Phase 2 Prostate Cancer Trial, Recruiting NCT06161506 Sponsor: National Cancer Institute (NCI) Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06161506
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Participants must be male.
  • Participants must have had urinary leakage or loss of bladder control for at least 6 months after receiving treatment for prostate cancer (such as surgery or radiation).
  • Participants must experience at least one of the following: leaking urine during physical activity, sneezing, or coughing; or feeling a sudden, strong urge to urinate that is hard to hold back.
  • Participants must have moderate urinary leakage, meaning they use between 1 and 4 incontinence pads per day.
  • Participants must be able to read and write in English.
  • Participants must be 18 years of age or older.
  • Participants must have a general health and activity level that meets a standard medical scoring system called the ECOG scale, at a level of 2 or below — meaning they are able to care for themselves and are up and about for more than half of their waking hours (confirm with trial site).
  • Participants must be willing and able to understand and sign a written consent form.

Who may not be able to join:

  • People who have a planned change to their prostate cancer treatment during the study period.
  • People who have a history or current symptoms of being unable to empty their bladder (unless this happened before prostate surgery), leaking urine from somewhere other than the urethra, or leaking due to an overfull bladder.
  • People who have an active urinary tract infection at the time of screening, or who have had 4 or more urinary tract infections in the 12 months before the study begins.
  • People who have a history of complete loss of nerve function to the pelvic floor muscles.
  • People with severe obesity, defined as a body mass index (BMI) over 35.
  • People who experience ongoing pelvic pain or painful bladder symptoms.
  • People who have a metal implant in the abdominal or pelvic area.
  • People who have a history of ongoing chronic cough.
  • People who have an implanted heart device, an untreated irregular heart rhythm, or other significant heart problems.
  • People who have a history of epilepsy.
  • People who have a known nerve or muscle condition that could be contributing to their urinary leakage.
  • People who have had a change in medication for urinary leakage within 2 weeks before the study begins.
  • People with other serious ongoing illness, or personal circumstances that might make it difficult to follow the study requirements.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Deborah E Citrin, M.D., National Cancer Institute (NCI)

Phone: (240) 858-3103

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
15 February 2024
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To describe the efficacy of the Elidah device treatment on male urinary incontinence

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov