle identification and poor adherence. Biofeedback-assisted pelvic floor muscle training may improve patient awareness and neuromuscular coordination. Electromagnetic pelvic floor stimulation is a non-invasive modality designed to induce repeated pelvic floor muscle contractions and may improve pelvic floor muscle function.
After approval by the Research Ethics Committee, Faculty of Medicine, Tanta University, eligible participants will be recruited from the outpatient clinic of the Urology Department, Tanta University. Men aged 18 to 50 years with lifelong premature ejaculation and intravaginal ejaculatory latency time of less than 1 minute will be enrolled after providing written informed consent. Participants will be randomly assigned in a 1:1:1 ratio to receive electromagnetic pelvic floor stimulation, biofeedback-assisted pelvic floor muscle training, or conventional pelvic floor muscle training.
Baseline assessment will include medical and sexual history, physical examination, stopwatch-measured intravaginal ejaculatory latency time, Premature Ejaculation Diagnostic Tool score, International Index of Erectile Function-5 score, patient-reported ejaculatory control, sexual satisfaction, and partner satisfaction. Intravaginal ejaculatory latency time will be calculated as the average of at least three consecutive intercourse attempts. Outcomes will be assessed at baseline, at the end of treatment at 6 weeks, and at 3-month follow-up. Treatment adherence and adverse events will be recorded throughout the study.
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：Hany F Badawy, MD
- 電話番号：+201149525028
- メール：HANYFATHY86@GMAIL.COM
研究連絡先のバックアップ
- 名前：Mohamed I Elmaadawy, MD
- 電話番号：+201060245430
- メール：Mohamed.elmaadawy@med.tanta.edu.eg
研究場所
-
-
Tanta
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Tanta、Tanta、エジプト
- 募集
- Department of Urology- Tanra University Hospitals
-
コンタクト：
- Mohamed I Elmaadawy, MD
- 電話番号：+201060245430
- メール：Mohamed.elmaadawy@med.tanta.edu.eg
-
-
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:
- Men aged 18 to 50 years.
- Diagnosis of lifelong premature ejaculation.
- Intravaginal ejaculatory latency time less than 1 minute.
- Ability and willingness to comply with the treatment protocol and follow-up visits.
- Written informed consent.
Exclusion Criteria:
- Erectile dysfunction.
- Neurological disease.
- Previous pelvic surgery.
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 |
|---|---|
|
実験的：Electromagnetic Pelvic Floor Stimulation
Participants allocated to this arm will receive non-invasive electromagnetic pelvic floor stimulation over a 6-week treatment period according to the institutional pelvic floor rehabilitation protocol.
|
Non-invasive electromagnetic pelvic floor stimulation will be applied to induce repeated pelvic floor muscle contractions.
Treatment will be delivered over 6 weeks according to the institutional pelvic floor rehabilitation protocol.
|
|
アクティブコンパレータ：Biofeedback-Assisted Pelvic Floor Muscle Training
Participants allocated to this arm will receive supervised pelvic floor muscle training assisted by biofeedback over a 6-week treatment period to improve pelvic floor muscle awareness, contraction, relaxation, and coordination.
|
Participants will receive supervised pelvic floor muscle training assisted by biofeedback over a 6-week treatment period to improve pelvic floor muscle awareness, contraction, relaxation, and coordination.
|
|
アクティブコンパレータ：Conventional Pelvic Floor Muscle Training
Participants allocated to this arm will receive conventional pelvic floor muscle training over a 6-week treatment period according to the institutional pelvic floor rehabilitation protocol.
|
Participants will receive conventional pelvic floor muscle training aimed at improving pelvic floor muscle control and ejaculatory control.
Treatment will be delivered over 6 weeks according to the institutional physiotherapy protocol.
|
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 in Intravaginal Ejaculatory Latency Time at 6 Weeks
時間枠：Baseline and 6 weeks
|
Intravaginal ejaculatory latency time will be measured using a stopwatch.
The average of at least three consecutive intercourse attempts will be recorded.
The outcome will be expressed as the change in intravaginal ejaculatory latency time from baseline to the end of treatment at 6 weeks.
|
Baseline and 6 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Intravaginal Ejaculatory Latency Time at 3 Months
時間枠：Baseline and 3 months
|
Intravaginal ejaculatory latency time will be measured using a stopwatch.
The average of at least three consecutive intercourse attempts will be recorded.
The outcome will be expressed as the change from baseline to 3-month follow-up.
|
Baseline and 3 months
|
|
Change in Premature Ejaculation Diagnostic Tool Score at 6 Weeks
時間枠：Baseline and 6 weeks
|
The Premature Ejaculation Diagnostic Tool will be used to assess the severity of premature ejaculation.
The outcome will be expressed as the change in total score from baseline to 6 weeks.
|
Baseline and 6 weeks
|
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Change in Patient-Reported Ejaculatory Control at 6 Weeks
時間枠：Baseline and 6 weeks
|
Patient-reported ejaculatory control will be assessed using a Likert scale.
The outcome will be expressed as the change from baseline to 6 weeks.
|
Baseline and 6 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Mohamed I Elmaadawy, MD、Tanta University
研究記録日
主要日程の研究
研究開始 (実際)
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
- PEPFMT36265PR25426
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
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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