Ejaculatory-Sparing HoLEP vs Standard HoLEP
Ejaculatory-sparing Holmium Laser Enucleation of the Prostate (HoLEP) vs Standard HoLEP: a Randomized Controlled Trial
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Alyssa McDonald, MPH
- 전화번호: 312-695-8146
- 이메일: alyssa.mcdonald@northwestern.edu
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60611
- 모병
- Northwestern University
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수석 연구원:
- Amy E Krambeck, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Standard HoLEP
HoLEP procedure performed using standard care technique.
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활성 비교기: ES-HoLEP
HoLEP procedure performed using ejaculatory-sparing HoLEP technique.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of retrograde ejaculation
기간: 1 year
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Patient reported incidence of experiencing retrograde ejaculation
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1 year
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Ejaculatory satisfaction
기간: 1 year
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sexual satisfaction
기간: 1 year
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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. |
1 year
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Urinary satisfaction
기간: 1 year
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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 |
1 year
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Urinary satisfaction
기간: 1 year
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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. |
1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Amy E Krambeck, MD, Northwestern University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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