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RecruitingNCT07631286Updated Aug 20, 2026

Ejaculatory-Sparing HoLEP vs Standard HoLEP

An interventional study of Ejaculatory-sparing (ES-sparing) HoLEP in Enlarged Prostate (BPH) and Enlarged Prostate With Lower Urinary Tract Symptoms, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to male participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Northwestern University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
Male
01

Study summary

The objective of this study is to compare a new surgical technique for HoLEP that will allow for sparing of ejaculation post-HoLEP.

Read the detailed description

The primary aim of this study is to assess the efficacy of ejaculatory-sparing HoLEP (ES-HoLEP) in preserving ejaculation while also maintaining good urinary outcomes.

02

Conditions studied

  • Enlarged Prostate (BPH)
  • Enlarged Prostate With Lower Urinary Tract Symptoms

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Keywords

  • HoLEP
03

In context

Prostatic Hyperplasia

827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.

This study's planned enrollment of 48 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.

Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- Patients who are sexually active with antegrade ejaculation who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms.

Exclusion criteria

Exclusion Criteria:

  • Patients with pre-existing retrograde ejaculation
  • Patients who are not sexually active
  • Patients with indwelling urinary catheter prior to surgery, neurological disease, or history of prior prostatic/urethral surgery that may impact ejaculation
  • Patients who lack decisional capacity
  • Patients unable to read/speak English
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • No intervention
    Standard HoLEP

    HoLEP procedure performed using standard care technique.

  • Active comparator
    ES-HoLEP

    HoLEP procedure performed using ejaculatory-sparing HoLEP technique.

    Other: Ejaculatory-sparing (ES-sparing) HoLEP

Interventions

  • OtherEjaculatory-sparing (ES-sparing) HoLEP

    The ejaculatory sparing technique involves sparing the distal apex of the prostate in particular the anterior portion of the prostate which will allow for coaptation necessary for antegrade ejaculation.

06

What researchers measure

Primary outcomes

  1. Incidence of retrograde ejaculation

    Patient reported incidence of experiencing retrograde ejaculation

    Time frame: 1 year

  2. Ejaculatory satisfaction

    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.

    Time frame: 1 year

Secondary outcomes

  1. Sexual satisfaction

    Patient reported sexual satisfaction using the Sexual Health Inventory for Men (SHIM) questionnaire. The Sexual Health Inventory for Men (SHIM) contains 5 questions that is individually scored on a scale of 0 to 5. The SHIM score is calculated by adding up the scores of the 5 individual questions. Interpretation: Higher scores indicate better erectile function, while lower scores denote erectile dysfunction. A total score of 21 or less indicates that erectile dysfunction is present and should be addressed with a healthcare provider.

    Time frame: 1 year

  2. Urinary satisfaction

    Patient reported urinary satisfaction using the International Prostate Symptom Score (IPSS) questionnaire. The International Prostate Symptom Score (IPSS) is calculated by asking patients to rate 7 urinary symptoms over the past month on a scale from 0 to 5. These scores are simply added together to yield a total symptom severity score ranging from 0 to 35. An 8th question measures overall Quality of Life (QoL) but is not factored into the numerical total. Interpretation: the total score range is from 0 to 35. The total score indicates symptom severity: 0-7: Mildly symptomatic 8-19: Moderately symptomatic 20-35: Severely symptomatic

    Time frame: 1 year

  3. Urinary satisfaction

    Patient reported urinary satisfaction using the Michigan Incontinence Symptom Index (M-ISI) questionnaires. The M-ISI (Michigan Incontinence Symptom Index) questionnaire is a 10-item clinical tool used to evaluate the severity of urinary incontinence and how much it bothers the patient. It is calculated by assigning scores (0 to 4) to each answer and summing them across two primary domains. Total M-ISI Severity Domain (Items 1-8): Sum of the scores for the first 8 questions. This evaluates incontinence subdomains (Stress Urinary Incontinence, Urgency Urinary Incontinence, and Pad Use). Possible score range 0 to 32. Bother Domain (Items 9-10): Sum of the scores for questions 9 and 10. This measures the emotional and physical impact of the leakage. Possible score range 0 to 8. Interpretation: Higher scores indicate the individual is likely incontinent or has experience with incontinence.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07631286
Responsible party
Amy Krambeck (Director of the Endourology/Stone Division, Northwestern University) — Principal investigator
First posted
Jun 8, 2026
Start date
Jun 15, 2026
Primary completion
May 2027 (estimated)
Completion
May 2028 (estimated)
Last update
Aug 20, 2026

Study contacts

Alyssa McDonald, MPH
Contact
alyssa.mcdonald@northwestern.edu
312-695-8146
Amy E Krambeck, MD
principal investigator · Northwestern University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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