Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH.
Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The purpose of this post-market clinical trial (PMCT) is to compare the Zenflow Spring System with Tamsulosin in men with moderate to severe BPH symptoms who are not currently receiving treatment.
The study will look at how well each treatment works, how long the results last, how quickly patients return to normal activities, how satisfied they are with their treatment, and any side effects. Patients will be followed at 1, 3, 6, and 12 months. The study will also track any implant removals or additional procedures, as well as any changes to or stopping of Tamsulosin.
Patients who qualify for the study will be randomly assigned, with an equal chance, to receive either the Zenflow Spring System or Tamsulosin.
Patients randomized to the Tamsulosin therapy arm will be allowed to crossover to receive treatment with the Zenflow Spring System after 1) their 3-month follow-up assessments are completed, 2) the patient's symptoms are confirmed to continue to warrant treatment; and 3) the patient continues to meet the study enrollment criteria. No crossover will be permitted beyond 30 days after completion of the 12-month follow-up. Patients who elect crossover and have a successful placement of the Spring Implant will be followed for 1 additional month and then will exit the study.
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
The Spring® Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25mm and 45mm and prostate sizes between 25cc and 80cc.
In addition to the above labeling requirements, patients must also meet all the following criteria to be eligible for enrollment in this study:
- Moderate to severe LUTS, defined as an International Prostate Symptom Score (IPSS ≥ 8)
Not actively taking any medication indicated for BPH, defined as current use of:
- Alpha-adrenergic antagonists (Alpha Blockers) within 2 weeks of baseline IPSS assessment
- 5-alpha reductase inhibitors (5ARI) within 6 months of baseline IPSS assessment
- PDE5 daily use (on demand use is permitted)
- Ability to provide informed consent and comply with study procedures and follow-up schedule
Exclusion Criteria:
- Known, previous adverse reaction to use of alpha-adrenergic antagonists (e.g., Tamsulosin)
Neurologic conditions affecting bladder function, including but not limited to:
- Multiple sclerosis
- Parkinson's disease
- Neurogenic bladder or other conditions causing non-obstructive voiding dysfunction
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Zenflow Arm: Zenflow Spring System Treatment
Zenflow Arm: Patients randomized to the Zenflow Spring System arm will undergo the procedure according to manufacturer specifications and standardized procedural protocols.
|
The Zenflow Spring Implant is designed to be a permanent implant but can be repositioned or removed by the physician.
|
|
Actieve vergelijker: Tamsulosin Treatment
Medical Therapy Arm: Patients randomized to the medical therapy arm will receive Tamsulosin 0.4 mg once daily.
Subjects will be encouraged to remain on this medical therapy through at least 3 months of treatment, unless significant adverse health reaction occurs.
|
Tamsulosin is a prescription medicine that relaxes the muscles around the prostate and bladder to help men with an enlarged prostate (BPH) urinate more easily
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
International Prostate Symptom Score (IPSS) Total Score
Tijdsspanne: Baseline (Day 1) to 3 months
|
Mean change in IPSS Total Score from baseline at 3 months.
This is a 7-question patient questionnaire used to measure the severity of lower urinary tract symptoms associated with BPH.
Each of the 7 symptom questions is scored from 0 to 5, giving a total possible score of 0-35.
Lower scores are better.
|
Baseline (Day 1) to 3 months
|
|
Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).
Tijdsspanne: Baseline through study completion, an average of 1 year (Duration of study)
|
Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).
|
Baseline through study completion, an average of 1 year (Duration of study)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mean change in International Prostate Symptom Score (IPSS) Total Score from baseline at 1, 6, and 12 months
Tijdsspanne: Baseline at 1, 6, and 12 months
|
Mean change in International Prostate Symptom Score (IPSS) Total Score from baseline at 1, 6, and 12 months.
This is a 7-question questionnaire used to measure the severity of lower urinary tract symptoms associated with BPH.
Each of the 7 symptom questions is scored from 0 to 5, giving a total possible score of 0-35.
Lower scores are better
|
Baseline at 1, 6, and 12 months
|
|
Mean change in International Prostate Symptom Score (IPSS) Quality of Life (QoL) from baseline 1, 3, 6 and 12 months
Tijdsspanne: Baseline 1, 3, 6 and 12 months
|
Mean change in International Prostate Symptom Score (IPSS) Quality of Life (QoL) from baseline 1, 3, 6 and 12 months.
This separate Quality of Life (QoL) question, scored 0-6, is asking how the patient would feel if they had to live with their current urinary condition for the rest of their life.
The QoL score is reported separately and is not included in the 0-35 IPSS total
|
Baseline 1, 3, 6 and 12 months
|
|
Adherence to assigned treatment (Spring Implant arm or Medical Therapy Arm) and reasons for any discontinuations
Tijdsspanne: Baseline through study completion, an average of 1 year (Study duration)
|
In the Spring Implant arm, the patient will be asked if they remain implanted with the Spring Implant and if since last visit, if patient initiated any concomitant BPH medication use (for > 2 weeks).
In the Medical Therapy Arm the patient will be asked since last visit, to confirm if they have been consistently taking Tamsulosin at the required dose.
|
Baseline through study completion, an average of 1 year (Study duration)
|
|
The observed rates of device related AEs or Tamsulosin-related adverse events
Tijdsspanne: Baseline through study completion, an average of 1 year (Duration of study)
|
The observed rates of device related AEs or Tamsulosin-related adverse events
|
Baseline through study completion, an average of 1 year (Duration of study)
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CLIN-0298
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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product vervaardigd in en geëxporteerd uit de V.S.
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