- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07660068
HoLEP Sexual Survivorship
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Illinois
-
Chicago, Illinois, Stany Zjednoczone, 60611
- Northwestern University
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- 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).
Exclusion Criteria:
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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.
|
A one-time 30-45-minute telephone interview and discussion regarding the participants' after HoLEP experience and sexual satisfaction following HoLEP.
|
|
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.
|
Participants will complete questionnaires at 1, 3, 6, 12, and 24 months post-operatively
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Ejaculatory function
Ramy czasowe: 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. |
1 year
|
|
Ejaculatory bother
Ramy czasowe: 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. |
1 year
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Erectile function
Ramy czasowe: 2 years
|
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. |
2 years
|
|
Sexual function
Ramy czasowe: 2 years
|
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. |
2 years
|
|
Sexual function and sexual satisfaction
Ramy czasowe: 2 years
|
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). |
2 years
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Manifestacje urologiczne
- Stany patologiczne, oznaki i objawy
- Zachowanie
- Objawy i symptomy
- Zachowania seksualne
- Objawy dolnych dróg moczowych
- Orgazm
- Jakość opieki zdrowotnej, dostęp i ocena
- Techniki śledcze
- Metody epidemiologiczne
- Zbieranie danych
- Mechanizmy oceny opieki zdrowotnej
- Jakość opieki zdrowotnej
- Zdrowie publiczne
- Środowisko i zdrowie publiczne
- Wywiady jako temat
Inne numery identyfikacyjne badania
- STU00226001
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .