- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01781117
Prognostic Value of the Urinary Nerve Growth Factor in the Patients With Benign Prostatic Hyperplasia
Prognostic Value of the Urinary Nerve Growth Factor (NGF) in the Patients With Benign Prostatic Hyperplasia (BPH) Who Undergo Holmium Laser Enucleation of the Prostate (HoLEP)
Persistent detrusor overactivity (DO) after transurethral prostatectomy results in symptomatic failure in more than one third of the patients. Storage symptoms are major complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate (HoLEP). Levels of the urinary nerve growth factor (NGF), produced by bladder urothelium and smooth muscle, are increased in the patients with overactive bladder (OAB), and decreased after the OAB symptoms were improved. Also, urinary NGF levels are increased in patients with benign prostatic obstruction (BPO), but the changes of the NGF levels after relief of the BPO by the medical or surgical treatment have not been fully investigated. If the elevated urinary NGF levels are reduced after successful surgical treatment of BPO, measurement of urinary NGF could be a useful objective tool to assess the therapeutic outcomes of the operation.
The aims of this study are to measure the urinary NGF levels in patients with BPO and to compare the results between the patients with detrusor overactivity (DO) and without detrusor overactivity (Non-DO), average 2 weeks before Holmium Laser Enucleation of the Prostate (HoLEP) procedure. After HoLEP, urinary NGF levels are rechecked at the periods of postoperative 3 months and 6 months, and compare changes between the two groups.
연구 개요
상태
상세 설명
- Investigators are going to enroll age-matched control group and measure the urinary NGF levels as a baseline value (30 males).
- Investigators are going to enroll BPO patients group (DO group 50 and Non-DO group 50 patients).
- Administration of the anti-cholinergic agents was reported to decrease urinary NGF levels. Investigators are going to try to avoid the effect of anti-muscarinic drugs.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Seoul, 대한민국, 135-710
- Samsung Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male aged 50 yrs or greater
- International prostatic symptom score >= 12
- Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
- Ability and willingness to correctly complete the micturition diary and questionnaire
- Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
Exclusion Criteria:
- Patients with urologic malignancies such as prostate cancer and bladder cancer
- Patients underwent urethral, prostate surgery
- Patients with urethral stricture or bladder diverticulum or bladder neck contracture
- Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: HoLEP group
Holmium Laser Enucleation of the Prostate (HoLEP)
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Enucleation of the enlarged nodule of prostate and morcellation of the resected tissue.
Holmium laser enucleation and morcellation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Difference in the baseline urinary NGF level between patients with and without detrusor overactivity at 6 months after HoLEP procedure
기간: 6 months after HoLEP procedure
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6 months after HoLEP procedure
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Difference in the IPSS (International Prostate Symptom Score) and uroflowmetry results between the patients with or without detrusor overactivity
기간: 6 months after HoLEP procedure
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6 months after HoLEP procedure
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기타 결과 측정
결과 측정 |
기간 |
|---|---|
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Difference in the serum PSA (Prostate Specific Antigen) level between the patients with or without detrusor overactivity
기간: 6 months after HoLEP procedure
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6 months after HoLEP procedure
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Kyu-Sung Lee, M.D., Ph.D., Samsung Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2012-11-013
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