Ejaculatory-Sparing HoLEP vs Standard HoLEP

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-100
SponsorNorthwestern University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ejaculatory-sparing (ES-sparing) HoLEP

    Other intervention

    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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Standard HoLEPNo intervention 0 interventions
Group B: ES-HoLEPActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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