UnknownNot Applicable

Next Generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes

United States40 participantsStarted 2021-10-27

Plain-language summary

Randomized prospective study to evaluate next generation sequencing (NGS) and standard-of-care culture for clinically infected penile implants and to compare outcomes with identification of microbes.

Who can participate

Age range18 Years – 80 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male penile prosthesis patients * Age range: 18-80 * Within 6 months of penile prosthesis surgery * At least 1 of the following: Device part stuck to thinning skin, any drainage from the wound site, massive red and swollen genitalia parts, exposed penile prosthesis parts, draining open tract, draining hematoma Exclusion Criteria: * Transgender / neophallus * Not able to communicate or follow up well, or non-compliant * Less than 18 or more than 80 years old * Active addiction * Main issue is implant pain

What they're measuring

Device survival rates by calculating by incidence of implant freely mobile and working without tenderness

Timeframe: 2 years

Patient satisfaction of penile prosthesis

Timeframe: 2 years

Trial details

NCT IDNCT05287438

SponsorMicroGenDX

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-31

View on ClinicalTrials.gov More Penile Implantation trials