Clinical trials: Penile Prosthesis
Erectile Dysfunction
Randomized Trial of Ropivacaine & Bupivacaine for Inflatable Penile Prosthesis
The purpose of this research is to determine the effects of penile ring block for local anesthesia with liposomal bupivacaine vs ropivacaine mixture in subjects undergoing surgery for Penile Prosthesis Placement.
- Trial name
- ROVEX-IPP (NCT04801368)
- Testing
- Randomization of two local anesthetics.
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Transgenderism, Erectile Dysfunction
Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons
This study aims to explore sexual satisfaction among transgender men and their partners following the placement of erectile prostheses after phalloplasty.
- Conditions
- Transgenderism, Erectile Dysfunction, Prosthesis Durability, Gender Dysphoria
- Trial name
- NCT06639776
- Testing
- Questionnaire
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- University Hospital, Ghent
Erectile Dysfunction
Penile Lengthening Pre-Penile Prosthesis Implantation
This study is intended to utilize a novel, class I (ie. lowest risk, clinical studies not required) medical device to determine whether penile length can be increased in men prior to undergoing a penile prosthesis implantation…
- Trial name
- NCT03500406
- Testing
- RestoreX, Control
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Mayo Clinic
Erectile Dysfunction, Gender Dysphoria
ZEPHYR: A Study Evaluating Surgical Outcome After Implantation of the Zephyr ZSI 475 FTM Inflatable Penile Implant in the Neophallus After Female-to-male Sex Reassignment Surgery
This study will look into the surgical outcome after implantation of the Zephyr ZSI 475 FTM in the neophallus.
- Trial name
- NCT04064671
- Testing
- Implantation of the Zephyr ZSI 475 FTM erectile implant
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- University Hospital, Ghent
Penile Implantation
Prosthetics Registry and Outcomes in Urology at Duke
To establish the Prosthetics Registry and Outcomes in Urology at Duke (PROUD) which will serve as a retro- and prospective data repository that our team will use to optimize patient satisfaction, lower cost and reduce morbidity…
- Trial name
- PROUD (NCT03323645)
- Where
- United States
- Volunteers
- 190 people
- Sponsor
- Duke University
Surgery, Satisfaction
Inflatable Penile Prostheses : Which Patients Can Correctly Use the Scrotal Pump ?
Sexual health and satisfaction are well know as critical critera to assess quality of life, at any age. Among the multiple aspects of sexual health, erectile dysfunction (ED) is not anymore a fate, mainly thanks to the advent of…
- Conditions
- Surgery, Satisfaction, Penile Prosthesis; Complications
- Trial name
- NCT04390230
- Testing
- Penile prostheses implantation
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Transgenderism, Erectile Dysfunction
Erectile Aid Use in Post-phalloplasty and Post-metoidioplasty Transgender Patients
This study seeks to explore the various methods used by transgender men for sexual intercourse following phalloplasty or metoidioplasty, focusing on their satisfaction with different erectile aids, as well as the satisfaction of…
- Conditions
- Transgenderism, Erectile Dysfunction, Gender Dysphoria, Sexual Dysfunction
- Trial name
- AID (NCT06639763)
- Testing
- Questionnaire
- Where
- Belgium
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University Hospital, Ghent
Erectile Dysfunction, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
A Tissue Sparing, Laser Assisted Penile Prosthesis Implantation Technique
A surgical technique using laser assisted penile prosthesis implantation
- Conditions
- Erectile Dysfunction, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, Erectile Dysfunction Due to Arterial Disease, Erectile Dysfunction Due to Arterial Insufficiency
- Trial name
- TSLA (NCT06743048)
- Testing
- Tissue Sparing Laser Implantation
- Where
- Egypt
- Volunteers
- 7 people
- Sponsor
- Cairo University
Malignant Neoplasms of Male Genital Organs
Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis
During penile prosthesis surgery, patients are given general anesthesia in combination with other pain drugs. A caudal nerve block (CNB) is a local anesthetic injected near the tailbone, in addition to general anesthesia, which…
- Trial name
- NCT02740127
- Testing
- Caudal Nerve Block (CNB), Ropivacaine, Epinephrine
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- M.D. Anderson Cancer Center
Transsexualism, Surgery
Use of an External Erectile Device in Transgender Man Following Phalloplasty
The purpose of this study is to test whether an external erectile prosthesis (The Elator™) is a feasible alternative to internal erectile prostheses for transgender men who have undergone a phalloplasty with glansplasty and wish…
- Conditions
- Transsexualism, Surgery, Sex Behavior, Erectile Dysfunction
- Trial name
- ProstHEsis (NCT03823014)
- Testing
- Elator
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Surgery for Sacral Nerve Neurostimulation, Surgery for Urinary Artificial Sphincter
Medico-economical Evaluation of Patient-hotel in Urology
This is a medico-economic study of outpatient surgery paired with a night stay in a patient-hotel, compared with a conventional hospitalization for three types of urological surgeries.
