Clinical trials: Penile Prosthesis
Erectile Dysfunction
Evaluation of the 2005 AMS (American Medical System) IPP (Inflatable Penile Prosthesis)
The purpose of this study is to evaluate modifications to the AMS 700 Series pump, cylinders, reservoir and rear tip extender design, their impact on ease of use for the patient, and ease of implantation for the physician.
- Trial name
- NCT00636506
- Testing
- AMS 700 IPP with MS Pump
- Where
- 7 sites in United States
- Volunteers
- 76 people
- Sponsor
- American Medical Systems
Post-COVID-19 Condition, Ulcerative Colitis
Emerging Indications for Hyperbaric Oxygen Treatment
This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric…
- Conditions
- Post-COVID-19 Condition, Ulcerative Colitis, Crohn Disease, Calciphylaxis
- Trial name
- NCT07240649
- Testing
- Hyperbaric oxygen treatment (HBOT), 100% Oxygen
- Volunteers
- 100 people
- Sponsor
- Jay C. Buckey Jr.
Erectile Dysfunction
Wound Healing Following Penile Prosthesis Implant
This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on men undergoing penile implant surgery for the first time.
- Trial name
- NCT05196191
- Testing
- VIAGENEX Max, Hibiclens wash
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- VIVEX Biologics, Inc.
Erectile Dysfunction, Intraoperative Complications
Patient Satisfaction and Complications With the New Titan® One Touch Release (OTR) Penis Prosthesis
The purpose of this study is to assess patient satisfaction with the Titan one touch release penis prosthesis and to register complications with this prosthesis.
- Conditions
- Erectile Dysfunction, Intraoperative Complications, Postoperative Complications
- Trial name
- NCT01378559
- Testing
- Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire
- Where
- Denmark
- Volunteers
- 26 people
- Sponsor
- Copenhagen University Hospital at Herlev
Erectile Dysfunction (ED)
IPP Placement & Intracavernosal Block
The inflatable penile prosthesis (IPP) is the gold standard for surgical management of erectile dysfunction (ED) and there is no consensus on the best postoperative pain management regimen.
- Trial name
- IPP (NCT07246642)
- Testing
- Exparel/bupivacaine mixture
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Wake Forest University Health Sciences
Erectile Dysfunction
Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant
The goal of this prospective randomized study is to demonstrate if the use of an external scrotal drainage in penile prosthetic surgery can reduce the risk of post-operative complications without increase the risk of infections.
- Trial name
- NCT06147791
- Testing
- External scrotal drainage
- Where
- 2 sites in Italy
- Volunteers
- 50 people
- Sponsor
- A.O.U. Città della Salute e della Scienza
Penile Prosthesis; Complications
Urethral Sterilization With Chlorhexidine Digluconate to Facilitate Primary Repair & Same-Session Implantation
The introduction of penile implants has revolutionized the management of male erectile dysfunction. However, a number of intraoperative complications may occur, which have a major impact on clinical outcomes and patient…
- Trial name
- NCT03614429
- Testing
- Chlorhexidine gel will be prepared according to an international product Instillagel®
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Cairo University
Penile Implant
A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery
This study will identify a patient population who wishes to address a variety of concerns about the size, shape, or appearance of their penis with the placement of a subcutaneous Silicone Block Penile Implant.
- Trial name
- NCT04985123
- Testing
- Pre-Formed Penile Silicone Block Implant
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- International Medical Devices, Inc.
Erectile Dysfunction
Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction
Prospective collection of pre-defined parameters on the surgical treatment of male erectile dysfunction using Penile Prosthesis Implants (PPIs).
- Trial name
- PHOENIX (NCT03849586)
- Where
- 30 sites in Belgium, France and 6 more
- Volunteers
- 1,076 people
- Sponsor
- European Association of Urology Research Foundation
Erectile Dysfunction
Titan® One Touch Release Inflatable Penile Prosthesis
The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.
- Trial name
- NCT00731939
- Testing
- Inflatable Penile Prosthesis
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 124 people
- Sponsor
- Coloplast A/S
Erectile Dysfunction, Penile Prosthesis Infection
Collaborative Urological Prosthetics Investigation Directive Research Group
The purpose of this study is to determine if an additional 6 days of oral antibiotics decreases the risk of penile prosthesis infection after implantation.
- Trial name
- CUPID (NCT05100654)
- Testing
- Doxycycline, Ciprofloxacin, Augmentin
- Where
- United States
- Volunteers
- 800 people
- Sponsor
- University of Chicago
To Try to Eliminate Frequencies of Insertions in Order to Arrive to Adequate Size of Implanted Penile Prosthesis
Tumescent Stretching Measurement Technique
Introducing and evaluating the accuracy of a novel method for estimating inflatable penile prosthesis cylinders length by stretching the tumesncent penis intraoperatively instead of taking proximla and distal measurement to the…
- Trial name
- TSMT (NCT04864301)
- Testing
- Tumescent Stretching Measurement Technique
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cairo University
Transgenderism, Erectile Dysfunction
Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.
Transgender and gender diverse (TGD) individuals most often choose for phalloplasty as a means to create masculine external genitalia.
- Conditions
- Transgenderism, Erectile Dysfunction, Prosthesis Durability, Gender Dysphoria
- Trial name
- EROS (NCT05883553)
- Testing
- Usability and added value of device within sexual activity
- Where
- 2 sites in Belgium, Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University Hospital, Ghent
Erectile Dysfunction, Penile Prosthesis; Complications, Infection or Inflammation
Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement
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.
- Trial name
- NCT06489431
- Testing
- Chlorhexidine, Gentamicin, Rifampin
- Where
- 3 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
Erectile Dysfunction, Erectile Dysfunction Following Radical Prostatectomy
Penile Implant Intraoperative Measurements Planning Chart
This is a chart of penile size measurements where penile length and width are recorded intra-operatively prior to penile prosthesis implantation to guide the surgeon to the correct and adequate post-operative penile size
- Conditions
- Erectile Dysfunction, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction With Diabetes Mellitus, Erectile Dysfunction Due to Arterial Disease
- Trial name
- PIIMP (NCT05531877)
- Testing
- Penile Prosthesis Implantation
- Where
- 2 sites in Egypt
- Volunteers
- 200 people
- Sponsor
- Cairo University
Erectile Dysfunction (ED)
Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction
This study evaluates the long-term safety and effectiveness of the Rigicon Infla10® Inflatable Penile Prosthesis in patients with erectile dysfunction.
- Trial name
- UNITED (NCT07273773)
- Testing
- Rigicon Infla10® Inflatable Penile Prosthesis (IPP)
- Where
- 4 sites in United States
- Volunteers
- 182 people
- Sponsor
- Rigicon, Inc.