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Erectile DysfunctionPhase 3NCT06489431

Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

A Phase 3 study testing Chlorhexidine, Gentamicin and Rifampin in people with Erectile Dysfunction and Penile Prosthesis; Complications, Infection or Inflammation, run by Rush University Medical Center at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to assess whether intraoperative irrigation with Irrisept is not inferior to irrigation with multiple antibiotics during placement of a first time inflatable penile prosthesis device. Read more about this study

Who is it for?
Any age, men onlyHealthy volunteers can take part
What is being tested?
Chlorhexidine, Gentamicin and Rifampin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
3 sitesUnited States
Study dates
4 Dec 2023to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Inclusion criteria include all men undergoing penile prosthesis (any manufacturer) implantation (inpatient or outpatient)

Who cannot join

  • Exclusion criteria include men who are having revision implant surgeries, men who may require intraoperative complex reconstruction including graft for Peyronie's Disease, and transgender males

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Uropartners Surgery Center

    Des Plaines, Illinois, 60018

  • Urological Surgeons of Northern California

    Mountain View, California, 94035

Other trials in United States

About this study

Official title: Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement: A Prospective Non-inferiority Trial

The purpose of this study is to assess whether intraoperative irrigation with Irrisept is not inferior to irrigation with multiple antibiotics during placement of a first time inflatable penile prosthesis device.

Read the detailed description

To conduct a prospective, randomized, controlled trial of all virgin penile prosthesis implantations with the goal of assessing Irrisept's candidacy as an alternative to traditional antibiotic irrigation (Rifampin, Gentamicin for all patients, with the addition of Amphotericin B if patient has a history of diabetics) during penile prosthesis surgery. The investigators believe that Irrisept provides adequate antibacterial and antifungal coverage to serve as an alternative to traditional antibiotic therapy. Additionally, the investigators believe a cost analysis would support the use of Irrisept in the event that non-inferiority is demonstrated.

Being tested
Chlorhexidine, Gentamicin, Rifampin
Keywords
Inflatable Penile Prosthesis, Irrisept
Medical subject headings
Erectile Dysfunction, Infections, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChlorhexidineDrug

    Also called Irrisept

    Irrisept is a self-contained jet lavage that contains chlorhexidine gluconate (CHG) as a preservative to offer broad-spectrum activity against various microorganisms in the bottled solution

  • GentamicinDrug

    Also called Gentak

    Aminoglycoside antibiotic irrigation

  • RifampinDrug

    Also called rifampicin, Rifadin

    Antibacterial known to inhibit DNA-dependent RNA polymerase

Study groups in NCT06489431
Study groupRoleWhat they receive
Traditional Antibiotic TherapyActive comparatorPreoperative antibiotic selection, method or preparation, draping, or technique;. the corpora, scrotum, and reservoir space will be irrigated with traditional antibiotics (rifampin, gentamycin, +/-fluconazole) immediately after the space is created in all cases. An additional scrotal irrigation with traditional antibiotics after all components are placed will be performed, as well. The patients will be followed and monitored for penile prosthesis infection as well as any other surgical complications for 1 year post operatively.
Receives: Drug: Gentamicin; Drug: Rifampin
Irrisept only irrigationExperimentalPreoperative antibiotic selection, method or preparation, draping, or technique;. the corpora, scrotum, and reservoir space will be irrigated with Irrisept only immediately after the space is created in all cases. An additional scrotal irrigation with Irrisept only after all components are placed will be performed, as well. The patients will be followed and monitored for penile prosthesis infection as well as any other surgical complications for 1 year post operatively.
Receives: Drug: Chlorhexidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infection Rate of Patients Receiving Traditional Antibiotic Irrigation vs Irrisept Only

    All patients will be closely followed with appointments at regular intervals for the first year after surgery to monitor for infections as per usual care

    Measured: 1-2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study start4 Dec 2023
  3. Primary completion31 May 2026
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Model description
Non inferiority trial
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06489431
Sponsor's protocol ID
21120903
Status last verified
Jul 2026
First submitted
28 Jun 2024
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data obtained through this study may be provided to qualified researchers with academic interest in IPP placement. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

Publications

  • Karpman E, Griggs R, Twomey C, Henry GD. Dipping Titan implants in Irrisept solution (0.05% chlorhexidine gluconate) and exposure to various aerobic, anaerobic, and fungal species. J Sex Med. 2023 Jun 28;20(7):1025-1031. doi: 10.1093/jsxmed/qdad055.

    PubMed 37158448

  • O'Donnell JA, Wu M, Cochrane NH, Belay E, Myntti MF, James GA, Ryan SP, Seyler TM. Efficacy of common antiseptic solutions against clinically relevant microorganisms in biofilm. Bone Joint J. 2021 May;103-B(5):908-915. doi: 10.1302/0301-620X.103B5.BJJ-2020-1245.R2.

    PubMed 33934664

  • Markel JF, Bou-Akl T, Dietz P, Afsari AM. The Effect of Different Irrigation Solutions on the Cytotoxicity and Recovery Potential of Human Osteoblast Cells In Vitro. Arthroplast Today. 2021 Jan 19;7:120-125. doi: 10.1016/j.artd.2020.11.004. eCollection 2021 Feb.

    PubMed 33521208

  • O'Donnell JA, Wu M, Cochrane NH, Belay E, Myntti MF, James GA, Ryan SP, Seyler TM. Efficacy of Common Antiseptic Solutions Against Clinically Relevant Planktonic Microorganisms. Orthopedics. 2022 Mar-Apr;45(2):122-127. doi: 10.3928/01477447-20211227-05. Epub 2022 Jan 3.

    PubMed 34978511

  • Siddiqi A, Abdo ZE, Springer BD, Chen AF. Pursuit of the ideal antiseptic irrigation solution in the management of periprosthetic joint infections. J Bone Jt Infect. 2021 May 26;6(6):189-198. doi: 10.5194/jbji-6-189-2021. eCollection 2021.

    PubMed 34109103

  • Kia C, Cusano A, Messina J, Muench LN, Chadayammuri V, McCarthy MB, Umejiego E, Mazzocca AD. Effectiveness of topical adjuvants in reducing biofilm formation on orthopedic implants: an in vitro analysis. J Shoulder Elbow Surg. 2021 Sep;30(9):2177-2183. doi: 10.1016/j.jse.2020.12.009. Epub 2021 Jan 30.

    PubMed 33529773

  • Wosnitzer MS, Greenfield JM. Antibiotic patterns with inflatable penile prosthesis insertion. J Sex Med. 2011 May;8(5):1521-8. doi: 10.1111/j.1743-6109.2011.02207.x. Epub 2011 Feb 24.

    PubMed 21521487

  • Desouky E, Tsambarlis P, Levine LA. Comparing 0.05% chlorhexidine gluconate monotherapy to conventional antibiotic irrigation in de-novo penile prosthesis implantation: a two-center prospective randomized controlled non-inferiority study (preliminary results). Transl Androl Urol. 2024 Sep 30;13(9):1905-1911. doi: 10.21037/tau-24-278. Epub 2024 Sep 26.

    PubMed 39434728

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chlorhexidine, Gentamicin and Rifampin in people with Erectile Dysfunction and Penile Prosthesis; Complications, Infection or Inflammation, run by Rush University Medical Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infection Rate of Patients Receiving Traditional Antibiotic Irrigation vs Irrisept Only (time frame: 1-2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06489431, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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