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.

Study Overview

• Status: Active, not recruiting
• Conditions: Erectile Dysfunction; Erectile Dysfunction (ED)
• Intervention / Treatment: Drug: Sildenafil Oral Suspension Compared to Orodispersible Tablets

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Data from patients with ED attending the Andrology Outpatient Clinic of the Urology Department of the IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation will be retrospectively analyzed.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

group 1

Drug: Sildenafil Oral Suspension Compared to Orodispersible Tablets; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endpoint 1	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	from enrollment to the end of treatment

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: sildenafil; erectile dysfunction
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction
• Other Study ID Numbers: 6941

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No