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Ejaculation-Preserving Versus Standard Bipolar TUEP for BPH (EP-BTUEP)

2026년 6월 1일 업데이트: Hany Fathy Badawy, MD, Beni-Suef University

Bipolar Transurethral Enucleation of the Prostate With Preservation of Ejaculation in Patients With Benign Prostatic Hyperplasia: A Randomized Controlled Trial

This prospective randomized controlled trial will compare ejaculation-preserving bipolar transurethral enucleation of the prostate with standard bipolar transurethral enucleation of the prostate in sexually active men with benign prostatic hyperplasia and lower urinary tract symptoms after failed medical treatment. Participants will be randomly assigned to either ejaculation-preserving B-TUEP or standard B-TUEP. The study will evaluate preservation of ejaculatory function, erectile function, urinary symptom improvement, uroflowmetry outcomes, post-void residual urine, perioperative complications, and need for retreatment during follow-up.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Benign prostatic hyperplasia is a common cause of lower urinary tract symptoms in aging men. Surgical treatment is indicated when medical therapy fails or when symptoms remain bothersome. Bipolar transurethral enucleation of the prostate is an established endoscopic surgical technique for benign prostatic obstruction, but standard endoscopic prostate surgery may be associated with loss of antegrade ejaculation.

This study will evaluate whether an ejaculation-preserving modification of bipolar transurethral enucleation of the prostate can preserve ejaculatory function while maintaining effective relief of lower urinary tract symptoms. The ejaculation-preserving technique will preserve the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum. The control group will undergo standard bipolar transurethral enucleation of the prostate.

Eligible sexually active men with benign prostatic hyperplasia and lower urinary tract symptoms after failed medical treatment will be randomized in a 1:1 ratio to ejaculation-preserving B-TUEP or standard B-TUEP. Sexual and urinary outcomes will be assessed using validated questionnaires and objective urinary parameters. Follow-up assessments will include ejaculatory function, erectile function, International Prostate Symptom Score, post-void residual urine, uroflowmetry, perioperative complications, and need for retreatment.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 이집트
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, 이집트
        • 모병
        • Department of Urology- Beni-Suef University Hospitals

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Male patients with lower urinary tract symptoms secondary to benign prostatic obstruction after failed medical treatment for at least 3 months.
  • Sexually active patients with a continuous relationship with the same partner.
  • International Prostate Symptom Score of 8 or greater.
  • Transrectal ultrasound-estimated prostate size between 40 and 100 cc.
  • Eligible for bipolar transurethral enucleation of the prostate.
  • Ability to complete the required sexual and urinary function questionnaires.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Preoperative sexual dysfunction.
  • Preoperative ejaculatory dysfunction.
  • Diagnosis or suspicion of prostate cancer.
  • Neurological disorders affecting lower urinary tract or sexual function.
  • Detrusor hypocontractility.
  • Catheter-dependent patients.
  • Patients with bladder stones.
  • Inability or refusal to provide informed consent.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Ejaculation-Preserving B-TUEP
Participants assigned to this arm will undergo ejaculation-preserving bipolar transurethral enucleation of the prostate. The technique will preserve the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum.
절차: Ejaculation-Preserving Bipolar Transurethral Enucleation of the Prostate
Ejaculation-preserving bipolar transurethral enucleation of the prostate will be performed with preservation of the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum.
활성 비교기: Standard B-TUEP
Participants assigned to this arm will undergo standard bipolar transurethral enucleation of the prostate without the ejaculation-preserving modifications used in the experimental arm.
절차: Standard Bipolar Transurethral Enucleation of the Prostate
Standard bipolar transurethral enucleation of the prostate will be performed according to the conventional surgical technique without preservation of the paracollicular tissue and the area approximately 1 cm proximal to the verumontanum.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Function Score From Baseline to 6 Months
기간: Baseline and 6 months postoperatively
Ejaculatory function will be assessed using the Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form function score. The function score is based on three ejaculatory function items assessing ejaculation frequency, ejaculation force, and ejaculation volume. The total function score ranges from 1 to 15, with higher scores indicating better ejaculatory function. The outcome will be calculated as the 6-month postoperative score minus the baseline score. A smaller decrease or a positive change indicates better preservation of ejaculatory function.
Baseline and 6 months postoperatively

2차 결과 측정

결과 측정
측정값 설명
기간
Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Bother Score at 6 Months
기간: 6 months postoperatively
Ejaculatory bother will be assessed using the bother item of the Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form. The bother score ranges from 0 to 5, with higher scores indicating greater bother related to ejaculatory dysfunction.
6 months postoperatively
Preservation of Antegrade Ejaculation at 6 Months
기간: 6 months postoperatively
The proportion of participants with preserved antegrade ejaculation at 6 months after surgery will be compared between the ejaculation-preserving B-TUEP group and the standard B-TUEP group. Preserved antegrade ejaculation will be defined as patient-reported antegrade seminal emission during orgasm after resumption of sexual activity. Participants reporting absent ejaculation, dry ejaculation, or retrograde ejaculation will be considered not to have preserved antegrade ejaculation.
6 months postoperatively
Change in International Index of Erectile Function-5 Score From Baseline to 6 Months
기간: Baseline and 6 months postoperatively
Erectile function will be assessed using the International Index of Erectile Function-5 questionnaire. The total score ranges from 5 to 25, with higher scores indicating better erectile function. The outcome will be calculated as the 6-month postoperative score minus the baseline score.
Baseline and 6 months postoperatively
Change in International Prostate Symptom Score From Baseline to 6 Months
기간: Baseline and 6 months postoperatively
Lower urinary tract symptoms will be assessed using the International Prostate Symptom Score. The total score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms. The outcome will be calculated as the 6-month postoperative score minus the baseline score.
Baseline and 6 months postoperatively
Change in Maximum Urinary Flow Rate From Baseline to 6 Months
기간: Baseline and 6 months postoperatively
Maximum urinary flow rate will be measured by uroflowmetry and reported in milliliters per second. The outcome will be calculated as the 6-month postoperative maximum urinary flow rate minus the baseline maximum urinary flow rate.
Baseline and 6 months postoperatively

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Beni-Suef University

수사관

  • 수석 연구원: Hany F Badawy, MD, Faculty of medicine Beni-Suef University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 9월 8일

기본 완료 (추정된)

2026년 8월 1일

연구 완료 (추정된)

2026년 9월 1일

연구 등록 날짜

최초 제출

2026년 6월 1일

QC 기준을 충족하는 최초 제출

2026년 6월 1일

처음 게시됨 (실제)

2026년 6월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 1일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • FMBSUREC07092025EjBTUEP

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared because the study includes individual-level clinical, operative, urinary, and sexual function data from participants undergoing surgery for benign prostatic hyperplasia. Only aggregated, de-identified study results will be reported in publications or presentations. Any future data sharing request will require approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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