Benign Prostatic HyperplasiaRELIEFNCT05784558
RELIEF Study: Real-world Evaluation of LUTS Interventions and Patient Experience During Follow-up
An observational study of Benign Prostatic Hyperplasia, run by NeoTract, Inc. at 1 site in United States.
Trial summary
The objective of the RELIEF Study is to compare the safety, effectiveness and patient experience outcomes in real-world subjects treated with different modalities for symptomatic BPH. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- UroLift System, Watchful Waiting or BPH Medications and Other Surgical Intervention
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2025to 24 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH)
Who may be able to join
- Diagnosis of symptomatic BPH
Who cannot join
- Prior surgical intervention for treatment of BPH
- Unable or unwilling to give informed consent or unwilling to complete all required questionnaires and follow-up assessments
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the RELIEF Study is to compare the safety, effectiveness and patient experience outcomes in real-world subjects treated with different modalities for symptomatic BPH.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- UroLift System, Watchful Waiting or BPH Medications, Other Surgical Intervention
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroLift SystemDevice
The UroLift System is a procedure that utilizes tiny implants to lift and hold the enlarged prostate tissue out of the way so it no longer blocks the urethra.
Watchful Waiting or BPH MedicationsOther
Subjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing BPH medications.
Other Surgical InterventionDevice
Physician decides the best course of therapy to be a surgical intervention other than the UroLift System.
| Study group | Role | What they receive |
|---|---|---|
| UroLift System | Therapy to be treatment with the UroLift System. Receives: Device: UroLift System | |
| Watchful Waiting or BPH Medications | Subjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing BPH medications. Receives: Other: Watchful Waiting or BPH Medications | |
| Other Surgical Intervention | Physician decides the best course of therapy to be a surgical intervention other than the UroLift System. Receives: Device: Other Surgical Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify responders of IPSS change
Change of >3 points in IPSS score from baseline to the 3 months post-treatment visit.
Measured: 3 months post-treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start26 Jan 2025 (estimated)
- Primary completion26 Jan 2026 (estimated)
- Study completion24 Sep 2026 (estimated)
Why it stopped: Sponsor decided to cancel the study due to the study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoTract, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784558
- Sponsor's protocol ID
- CP00022
- Other IDs
- CP00022
- Acronym
- RELIEF
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2023
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELIEF Study: Real-world Evaluation of LUTS Interventions and Patient Experience During Follow-up
- ClinicalTrials.gov ID
- NCT05784558
- Acronym / sponsor ID
- RELIEF / CP00022
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decided to cancel the study due to the study design
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NeoTract, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2025 (estimated)
- Primary completion
- 26 Jan 2026 (estimated)
- Study completion
- 24 Sep 2026 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the RELIEF Study is to compare the safety, effectiveness and patient experience outcomes in real-world subjects treated with different modalities for symptomatic BPH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UroLift System | – | Device: UroLift SystemTherapy to be treatment with the UroLift System. |
| Watchful Waiting or BPH Medications | – | Other: Watchful Waiting or BPH MedicationsSubjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing BPH medications. |
| Other Surgical Intervention | – | Device: Other Surgical InterventionPhysician decides the best course of therapy to be a surgical intervention other than the UroLift System. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH)
Key inclusion criteria (1 listed)
- Diagnosis of symptomatic BPH
Key exclusion criteria (2 listed)
- Prior surgical intervention for treatment of BPH
- Unable or unwilling to give informed consent or unwilling to complete all required questionnaires and follow-up assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UroLift SystemThe UroLift System is a procedure that utilizes tiny implants to lift and hold the enlarged prostate tissue out of the way so it no longer blocks the urethra. | Device | UroLift System |
| Watchful Waiting or BPH MedicationsSubjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing BPH medications. | Other | Watchful Waiting or BPH Medications |
| Other Surgical InterventionPhysician decides the best course of therapy to be a surgical intervention other than the UroLift System. | Device | Other Surgical Intervention |
Primary outcome
To identify responders of IPSS change
Time frame: 3 months post-treatment visit
Change of >3 points in IPSS score from baseline to the 3 months post-treatment visit.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by NeoTract, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify responders of IPSS change (time frame: 3 months post-treatment visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.