Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

NCT06489431 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: 21120903
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Erectile Dysfunction; Penile Prosthesis; Complications, Infection or Inflammation

Keywords

Inflatable Penile Prosthesis; Irrisept

Outcome Measures

Primary Outcomes (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

  1-2 years

Study Arms (2)

Traditional Antibiotic Therapy

ACTIVE COMPARATOR

Preoperative 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.

Drug: Gentamicin; Drug: Rifampin

Irrisept only irrigation

EXPERIMENTAL

Preoperative 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.

Drug: Chlorhexidine

Interventions

Chlorhexidine DRUG

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

Also known as: Irrisept

Irrisept only irrigation

Gentamicin DRUG

Aminoglycoside antibiotic irrigation

Also known as: Gentak

Traditional Antibiotic Therapy

Rifampin DRUG

Antibacterial known to inhibit DNA-dependent RNA polymerase

Also known as: rifampicin, Rifadin

Traditional Antibiotic Therapy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Irrimaxcorp: collaborator
• Rush University Medical Center: lead
• Urological Surgeons of Northern California: collaborator

Study Sites (3)

Urological Surgeons of Northern California

Mountain View, California, 94035, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Uropartners Surgery Center

Des Plaines, Illinois, 60018, United States

Location

Related Publications (8)

• 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.

  PMID: 37158448 BACKGROUND

• 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.

  PMID: 33934664 BACKGROUND

• 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.

  PMID: 33521208 BACKGROUND

• 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.

  PMID: 34978511 BACKGROUND

• 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.

  PMID: 34109103 BACKGROUND

• 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.

  PMID: 33529773 BACKGROUND

• 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.

  PMID: 21521487 BACKGROUND

• 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.

  PMID: 39434728 DERIVED

Related Links

• irrisept home page

MeSH Terms

Conditions

Erectile Dysfunction; Infections; Inflammation

Interventions

Chlorhexidine; Gentamicins; Rifampin

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Aminoglycosides; Glycosides; Carbohydrates; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Edward Cherullo, MD

  Rush University

  PRINCIPAL INVESTIGATOR

• Laurence Levine, MD

  Rush University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be aware of the two options, however will be randomly selected to receive only one of the two treatments. Investigators will be aware of the treatment as they are administering it
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non inferiority trial

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: December 4, 2023
• Primary Completion: May 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact the noted research team

Locations

US (3)