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Study Summary
This trial is testing a new device to see if it is safe and effective in relieving symptoms of a common prostate problem.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am taking medication that affects bladder function.My prostate size and urethral length fit the required measurements.I have a condition that could cause difficulty in emptying my bladder.I have had issues with narrowing in my urinary tract needing multiple treatments.I have taken phenylephrine or pseudoephedrine within the last 24 hours.I have bladder stones along with my current condition.I have had surgery or other invasive treatments on my prostate.I have not taken 5-alpha-reductase inhibitors in the last 3 months.I have been in a normal hormonal state for 6 months while on androgens.I am 45 years old or older.I can't fully empty my bladder, leaving at least 125 ml of urine.My PSA level is above 10 ng/mL or I might have prostate cancer.I have had radiation or major surgery in my pelvic area before.I have a history of diseases that affect my ability to urinate.I have been taking specific medications like alpha-blockers or anticholinergics recently.I cannot stop my blood thinners for 3 days, or coumadin for 5 days, before a procedure.I have tried and cannot tolerate medication for urinary symptoms, or I chose not to take them.I had a UTI but it's treated now, or I've had 2 or more UTIs in the past year.My prostate condition is considered untreatable by my doctor.I have had chronic or recurring prostatitis in the last year.
- Group 1: Treatment Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many research participants have joined this experiment?
"That is correct. According to clinicaltrials.gov, this medical research was first unveiled on February 9th 2021 and is actively searching for eligible patients; 40 participants across two sites are expected to be recruited in total."
Is recruitment for this clinical trial still open?
"Affirmative. Clinicaltrials.gov corroborates that this medical research is currently enrolling participants, having been initially published on February 9th 2021 and recently updated on July 15th 2021. 40 patients from 2 different sites are needed for the trial to move forward."
What goals are researchers aiming to achieve with this clinical investigation?
"Over a period of one week, beginning on the day of discharge following device placement, this trial intends to measure how effectively the Spring Implant can mitigate symptoms associated with Benign Prostatic Hyperplasia (BPH) by utilizing an International Prostate Symptom Score. In addition to evaluating efficacy, secondary outcomes such as pain levels evaluated through a Visual Analog Scale (VAS), and changes in sexual health measured via Sexual Health Inventory for Men (SHIM) questionnaire score will be observed. Lastly, any Clavien-Dindo events that result in persistent disability up until three months post treatment will also be monitored."
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