Enlarged Prostate (BPH), Enlarged Prostate With Lower Urinary Tract Symptoms
Conditions
Keywords
HoLEP
Brief summary
The objective of this study is to compare a new surgical technique for HoLEP that will allow for sparing of ejaculation post-HoLEP.
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.
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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of retrograde ejaculation | 1 year | Patient reported incidence of experiencing retrograde ejaculation |
| Ejaculatory satisfaction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual satisfaction | 1 year | 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. |
| Urinary satisfaction | 1 year | 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 |
Countries
United States
Contacts
CONTACTAlyssa McDonald, MPH
PRINCIPAL_INVESTIGATORAmy E Krambeck, MD
Northwestern University
Outcome results
None listed