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IPP Placement & Intracavernosal Block

Study acronym: IPP
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 32 days later Sep 2027 → Nov 2027
See other at-risk trials from Wake Forest University Health Sciences

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: Sep 2026 to Nov 2026 Show 5 more changesShow less
    • Primary completion pushed from Sep 2027 to Nov 2027
    • Study completion date: Oct 2027 to Nov 2027
    • Interventions: Exparel/bupivacaine mixture (Drug) to Exparel/bupivacaine mixture (Drug)
    • Secondary endpoints: details revised at 4 of 6 entries
    • Eligibility criteria expanded, about 5 words
  2. Start date: May 2026 to Sep 2026v5
  3. Start date: Mar 2026 to May 2026
    • Primary completion pushed from Jul 2027 to Sep 2027
    • Study completion pushed from Aug 2027 to Oct 2027
    v4
  4. Start date: Jan 2026 to Mar 2026v3
  5. Start date: Dec 2025 to Jan 2026
    • Site contact updated
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. In the wake of the opioid epidemic, postoperative pain management is heavily scrutinized. The National Institute of Health estimated over 81,000 individuals died following overdose of any opioids in 2022 alone; of these, over 14,000 deaths were linked to prescription opioids. Thus, strategies to minimize postoperative pain should not only improve patient experience but also lessen the need to escalate to opioid usage.
Trial Details
NCT Number NCT07246642
Lead Sponsor Wake Forest University Health Sciences
Conditions
(from sponsor)		 Erectile Dysfunction (ED)
Related terms Agnosia, Erectile Dysfunction
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov