Primary Care ERectile Function Outcome Registry for Men (PERFORM)

Nabiqasim Industries

Status: Not yet enrolling

Conditions: Erectile Dysfunction

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07356609

NQ/AP/SLR/Reg-007

Details and patient eligibility

About

The PERFORM registry is a structured, real-world data platform designed to systematically capture patient characteristics, disease severity and treatment patterns of Erectile Dysfunction (ED) across Pakistan. By reflecting routine clinical practice, an ED registry provides valuable insights into the disease epidemiology, unmet needs, and variations in care across populations. It supports evidence-based decision-making, helps identifying early predictors, and inform guideline development, health policy, and personalized management strategies in male sexual health.

Enrollment: 255 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult male above 18 years of age
2. Married
3. Diabetic
4. Patient reports erectile dysfunction (symptomatic).
5. Patient is eligible to be prescribed sildenafil by treating clinician.

Exclusion criteria

1. If at any other PDE-5 inhibitor (sildenafil, tadalafil, vardenafil, avanafil)

2. Concurrent use of organic nitrates (any form: glyceryl trinitrate, isosorbide mononitrate/dinitrate) - absolute contraindication

3. Recent or unstable cardiovascular disease

   • Myocardial infarction or stroke in last 3 months
   • Unstable angina
   • Uncontrolled arrhythmia or heart failure NYHA III-IV
   • Resting hypotension (SBP < 90 mmHg) or uncontrolled hypertension (SBP > 180 mmHg) per treating clinician
   • Known severe hepatic impairment or severe renal impairment on dialysis (if local clinician deems unsafe)
   • Known hypersensitivity to sildenafil or excipients
   • Concomitant use of potent CYP3A4 inhibitors (e.g., ritonavir) - unless clinician documents safe plan/dose adjustment