Satisfaction of Patients With Erectile Dysfunction With the Use of Sildenafil Oral Suspension Compared to Orodispersible Tablets (SILOROS)
The goal of this observational retrospective study is to to evaluate treatment satisfaction with sildenafil oral suspension in patients with mild-to-moderate ED who were previously taking orodispersible sildenafil.
The secondary objective is to evaluate the efficacy and side effects of therapy with sildenafil oral suspension compared to orodispersible sildenafil.
Patients who took sildenafil orodispersible 50 mg for 3 months and subsequently took sildenafil oral suspension for another 3 months will be enrolled.
調査の概要
状態
詳細な説明
Erectile dysfunction (ED) is a very common condition affecting approximately 50% of men over 40. Numerous studies have shown that ED has a significant negative impact on a couple's quality of life and can lead to depressive symptoms and a loss of self-esteem. The first-line treatment for ED is phosphodiesterase type 5 inhibitors (PDE5 inhibitors). In Italy, four drugs are approved for the treatment of ED: sildenafil, tadalafil, vardenafil, and avanafil, each available in different formulations and dosages. Despite the wide variety of options, the dropout rate from ED therapy is very high. This is explained by the need for personalized therapy for each ED patient and by the demands of men not met by current medications on the market. Specifically, ED patients require treatment that is spontaneous, effective, and easily adjustable. These characteristics are often not met by the formulations and dosages of PDE5 inhibitors currently available. Tablet formulations, for example, are often associated with illnesses and are not always accepted by patients, especially those with swallowing difficulties. Furthermore, they cannot be precisely portioned in the event of dose de-escalation. Orodispersible films have poor palatability and are difficult to portion into equal portions. A new formulation of sildenafil in oral suspension was recently introduced to the Italian market. The oral suspension, consisting of sprays of 12.5 mg of sildenafil at a time, is intended to meet patient needs in terms of rapid onset, efficacy, and therapeutic modulation.
The primary objective is to evaluate treatment satisfaction with sildenafil oral suspension in patients with mild-to-moderate ED who were previously taking orodispersible sildenafil.
The secondary objective is to evaluate the efficacy and side effects of therapy with sildenafil oral suspension compared to orodispersible sildenafil.
Primary endpoint: Change in the total satisfaction domain score after 3 months of treatment with sildenafil oral suspension 50 mg as needed compared to previous treatment with sildenafil orodispersible 50 mg as needed.
Secondary endpoints will be:
- Difference in efficacy between treatments assessed by the erectile function domain score;
- Differences in the frequency of side effects;
- Change in the PGI-I score;
- Change in the PAIRS-SF score.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Milan、イタリア、20122
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age 18-75
- Male
- Sexually active (at least 2 sexual encounters per week)
- IIEF-EF between 11 and 25 at baseline
Exclusion Criteria:
- hypogonadism (total testosterone < 3.5 ng/mL)
- previous pelvic surgery
- ED on a neurogenic basis
- concomitant use of other ED therapies
- conical therapy with nitrates or other contraindicated drugs in combination with sildenafil
- hypersensitivity to the active ingredient
- patients for whom sexual activity is not recommended (e.g. patients with serious cardiovascular disorders, such as unstable angina or severe heart failure).
- patients who have lost vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION), whether or not this event was related to previous use of a phosphodiesterase type 5 (PDE5) inhibitor
- patients with severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal diseases, such as retinitis pigmentosa
- patients treated with guanylate cyclase stimulants, such as riociguat.
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
コホートと介入
グループ/コホート |
介入・治療 |
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group 1
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For the specific purpose of the study, only patients with mild-to-moderate ED (IIEF-EF 11-25) who had previously been treated with orodispersible sildenafil for 3 months will be considered. In accordance with the European Guidelines for Sexual Medicine, after 3 months of treatment, completion of a new IIEF questionnaire is required to assess the effect of treatment on symptoms and the Global Impression of Improvement (PGI-I) scale, as well as the PAIRS-SF questionnaire. Patients who, after at least 2 weeks of washout from orodispersible sildenafil, began treatment with sildenafil oral suspension for another 3 months will be selected and evaluated at the end of treatment with psychometric questionnaires. |
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 |
|---|---|---|
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Satisfaction measurement
時間枠：from enrollment to the end of treatment
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Change in the total satisfaction domain score after 3 months of treatment with sildenafil oral suspension 50 mg as needed compared to previous treatment with sildenafil orodispersible 50 mg as needed
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from enrollment to the end of treatment
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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 (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
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