Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg
Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg for Ureteric Stent Related Symptoms
Ureteral stenting is a common urological procedure performed to relieve obstruction and facilitate urinary drainage. Despite its effectiveness, stent-related symptoms (SRS) such as dysuria, frequency, urgency, flank pain, and sexual discomfort negatively affect patient quality of life.
Pharmacological management with alpha-blockers such as Tamsulosin and phosphodiesterase-5 inhibitors (PDE5i) such as Tadalafil has shown promise in reducing SRS. While low-dose Tadalafil (2.5 mg) has not been explored, its comparative effectiveness against the standard 5 mg dose when combined with Tamsulosin remains under-researched. This study aims to evaluate the difference in reduction of SRS between Tamsulosin with Tadalafil in standard and half dosage.
연구 개요
상세 설명
Ureteral stents are commonly used for temporary drainage in various urological procedures. Despite their usefulness, they are frequently associated with bothersome symptoms collectively termed as "stent-related symptoms" (SRS),These symptoms include flank pain, lower urinary tract symptoms (LUTS), hematuria, dysuria, urgency, frequency, and sexual dysfunction.
The exact pathophysiology of SRS is multifactorial, involving local irritation, vesicoureteral reflux, and smooth muscle spasm.
Various pharmacological agents have been studied to alleviate these symptoms, with alpha-blockers and PDE-5 inhibitors showing promising results .
Tamsulosin, a selective al-blocker, reduces bladder neck and distal ureteral smooth muscle tone, alleviating irritative urinary symptoms.
Tadalafil, a PDE-5 inhibitor, has been shown to improve LUTS through its smooth muscle relaxation and increased perfusion effects. While both have been studied individually and in combination, the optimal dose of Tadalafil in combination therapy is yet to be clearly established
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ahmed Amr Mohammed Mounier, MSc
- 전화번호: +201111984645
- 이메일: 160022@med.asu.edu.eg
연구 연락처 백업
- 이름: Waleed Mousa, Professor
- 전화번호: +201067628771
- 이메일: Waleedmousa@med.asu.edu.eg
연구 장소
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Abbasia
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Cairo, Abbasia, 이집트
- 모병
- Ain Shams University Hospital
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연락하다:
- Hisham Arafa, Lecturer
- 전화번호: +201001921334
- 이메일: Hishamarafa1988@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- patients older than 18 years of age, with presence of a double-J (DJ) stent (polyurethane) post endoscopic stone removal.
Exclusion Criteria:
- Patients younger than 18 years of age were excluded.
- Patients with a history of prostate or bladder surgery were excluded.
- Patients with prior lower urinary tract procedures were excluded.
- Patients with cancer were excluded.
- Patients with neurological conditions were excluded.
- Patients with a history of pelvic radiation were excluded.
- Patients with diabetes were excluded.
- Patients with kidney dysfunction (acute or chronic) were excluded.
- Patients with a solitary kidney were excluded.
- Patients with congenital urinary anomalies were excluded.
Patients taking the following medications were excluded:
- α-blockers
- beta-blockers
- calcium channel blockers
- 5-alpha reductase inhibitors
- PDE5 inhibitors
- anticholinergics
- nitrates
- Patients with cardiac issues were excluded.
- Patients with residual stone fragments after surgery were excluded.
- Patients with multiple or bilateral ureteral stones were excluded.
- Patients with long-term or bilateral stents requiring frequent changes were excluded.
- Patients with interstitial cystitis were excluded.
- Patients with chronic cystitis were excluded.
- Patients with prostatitis were excluded.
- Pregnant women were excluded.
- Breastfeeding women were excluded.
- Patients unavailable for follow-up were excluded.
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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활성 비교기: Group A : (Tamsulosin 0.4 mg + Tadalafil 2.5 mg)
About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 2.5 mg tablets daily for evaluation of relieving stent-related symptoms
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Evaluation of safety and efficacy of Tamsulosin 0.4 mg plus Tadalafil 2.5 mg versus Tamsulosin 0.4 mg plus Tadalafil 5 mg in relieving stent-related symptoms.
다른 이름들:
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활성 비교기: Group B:(Tamsulosin 0.4 mg + Tadalafil 5 mg)
About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 5 mg tablets daily for evaluation of relieving stent-related symptoms
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Evaluation of safety and efficacy of Tamsulosin 0.4 mg plus Tadalafil 2.5 mg versus Tamsulosin 0.4 mg plus Tadalafil 5 mg in relieving stent-related symptoms.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Evaluation of Ureteral Stent Symptoms
기간: 4 weeks
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Evaluation of Ureteral Stent Symptoms postoperatively using Questionnaire (USSQ) score after treatment (from 1 to 5) as: 1 is best relief of symptoms but 5 is worsen relief of symptoms
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4 weeks
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공동 작업자 및 조사자
수사관
- 연구 책임자: Waleed Mousa, Professor, Assistant Professor of Urology Department of Urology Ain Shams 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
추가 관련 MeSH 약관
- 비뇨생식기 질환
- 남성 비뇨 생식기 질환
- 미적분학
- 병리학적 상태, 해부학적
- 신장 질환
- 비뇨기과 질환
- 여성 비뇨 생식기 질환
- 여성 비뇨 생식기 질환 및 임신 합병증
- 요로결석증
- 요로 결석
- 요관 질환
- 신장결석증
- 병리학적 상태, 징후 및 증상
- 신장 결석
- 요관결석증
- 황 화합물
- 유기 화학 물질
- 피리딘
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 이종 사이 클릭 화합물, 2- 링
- 이종 사이 클릭 화합물, 융합 링
- 탄화수소
- 탄화수소, 순환
- 탄화수소, 방향족
- 아미드
- 인돌
- 벤젠 유도체
- 인돌 알칼로이드
- 벤젠 설포 아미드
- 설폰 아미드
- 설폰
- 이종 사이 클릭 화합물, 3- 링
- 카르 볼린
- 타다라필
- 탐술로신
기타 연구 ID 번호
- Ureteric Stent
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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