BPHNCT07660068
HoLEP Sexual Survivorship
An observational study of BPH and Lower Urinary Tract Symptoms, run by Northwestern University at 1 site in United States.
Trial summary
The objective of this study is to evaluate how sexual function, ejaculatory function, and overall sexual satisfaction change following Holmium Laser Enucleation of the Prostate (HoLEP). In doing so, the study team will examine the trade-off between relief of lower urinary tract symptoms and changes in sexual function. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- BPH, Lower Urinary Tract Symptoms
- What is being tested?
- Telephone Interview and Questionnaires over the span of 24 months
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2026to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Males 18-100 years old with decision making capability electing to pursue HoLEP for the treatment of bothersome lower urinary tract symptoms.
Who may be able to join
- Males 18-100 years old
- Electing to undergo HoLEP for the treatment of bothersome lower urinary tract symptoms
- Currently have present antegrade ejaculation (the standard, male ejaculatory process where semen is propelled forward and out through the urethra during orgasm).
Who cannot join
- Patients with any of the following:
- Indwelling urinary catheter prior to surgery
- Neurological disease
- History of prior prostatic/urethral surgery that may impact ejaculation
- Patients who lack decisional capacity
- Patients unable to read, understand, and speak English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Patient Perspectives on the Trade-off Between Voiding Improvement and Sexual Dysfunction Following HoLEP
The objective of this study is to evaluate how sexual function, ejaculatory function, and overall sexual satisfaction change following Holmium Laser Enucleation of the Prostate (HoLEP).
In doing so, the study team will examine the trade-off between relief of lower urinary tract symptoms and changes in sexual function.
Read the detailed description
The objective of this study is to evaluate how sexual function, ejaculatory function, and overall sexual satisfaction change following Holmium Laser Enucleation of the Prostate (HoLEP).
Retrograde ejaculation is a common and expected consequence of the procedure and meaningfully influences surgical decision-making. Through the study team's findings, the study team aims to characterize the longitudinal impact of HoLEP and if it induces patient regret.
In doing so, the study team will examine the trade-off between relief of lower urinary tract symptoms and changes in sexual function. This study seeks to generate patient-centered data to inform shared decision-making for men considering HoLEP.
- Conditions
- BPH, Lower Urinary Tract Symptoms
- Being tested
- Telephone Interview, Questionnaires over the span of 24 months
- Keywords
- Sexual satisfaction, Men's sexual health
- Medical subject headings
- Lower Urinary Tract Symptoms, Orgasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone InterviewOther
A one-time 30-45-minute telephone interview and discussion regarding the participants' after HoLEP experience and sexual satisfaction following HoLEP.
Questionnaires over the span of 24 monthsOther
Participants will complete questionnaires at 1, 3, 6, 12, and 24 months post-operatively
| Study group | Role | What they receive |
|---|---|---|
| Focus Group | To better assess what questions are pertinent to patient sexual satisfaction post-HoLEP, the study team will first conduct a preliminary study of 15 patients who are currently sexually active after the HoLEP procedure. The preliminary study will be conducted by a one-time 30-45-minute telephone interview and discussion regarding the participants' after HoLEP experience and sexual satisfaction following HoLEP. Receives: Other: Telephone Interview | |
| Longitudinal Cohort | The main longitudinal study in which the study team will follow HoLEP patients for 24 months post-operatively. The longtiudinal study cohort is powered to detect a clinically meaningful discrepancy in symptoms after the HoLEP procedure and patient reported ratings. Receives: Other: Questionnaires over the span of 24 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ejaculatory function
Patient reported satisfaction of ejaculation using Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD) questionnaire. The MSHQ-EjD-SF evaluates the following parameters in regards to ejaculation: Frequency, Force, Volume and Bother (How much are you bothered by any ejaculation difficulties) on a 6-point Likert scale (typically scored 0 to 5).
Interpretation: Higher scores indicate better ejaculatory function, while lower scores denote dysfunction and a greater level of personal distress regarding one's ejaculatory function.
Measured: 1 year
Ejaculatory bother
Patient reported bothersome of ejaculation quality using Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD) questionnaire. The MSHQ-EjD-SF evaluates the following parameters in regards to ejaculation: Frequency, Force, Volume and Bother (How much are you bothered by any ejaculation difficulties) on a 6-point Likert scale (typically scored 0 to 5).
Interpretation: Higher scores indicate better ejaculatory function, while lower scores denote dysfunction and a greater level of personal distress regarding one's ejaculatory function.
Measured: 1 year
Secondary outcomes (3)
Erectile function
Patient reported satisfaction of sexual function and overall sexual satisfaction using the International Index of Erectile Function-5 (IIEF-5).
The IIEF (International Index of Erectile Function) is a 15-question, self-administered survey used globally as a clinical "gold standard" to diagnose the presence and severity of erectile dysfunction (ED) and track sexual health outcomes.
Interpretation: The IIEF-5 exclusively assesses erectile and intercourse satisfaction, with scores ranging from 5 to 25. Higher scores generally indicate mild to no erectile dysfunction. Lower scores represent declining erectile function.
Measured: 2 years
Sexual function
Patient reported satisfaction of sexual function and overall sexual satisfaction using the SFI (Brief Sexual Function Inventory).
The SFI is an 11-item, administered questionnaire used to evaluate male sexual function and how it is impacted by conditions like Lower Urinary Tract Symptoms (LUTS).
