Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
NCT ID:
NCT04801368
Eligibility Criteria:
Inclusion Criteria:
* Men undergoing 3-piece penile prosthesis placement under general anesthesia at Mayo Clinic - Rochester.
* ≥ 18 years old.
Exclusion Criteria:
* History of opioid exposure within the preceding 90 days prior to surgery (based on patient-report, review of the electronic medical record, and NMP prescribing database review)
* Current or prior history of alcohol or drug abuse (illicit or prescription)
* History of chronic pain conditions (chronic musculoskeletal pain, fibromyalgia, central sensitization, chronic pelvic pain syndrome, etc.)
* History of cardiac arrhythmia or untreated severe cardiovascular disease
* Uncontrolled hypertension
* Hepatic insufficiency
* Renal insufficiency (CKD stage IIIa or greater)
* Current anti-platelet or anti-coagulation therapy with plans to continue at the time of prosthesis placement
* Poorly controlled diabetes mellitus (defined as HgbA1c \> 8.5 within 30 days of surgery)
* Concurrent adjunctive operative procedures planned at the time of penile prosthesis placement (examples: male urethral sling, Peyronie's disease straightening with penile plication or incision/grafting)
* Concurrent non-prosthetic surgery planned at the time of penile prosthesis placement (examples: circumcision, hernia repair, hydrocelectomy, etc.)
* Planned infrapubic or subcoronal incision at the time of penile prosthesis placement
* Patients who will be undergoing prosthesis placement using local, monitored, or spinal anesthesia (i.e. non-general anesthesia)
* Allergy or history of intolerance to any local anesthetic agents included in the protocol
* History of prior penile prosthesis or artificial urinary sphincter surgery
* Revision penile prosthesis surgery
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04801368
Study Brief:
Protocol Section:
NCT04801368