Platelet-Rich Plasma With or Without Tadalafil for Erectile Dysfunction
2026년 5월 16일 업데이트: Mahmoud Mahmoud Ahmed M. Ghanim, Benha University
Efficacy of Intracavernosal Injection of Platelet-Rich Plasma Alone Versus Combined With Oral Tadalafil in The Management of Erectile Dysfunction; A Prospective Randomized Study
Platelet-rich plasma is being studied as a regenerative treatment option for erectile dysfunction, but it is unclear whether adding daily tadalafil gives additional benefit over platelet-rich plasma alone. This study evaluates adult men with mild to mild-moderate erectile dysfunction who had an inadequate response to previous phosphodiesterase type 5 inhibitor treatment.
Participants were randomly assigned to receive either intracavernosal platelet-rich plasma injections combined with oral tadalafil 5 milligrams once daily, or intracavernosal platelet-rich plasma injections alone. The platelet-rich plasma injection protocol consisted of three intracavernosal treatment sessions spaced two weeks apart. Erectile function was assessed using the International Index of Erectile Function-5 questionnaire at baseline and during follow-up at 1, 3, and 6 months. Penile duplex Doppler ultrasound was performed at baseline and after 6 months to assess erectile blood-flow parameters.
The study hypothesis is that adding daily tadalafil to intracavernosal platelet-rich plasma may produce greater improvement in patient-reported erectile function compared with platelet-rich plasma alone, while also allowing assessment of whether this improvement is accompanied by measurable changes in penile Doppler parameters. The study included 156 participants in the final analysis, with 78 participants in each treatment group.
연구 개요
연구 유형
중재적
등록 (실제)
160
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Qalyubia Governorate
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Banhā, Qalyubia Governorate, 이집트, 13511
- Benha University Hospital
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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:
- Adult men aged 18 years or older.
- Diagnosis of mild to mild-moderate erectile dysfunction according to the International Index of Erectile Function-5.
- Inadequate response to previous phosphodiesterase type 5 inhibitor treatment.
- Eligible for intracavernosal platelet-rich plasma injection.
- Eligible for oral tadalafil treatment.
- Baseline penile duplex Doppler ultrasound assessment available.
Exclusion Criteria:
- Severe erectile dysfunction.
- Peyronie's disease.
- Previous major pelvic surgery.
- Previous pelvic trauma.
- Known bleeding or coagulation disorder.
- Contraindication to phosphodiesterase type 5 inhibitors, including nitrate therapy.
- Significant cardiac disease contraindicating tadalafil use.
- Total testosterone less than 300 nanograms per deciliter.
- Refusal or inability to provide written 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: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Platelet-Rich Plasma Plus Tadalafil
Participants received intracavernosal platelet-rich plasma injections combined with oral tadalafil.
Tadalafil was given as 5 milligrams tablet by mouth once daily.
Platelet-rich plasma was prepared from autologous whole blood using a two-step centrifugation method, activated with calcium chloride, and injected intracavernosally using a fine-gauge needle after topical local anesthesia.
The injection protocol consisted of three treatment sessions spaced two weeks apart.
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Tadalafil was administered orally as a 5 milligram tablet once daily in combination with intracavernosal platelet-rich plasma injections.
It was used as adjunct pharmacologic therapy to support erectile function during the study follow-up period.
Autologous platelet-rich plasma was prepared from whole blood using a two-step centrifugation technique and activated with calcium chloride before administration.
It was injected intracavernosally using a fine-gauge needle after topical local anesthesia.
The treatment protocol included three intracavernosal injection sessions spaced two weeks apart.
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활성 비교기: Platelet-Rich Plasma Alone
Participants received intracavernosal platelet-rich plasma injections alone without adjunct oral tadalafil.
Platelet-rich plasma was prepared from autologous whole blood using a two-step centrifugation method, activated with calcium chloride, and injected intracavernosally using a fine-gauge needle after topical local anesthesia.
The injection protocol consisted of three treatment sessions spaced two weeks apart.
|
Autologous platelet-rich plasma was prepared from whole blood using a two-step centrifugation technique and activated with calcium chloride before administration.
It was injected intracavernosally using a fine-gauge needle after topical local anesthesia.
The treatment protocol included three intracavernosal injection sessions spaced two weeks apart.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in International Index of Erectile Function-5 Score
기간: Baseline, 1 month, 3 months, and 6 months after treatment initiation
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Erectile function was 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.
Scores were compared over time between the platelet-rich plasma plus tadalafil group and the platelet-rich plasma alone group.
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Baseline, 1 month, 3 months, and 6 months after treatment initiation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Penile Peak Systolic Velocity
기간: Baseline and 6 months after treatment initiation
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Peak systolic velocity was measured by penile duplex Doppler ultrasound after pharmacologic stimulation.
It was used to assess arterial penile blood flow.
Higher values indicate better arterial inflow.
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Baseline and 6 months after treatment initiation
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Change in Penile End-Diastolic Velocity
기간: Baseline and 6 months after treatment initiation
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End-diastolic velocity was measured by penile duplex Doppler ultrasound after pharmacologic stimulation.
It was used to assess venous outflow status during erection.
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Baseline and 6 months after treatment initiation
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Change in Penile Resistive Index
기간: Baseline and 6 months after treatment initiation
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Resistive index was calculated from penile duplex Doppler ultrasound parameters after pharmacologic stimulation.
It was used as an additional measure of penile vascular resistance and erectile hemodynamics.
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Baseline and 6 months after treatment initiation
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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 4월 15일
기본 완료 (실제)
2025년 12월 15일
연구 완료 (실제)
2025년 12월 16일
연구 등록 날짜
최초 제출
2026년 5월 16일
QC 기준을 충족하는 최초 제출
2026년 5월 16일
처음 게시됨 (실제)
2026년 5월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 16일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- MD 5-10-2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Deidentified individual participant data supporting the main study results may be shared upon reasonable request.
Shared data may include baseline demographic and clinical characteristics, treatment allocation, International Index of Erectile Function-5 scores, and penile duplex Doppler ultrasound parameters.
No directly identifying participant information will be shared.
IPD 공유 기간
Data will be available beginning 6 months after publication of the main study results and will remain available for 3 years.
IPD 공유 액세스 기준
Data will be shared with qualified researchers who submit a scientifically sound research proposal.
Requests will be reviewed by the study investigators.
Data will be provided only after approval of the request and, when required, completion of a data sharing agreement.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
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. .