- Conditions
- Surgery for Sacral Nerve Neurostimulation, Surgery for Urinary Artificial Sphincter, Surgery for Prosthetic Penile Implant
- Trial name
- HOTELAMBU (NCT02890017)
- Testing
- postoperative hotel, conventional hospitalization
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Hospices Civils de Lyon
Erectile Dysfunction, Impotence
PROPPER Prospective Registry of Outcomes With Penile Prosthesis
The purpose of this observational registry is to collect and better understand "real-world" outcomes for men undergoing penile implant surgery to treat erectile dysfunction.
- Trial name
- PROPPER (NCT01383018)
- Testing
- AMS Penile Prosthesis Devices
- Where
- 11 sites in United States, Canada
- Volunteers
- 1,457 people
- Sponsor
- Boston Scientific Corporation
Erectile Dysfunction
Cavernous Tissue Preservation During Penile Prosthesis Implantation
Spontaneous penile tumescence after penile prosthesis implantation has been previously reported as sporadically occurring during implant surgery.
- Trial name
- CTP (NCT03733860)
- Testing
- Cavernous tissue sparing penile prosthesis implantation, Conventional penile prosthesis implantation, Intracavernosal injection of alprostadil
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Cairo University
Penile Implant
Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery
This is a retrospective evaluation of all subjects who successfully received implantation of the Silicone Block for correction of soft tissue deformities of the penis.
- Trial name
- NCT02477189
- Testing
- Silicone Block
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- International Medical Devices, Inc.
Penile Prosthesis
Evaluation of Penile Prosthesis Pump Manipulation
Erectile dysfunction is a highly prevalent pathology. When oral or injectable pharmacological treatments prove ineffective, the treatment of choice is penile prosthesis which provides the possibility of sexual activity with…
- Trial name
- ECM3P (NCT06376513)
- Testing
- Evaluation
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Hospices Civils de Lyon
Penile Prosthesis Infection, Penile Prosthesis; Complications, Infection or Inflammation
Minimally Invasive Scrotal Incision for Penile Prosthesis Implantation, Novel Technique.
The main goals of this study are to examine the superiority of this novel technique and its acceptance by patients with ED candidate for PPI and compare these results with data available in the literature for ordinary…
- Trial name
- PPI (NCT05558163)
- Testing
- transverse scrotal approach for PPI, penoscrotal approach for PPI
- Volunteers
- 200 people
- Sponsor
- Al-Azhar University
Erectile Dysfunction
Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)
This study evaluates the long-term safety and efficacy of the use of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis in patients with erectile dysfunction.
- Trial name
- ERASE-ED (NCT05574868)
- Testing
- Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis
- Where
- 7 sites in Australia
- Volunteers
- 182 people
- Sponsor
- Rigicon, Inc.
Erectile Dysfunction
Penile Prosthesis in Patients With Erectile Dysfunction
Erectile dysfunction (ED) is defined as the persistent inability to attain and or maintain an erection sufficient to permit satisfactory sexual performance
- Trial name
- NCT03466619
- Testing
- inflatable penile prosthesis (IPP)
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Tanta University
Erectile Dysfunction
Penile Lengthening Pre-Penile Prosthesis Implantation
The goal of this study is to determine whether or not the use of a penile traction therapy device known as RestoreX prior to implantation of a penile prosthesis can increase the length of the implant used during surgery.
- Trial name
- NCT07053826
- Testing
- Penile Traction Device, Inflatable Penile Prosthesis Implantation
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- J. Peter Rubin, MD
Penile Implantation, Infections
Next Generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes
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.
- Trial name
- NCT05287438
- Testing
- Next-Generation DNA Sequencing, Standard Culture
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- MicroGenDX