Recruiting

Double-S

Sponsor:

Stanford University

Code:

NCT05451563

Conditions

Erectile Dysfunction

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Double-S

Study Details

Brief summary:

The purpose of this study is to use a minimally invasive erectile device for patients suffering from erectile dysfunction.

Conditions

Erectile Dysfunction

Study ID

NCT05451563

Start date

Mar 21, 2024

Status verified date

May, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • males >18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and/or radiation therapy for prostate cancer and or other pelvic malignancies affecting the sexual potency; emotional and psychological ED; organic vascular and/or metabolic ED etc.)
  • having a female partner willing to participate in the study

Exclusion Criteria:

  • not willing to attempt sexual vaginal intercourse with their partner
  • inability to wear/operate the external penile device for any reason

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Double-S arm

Participants will be asked to use the wearable penile device during intercourse.

Interventions

Double-S

Wearable device for intercourse

Primary outcome measure

  • Change in modified International Index of Erectile Dysfunction score [ Time Frame: baseline and up to 1 month post-baseline ]

Central Contacts and Locations

Central contacts

Satvir Basran

650-723-0948sbasran@stanford.edu

Locations

Stanford Healthcare, Stanford Hospital

Recruiting

Stanford, California, United States, 94304

More Information

Sponsor

Stanford University

Last update posted

May 22, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Stanford University on 2025-05-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.