Interpretation: Each of the 11 items is rated on a Likert scale (typically 0 to 4 points). The total score is the sum of the responses, with higher scores generally indicating better sexual function and lower scores highlighting more severe impairment or dysfunction.
Measured: 2 years
Sexual function and sexual satisfaction
Patient reported satisfaction of sexual function and overall sexual satisfaction using the MSF-4 (Male Sexual Function-4).
The MSF-4 (Male Sexual Function-4) is a four-question survey designed to evaluate male sexual health in clinical urology settings. It is primarily used to track changes in sexual function for men dealing with Lower Urinary Tract Symptoms (LUTS) or Benign Prostatic Hyperplasia (BPH).
Interpretation: Each of the 4 items uses a Likert-type scale (typically ranging from 1 to 4 or 1 to 5). Higher scores generally indicate better sexual functioning and higher satisfaction. Lower scores represent worsening sexual function or increased sexual dysfunction (such as erectile or ejaculatory issues).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start26 May 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Krambeck, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660068
- Sponsor's protocol ID
- STU00226001
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perspectives on the Trade-off Between Voiding Improvement and Sexual Dysfunction Following HoLEP
- ClinicalTrials.gov ID
- NCT07660068
- Acronym / sponsor ID
- STU00226001
- Conditions
- BPH, Lower Urinary Tract Symptoms
- Keywords
- Sexual satisfaction, Men's sexual health
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 26 May 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 22 Jun 2026 (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 this study is to evaluate how sexual function, ejaculatory function, and overall sexual satisfaction change following Holmium Laser Enucleation of the Prostate (HoLEP).
In doing so, the study team will examine the trade-off between relief of lower urinary tract symptoms and changes in sexual function.
Detailed description
The objective of this study is to evaluate how sexual function, ejaculatory function, and overall sexual satisfaction change following Holmium Laser Enucleation of the Prostate (HoLEP).
Retrograde ejaculation is a common and expected consequence of the procedure and meaningfully influences surgical decision-making. Through the study team's findings, the study team aims to characterize the longitudinal impact of HoLEP and if it induces patient regret.
In doing so, the study team will examine the trade-off between relief of lower urinary tract symptoms and changes in sexual function. This study seeks to generate patient-centered data to inform shared decision-making for men considering HoLEP.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focus Group | – | Other: Telephone InterviewTo better assess what questions are pertinent to patient sexual satisfaction post-HoLEP, the study team will first conduct a preliminary study of 15 patients who are currently sexually active after the HoLEP procedure. The preliminary study will be conducted by a one-time 30-45-minute telephone interview and discussion regarding the participants' after HoLEP experience and sexual satisfaction following HoLEP. |
| Longitudinal Cohort | – | Other: Questionnaires over the span of 24 monthsThe main longitudinal study in which the study team will follow HoLEP patients for 24 months post-operatively. The longtiudinal study cohort is powered to detect a clinically meaningful discrepancy in symptoms after the HoLEP procedure and patient reported ratings. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males 18-100 years old with decision making capability electing to pursue HoLEP for the treatment of bothersome lower urinary tract symptoms.
Key inclusion criteria (3 listed)
- Males 18-100 years old
- Electing to undergo HoLEP for the treatment of bothersome lower urinary tract symptoms
- Currently have present antegrade ejaculation (the standard, male ejaculatory process where semen is propelled forward and out through the urethra during orgasm).
Key exclusion criteria (6 listed)
- Patients with any of the following:
- Patients who lack decisional capacity
- Patients unable to read, understand, and speak English
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 |
|---|---|---|
| Telephone InterviewA one-time 30-45-minute telephone interview and discussion regarding the participants' after HoLEP experience and sexual satisfaction following HoLEP. | Other | Focus Group |
| Questionnaires over the span of 24 monthsParticipants will complete questionnaires at 1, 3, 6, 12, and 24 months post-operatively | Other | Longitudinal Cohort |
Primary outcome
Ejaculatory function
Time frame: 1 year
Patient reported satisfaction of ejaculation using Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD) questionnaire. The MSHQ-EjD-SF evaluates the following parameters in regards to ejaculation: Frequency, Force, Volume and Bother (How much are you bothered by any ejaculation difficulties) on a 6-point Likert scale (typically scored 0 to 5). Interpretation: Higher scores indicate better ejaculatory function, while lower scores denote dysfunction and a greater level of personal distress regarding one's ejaculatory function.
Ejaculatory bother
Time frame: 1 year
Patient reported bothersome of ejaculation quality using Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD) questionnaire. The MSHQ-EjD-SF evaluates the following parameters in regards to ejaculation: Frequency, Force, Volume and Bother (How much are you bothered by any ejaculation difficulties) on a 6-point Likert scale (typically scored 0 to 5). Interpretation: Higher scores indicate better ejaculatory function, while lower scores denote dysfunction and a greater level of personal distress regarding one's ejaculatory function.
3 secondary outcomes
Erectile function
Time frame: 2 years
Sexual function
Time frame: 2 years
Sexual function and sexual satisfaction
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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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.
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 BPH and Lower Urinary Tract Symptoms, run by Northwestern University 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 3 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 15 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Ejaculatory function (time frame: 1 year). The study lists 2 primary outcomes in all. 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 15 Oct 2026.