Benign Prostatic HyperplasiaNCT06157164
IIT-2022-Simultaneous Urolift™ and Median Lobe Enucleation
An observational study of Benign Prostatic Hyperplasia, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
To evaluate postoperative outcomes of BPH/Lower urinary tract symptoms, erectile function, and ejaculatory capacity of simultaneous UroLiftTM and Holmium laser enucleation of the prostatic median lobe. 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 and Holmium Laser Enucleation of the Prostate (HoLEP)
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 14 Jan 2025
- 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: Males 45 years of age or older who opt for surgical management of their BPH with desire for preservation of ejaculatory function.
Who may be able to join
- Patients must be 45 years of age or older
- Patients must be diagnosed with benign prostatic hyperplasia
- Patients must opt for surgical management of their BPH with desire for preservation of ejaculatory function
- Prominent median lobe with at least grade I intravesical protrusion of median lobe visualized on pre-operative cystoscopy
Who cannot join
- Patients with baseline erectile and ejaculatory dysfunction as determined by a baseline IIEF-5 score < 15
- Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
- Patients with prostate glands greater or equal to 100 grams
- Patients with less than a grade I intravesical protrusion of median lobe on pre-operative cystoscopy
- Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Simultaneous UroLift™ and Holmium Laser Enucleation of the Prostatic Median Lobe for the Treatment of Benign Prostatic Hyperplasia in Men With Prominent Median Lobe Desiring Preservation of Ejaculation
To evaluate postoperative outcomes of BPH/Lower urinary tract symptoms, erectile function, and ejaculatory capacity of simultaneous UroLiftTM and Holmium laser enucleation of the prostatic median lobe.
Read the detailed description
Preserving ejaculation is a significant factor that impacts patient's decisions regarding what proceeding with treatment of BPH symptoms. The UroLiftTM system provides a safe procedure that has proven preservation of ejaculatory function. However, it is contraindicated in patients with prominent median lobes. The combination with laser median lobe enucleation may provide the same improvement in symptoms and widen patient inclusion criteria to those desire preserved ejaculation that also have a prominent median lobe.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- UroLift™ System and Holmium Laser Enucleation of the Prostate (HoLEP)
- Keywords
- BPH
- 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™ System and Holmium Laser Enucleation of the Prostate (HoLEP)Other
Simultaneous UroLift™ and Holmium Laser Enucleation of the Prostate (HoLEP) for the Treatment of BPH in Men with Prominent Median Lobe Desiring Preservation of Ejaculation
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous UroLift™ and HoLEP | UroLift System Receives: Other: UroLift™ System and Holmium Laser Enucleation of the Prostate (HoLEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months.
To evaluate improvement of symptoms through the International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months.
The IPSS is an 8-question screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH).
Scoring:
0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic
Measured: Up to 12 months
Secondary outcomes (5)
Post-operative participant reported outcomes using benign prostatic hyperplasia impact index (BPHII).
Evaluate post-operative participant reported outcomes using Benign Prostatic Hyperplasia Impact Index (BPHII). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority.
Measured: Up to 12 months
Post-operative participant reported outcomes using International Index of Erectile Function (IIEF).
Evaluate post-operative sexual function using participant reported outcome International Index of Erectile Function (IIEF). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority.
Measured: Up to 12 months
Post-operative participant reported outcomes using Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF).
Evaluate post-operative sexual function using participant reported outcome Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority.
Measured: Up to 12 months
Post-Operative measurement of Peak Urine Flow Rate (Qmax)
Evaluate post-operative lower urinary tract symptoms further with Peak Urine Flow Rate (Qmax). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority.
Measured: Up to 12 months
Post-Operative measurement of Post Void Residual (PVR)
Evaluate post-operative lower urinary tract symptoms further with Post Void Residual (PVR). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start6 Feb 2023
- Primary completion14 Jan 2025
- Study completion14 Jan 2025
Why it stopped: Slow accrual
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.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Neff, MD, FACS, University of Kansas Medical Center
- Investigators
- Donald Neff, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157164
- Sponsor's protocol ID
- HSC 149327
- Status last verified
- Apr 2025
- First submitted
- 28 Sep 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous UroLift™ and Holmium Laser Enucleation of the Prostatic Median Lobe for the Treatment of Benign Prostatic Hyperplasia in Men With Prominent Median Lobe Desiring Preservation of Ejaculation
- ClinicalTrials.gov ID
- NCT06157164
- Acronym / sponsor ID
- HSC 149327
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 14 Jan 2025 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 5 Dec 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.
To evaluate postoperative outcomes of BPH/Lower urinary tract symptoms, erectile function, and ejaculatory capacity of simultaneous UroLiftTM and Holmium laser enucleation of the prostatic median lobe.
Detailed description
Preserving ejaculation is a significant factor that impacts patient's decisions regarding what proceeding with treatment of BPH symptoms. The UroLiftTM system provides a safe procedure that has proven preservation of ejaculatory function. However, it is contraindicated in patients with prominent median lobes. The combination with laser median lobe enucleation may provide the same improvement in symptoms and widen patient inclusion criteria to those desire preserved ejaculation that also have a prominent median lobe.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simultaneous UroLift™ and HoLEP | – | Other: UroLift™ System and Holmium Laser Enucleation of the Prostate (HoLEP)UroLift System |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males 45 years of age or older who opt for surgical management of their BPH with desire for preservation of ejaculatory function.
Key inclusion criteria (4 listed)
- Patients must be 45 years of age or older
- Patients must be diagnosed with benign prostatic hyperplasia
- Patients must opt for surgical management of their BPH with desire for preservation of ejaculatory function
- Prominent median lobe with at least grade I intravesical protrusion of median lobe visualized on pre-operative cystoscopy
Key exclusion criteria (5 listed)
- Patients with baseline erectile and ejaculatory dysfunction as determined by a baseline IIEF-5 score < 15
- Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
- Patients with prostate glands greater or equal to 100 grams
- Patients with less than a grade I intravesical protrusion of median lobe on pre-operative cystoscopy
- Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.
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™ System and Holmium Laser Enucleation of the Prostate (HoLEP)Simultaneous UroLift™ and Holmium Laser Enucleation of the Prostate (HoLEP) for the Treatment of BPH in Men with Prominent Median Lobe Desiring Preservation of Ejaculation | Other | Simultaneous UroLift™ and HoLEP |
Primary outcome
International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months.
Time frame: Up to 12 months
To evaluate improvement of symptoms through the International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months. The IPSS is an 8-question screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Scoring: 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic
5 secondary outcomes
Post-operative participant reported outcomes using benign prostatic hyperplasia impact index (BPHII).
Time frame: Up to 12 months
Post-operative participant reported outcomes using International Index of Erectile Function (IIEF).
Time frame: Up to 12 months
Post-operative participant reported outcomes using Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF).
Time frame: Up to 12 months
Post-Operative measurement of Peak Urine Flow Rate (Qmax)
Time frame: Up to 12 months
Post-Operative measurement of Post Void Residual (PVR)
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Donald Neff principal investigator
University of Kansas Medical Center
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 University of Kansas Medical Center 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Apr 2025. 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 stopped early (reason given: Slow accrual). Results are not available in the source record.
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?
International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months. (time frame: Up to 12 months). 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 4 Apr 2025.