Holmium Laser Enucleation Of the Prostate Versus Water Vapor Therapy Of The Prostate on Sexual Function and Ejaculation
A Comparative Study of the Effect of Holmium Laser Enucleation of the Prostate Versus Water Vapor Therapy of the Prostate on Sexual Function and Ejaculation
This study aims to compare the effect of holmium laser enucleation of the prostate (HoLEP) versus water vapor therapy (Rezum) on sexual function and ejaculation in patients with benign prostatic hyperplasia (BPH).
Benign prostatic hyperplasia is a common condition affecting aging men and may lead to lower urinary tract symptoms requiring surgical intervention. While both HoLEP and Rezum are effective minimally invasive treatments, their impact on sexual function, particularly ejaculation, remains an important concern.
Participants will be assigned to undergo either HoLEP or Rezum therapy. Sexual function and ejaculatory outcomes will be evaluated using validated questionnaires before and after treatment. The study aims to determine which modality provides better preservation of sexual function while maintaining clinical efficacy.
연구 개요
상태
상세 설명
Benign prostatic hyperplasia (BPH) is a prevalent condition in aging males and is commonly associated with lower urinary tract symptoms (LUTS) that significantly affect quality of life. Surgical intervention is indicated in patients who fail medical therapy or present with complications.
Holmium laser enucleation of the prostate (HoLEP) is considered a gold standard surgical treatment for BPH, offering durable outcomes and effective removal of prostatic adenoma. However, it is frequently associated with postoperative retrograde ejaculation.
Water vapor thermal therapy (Rezum) is a minimally invasive treatment that uses convective water vapor energy to ablate prostatic tissue, with the potential advantage of preserving sexual and ejaculatory function.
This prospective comparative study aims to evaluate and compare the effects of HoLEP and Rezum on sexual function and ejaculatory outcomes. Eligible patients with BPH will be allocated to one of the two treatment groups according to the study protocol.
Primary outcomes include changes in sexual function and ejaculatory status assessed using validated questionnaires. Secondary outcomes include improvement in urinary symptoms and treatment-related complications.
The findings of this study may help guide clinical decision-making by balancing treatment efficacy with preservation of sexual function.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Banī Suwayf, 이집트, 62511
- Beni-Suef University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Male patients aged 50 years or older
- Diagnosed with benign prostatic hyperplasia (BPH)
- Presence of lower urinary tract symptoms (LUTS)
- International Prostate Symptom Score (IPSS) ≥ 13
- Peak urinary flow rate (Qmax) ≤ 15 mL/s
- Failure of medical therapy for BPH
- Sexually active and in a stable relationship
Exclusion Criteria:
- History of prostate cancer
- Prior prostate surgery
- Neurogenic bladder dysfunction
- Urethral stricture disease
- Active urinary tract infection
- Severe comorbidities contraindicating surgery
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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실험적: HoLEP Group
Patients undergoing holmium laser enucleation of the prostate for management of benign prostatic hyperplasia.
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Holmium laser enucleation of the prostate is an endoscopic surgical procedure used for the treatment of benign prostatic hyperplasia.
It involves complete enucleation of the prostatic adenoma using a holmium laser, followed by tissue morcellation.
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실험적: Rezum Group
Patients undergoing water vapor thermal therapy (Rezum) for management of benign prostatic hyperplasia.
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Water vapor thermal therapy (Rezum) is a minimally invasive procedure that uses convective radiofrequency-generated water vapor to ablate hyperplastic prostatic tissue, aiming to relieve lower urinary tract symptoms while preserving sexual function.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Sexual Function
기간: Baseline and 6 months after treatment
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Change in sexual function assessed using validated patient-reported outcome measures (e.g., International Index of Erectile Function [IIEF] comparing baseline to post-treatment values.the
IIEF score range from 5 to 25 with higher scores indicating better erectile function.
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Baseline and 6 months after treatment
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Change in ejaculatory function
기간: Baseline and 6 months after treatment
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Change in ejaculatory function assessed using validated patient-reported outcome measures (e.g., male sexual health questionnaire-Ejaculatory Dysfunction domain(MSHQ-EjD) comparing baseline to post-treatment values with higher scores indicating better ejaculatory function.
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Baseline and 6 months after treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Lower Urinary Tract Symptoms Score (IPSS)
기간: Baseline and 6 months after treatment
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Change in lower urinary tract symptoms severity assessed using the International Prostate Symptom Score (IPSS) comparing baseline to post-treatment values.
score range from 0 to 35 with higher scores indicating worse symptoms.
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Baseline and 6 months after treatment
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- FMBSUREC/03032024/Salem
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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