Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled Trial
Organic erectile failure is thought to be caused predominantly by neurogenic or vascular disorders. Venoocclusive dysfunction of the corpora cavernosa induces erectile dysfunction in 20-30% and appears clinically by premature erection loss.
The increased venous outflow from the corpora cavernosa can be illustrated as a so called 'venous leakage' by cavernosography being responsible for the therapeutical failure of intracavernously applied vasoactive substances. Cavernous smooth muscle pathology proven in some of the patients with venous leakage gave little hope to reconstructive surgery.
However, own examinations let assume that the etiology of 'venous leakage' is caused by endogenic and exogenic factors. Furthermore, reversible venous leakage was observed. Any therapeutic option of the veno-occlusive dysfunction showed disappointing results with a respective success rate of 20% in the long-term follow-up (surgical venous resection, percutaneous transpenile venous embolisms).
Finally the vacuum device or penile prosthetics are the only therapeutical option for the patients. Physiologically, bulbocavernous and ischiocavernous muscles increase the intracavernous pressure of the tumescent penis.
Regular pelvic floor exercise can be achieved by a physiotherapist which seems to be a time-consuming and expensive procedure, or an advantageous transcutaneous electrical stimulation which is the standard therapy for the treatment of posttraumatic atrophy of the striated muscular system.
Thus an external stimulator device has been developed to evaluate the therapeutical potency of striated muscle exercise in patients with erectile dysfunction. The present clinical study documents the first experiences with this EIS device and outlines its potency for the treatment of erectile dysfunction.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Menoufia
-
Shebin El-Kom、Menoufia、エジプト、32511
- Menoufia Faculty of Medicine
-
-
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:
- clinical diagnosis of erectile dysfunction for at least 6 months and confirmed with penile color doppler ultrasound
Exclusion Criteria:
- Patients with history of cardiovascular disease, contraindication for phosphodiesterase type 5 inhibitor, implanted cardiac pacemakers or defibrillators, anatomically significant penile deformities, active skin lesions at the electrode placement sites or any untreated endocrinal disorder that could affect the erectile function
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Sham-placebo
This group will receive Sham stimulation along with Placebo similar to tadalafil
|
Placebo resembling Tadalafil 5 mg oral tablet to be given once daily for 3 months
Electrical stimulation using PhalliMax system which delivers low-frequency and low-intensity TENS currents. The stimulation is intended to treat cavernous smooth muscle insufficiency by stimulating penile tissue to enhance blood flow. Self-adhesive electrodes were systematically applied on the patient according to a specific anatomical configuration: 1) Electrodes were placed on the lateral sides of the penile shaft or in a circumferential manner below the glans and at the penile root to target the corpora cavernosa. 2) Electrodes were placed on the perineum and suprapubic region to target the pelvic floor muscles. Patients were instructed to perform the stimulation sessions daily for a duration of 30 minutes for 3 months. Pulse frequency is set to 30 Hz, width to 85 microseconds a and stimulation cycles included stimulation phase for 3 seconds then rest phase for 6 seconds. Here patients will receive only one stimulation cycle for 3 seconds then output decline to zero. |
|
他の：Active-Placebo
This group will receive active stimulation along with Placebo similar to tadalafil
|
Placebo resembling Tadalafil 5 mg oral tablet to be given once daily for 3 months
Electrical stimulation using PhalliMax system which delivers low-frequency and low-intensity TENS currents.
The stimulation is intended to treat cavernous smooth muscle insufficiency by stimulating penile tissue to enhance blood flow.
Self-adhesive electrodes were systematically applied on the patient according to a specific anatomical configuration: 1) Electrodes were placed on the lateral sides of the penile shaft or in a circumferential manner below the glans and at the penile root to target the corpora cavernosa.
2) Electrodes were placed on the perineum and suprapubic region to target the pelvic floor muscles.
Patients were instructed to perform the stimulation sessions daily for a duration of 30 minutes for 3 months.
Pulse frequency is set to 30 Hz, width to 85 microseconds a and stimulation cycles included stimulation phase for 3 seconds then rest phase for 6 seconds.
|
|
他の：Sham-Tadalafil
This group will receive Sham stimulation along with tadalafil
|
Electrical stimulation using PhalliMax system which delivers low-frequency and low-intensity TENS currents. The stimulation is intended to treat cavernous smooth muscle insufficiency by stimulating penile tissue to enhance blood flow. Self-adhesive electrodes were systematically applied on the patient according to a specific anatomical configuration: 1) Electrodes were placed on the lateral sides of the penile shaft or in a circumferential manner below the glans and at the penile root to target the corpora cavernosa. 2) Electrodes were placed on the perineum and suprapubic region to target the pelvic floor muscles. Patients were instructed to perform the stimulation sessions daily for a duration of 30 minutes for 3 months. Pulse frequency is set to 30 Hz, width to 85 microseconds a and stimulation cycles included stimulation phase for 3 seconds then rest phase for 6 seconds. Here patients will receive only one stimulation cycle for 3 seconds then output decline to zero.
Tadalafil 5 mg oral tablet to be given once daily for 3 months
|
|
他の：Active-Tadalafil
This group will receive active stimulation along with tadalafil
|
Electrical stimulation using PhalliMax system which delivers low-frequency and low-intensity TENS currents.
The stimulation is intended to treat cavernous smooth muscle insufficiency by stimulating penile tissue to enhance blood flow.
Self-adhesive electrodes were systematically applied on the patient according to a specific anatomical configuration: 1) Electrodes were placed on the lateral sides of the penile shaft or in a circumferential manner below the glans and at the penile root to target the corpora cavernosa.
2) Electrodes were placed on the perineum and suprapubic region to target the pelvic floor muscles.
Patients were instructed to perform the stimulation sessions daily for a duration of 30 minutes for 3 months.
Pulse frequency is set to 30 Hz, width to 85 microseconds a and stimulation cycles included stimulation phase for 3 seconds then rest phase for 6 seconds.
Tadalafil 5 mg oral tablet to be given once daily 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 |
|---|---|---|
|
Peak systolic volume
時間枠：3 months
|
Measured in cm/s to assess the arterial inflow via Penile Color Doppler Ultrasound
|
3 months
|
|
End diastolic volume
時間枠：3 months
|
Measured in cm/s to evaluate the integrity of the veno-occlusive mechanism via Penile Color Doppler Ultrasound
|
3 months
|
|
Resistive index
時間枠：3 months
|
equals peak systolic volume - end diastolic volume / peak systolic volume, all measured via Penile Color Doppler Ultrasound
|
3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Erection Hardness Score
時間枠：3 months
|
a Doppler-related erection grading system with the following Grades: Grade0: Lack of response, Grade1: Mild tumescence, Grade2: Tumescence insufficient for penetration, Grade3: Rigidity sufficient for penetration and Grade4: Complete rigidity.
via Penile Color Doppler Ultrasound
|
3 months
|
|
IIEF-5 score
時間枠：3 months
|
The IIEF-5 questionnaire (International Index of Erectile Function) is a 5-item, validated tool used to diagnose the presence and severity of erectile dysfunction (ED) where Scores range from 5-25, with lower scores indicating more severe dysfunction
|
3 months
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Mohamed Alhefnawy、Urology Department, Benha University, Benha, Qalubia, Egypt
- 主任研究者：Islam Said、Urology Department, Benha University, Benha, Qalubia, Egypt
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
- TENS and Tadalafil in ED
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
米国で製造され、米国から輸出された製品。
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