Pelvic Floor Therapies for Lifelong Premature Ejaculation (PE-PFMT)
Electromagnetic Pelvic Floor Stimulation Versus Biofeedback-Assisted and Conventional Pelvic Floor Muscle Training in Men With Lifelong Premature Ejaculation: A Randomized Controlled Trial
연구 개요
상태
상세 설명
Premature ejaculation is one of the most common male sexual dysfunctions and may negatively affect quality of life, sexual satisfaction, and interpersonal relationships. Pelvic floor muscles, particularly the bulbocavernosus and ischiocavernosus muscles, are involved in ejaculatory control. Pelvic floor muscle training has been used as a non-pharmacological treatment for premature ejaculation; however, its effectiveness may be limited by incorrect muscle identification and poor adherence. Biofeedback-assisted pelvic floor muscle training may improve patient awareness and neuromuscular coordination. Electromagnetic pelvic floor stimulation is a non-invasive modality designed to induce repeated pelvic floor muscle contractions and may improve pelvic floor muscle function.
After approval by the Research Ethics Committee, Faculty of Medicine, Tanta University, eligible participants will be recruited from the outpatient clinic of the Urology Department, Tanta University. Men aged 18 to 50 years with lifelong premature ejaculation and intravaginal ejaculatory latency time of less than 1 minute will be enrolled after providing written informed consent. Participants will be randomly assigned in a 1:1:1 ratio to receive electromagnetic pelvic floor stimulation, biofeedback-assisted pelvic floor muscle training, or conventional pelvic floor muscle training.
Baseline assessment will include medical and sexual history, physical examination, stopwatch-measured intravaginal ejaculatory latency time, Premature Ejaculation Diagnostic Tool score, International Index of Erectile Function-5 score, patient-reported ejaculatory control, sexual satisfaction, and partner satisfaction. Intravaginal ejaculatory latency time will be calculated as the average of at least three consecutive intercourse attempts. Outcomes will be assessed at baseline, at the end of treatment at 6 weeks, and at 3-month follow-up. Treatment adherence and adverse events will be recorded throughout the study.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hany F Badawy, MD
- 전화번호: +201149525028
- 이메일: HANYFATHY86@GMAIL.COM
연구 연락처 백업
- 이름: Mohamed I Elmaadawy, MD
- 전화번호: +201060245430
- 이메일: Mohamed.elmaadawy@med.tanta.edu.eg
연구 장소
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Tanta
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Tanta, Tanta, 이집트
- 모병
- Department of Urology- Tanra University Hospitals
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연락하다:
- Mohamed I Elmaadawy, MD
- 전화번호: +201060245430
- 이메일: Mohamed.elmaadawy@med.tanta.edu.eg
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Men aged 18 to 50 years.
- Diagnosis of lifelong premature ejaculation.
- Intravaginal ejaculatory latency time less than 1 minute.
- Ability and willingness to comply with the treatment protocol and follow-up visits.
- Written informed consent.
Exclusion Criteria:
- Erectile dysfunction.
- Neurological disease.
- Previous pelvic surgery.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Electromagnetic Pelvic Floor Stimulation
Participants allocated to this arm will receive non-invasive electromagnetic pelvic floor stimulation over a 6-week treatment period according to the institutional pelvic floor rehabilitation protocol.
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Non-invasive electromagnetic pelvic floor stimulation will be applied to induce repeated pelvic floor muscle contractions.
Treatment will be delivered over 6 weeks according to the institutional pelvic floor rehabilitation protocol.
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활성 비교기: Biofeedback-Assisted Pelvic Floor Muscle Training
Participants allocated to this arm will receive supervised pelvic floor muscle training assisted by biofeedback over a 6-week treatment period to improve pelvic floor muscle awareness, contraction, relaxation, and coordination.
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Participants will receive supervised pelvic floor muscle training assisted by biofeedback over a 6-week treatment period to improve pelvic floor muscle awareness, contraction, relaxation, and coordination.
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활성 비교기: Conventional Pelvic Floor Muscle Training
Participants allocated to this arm will receive conventional pelvic floor muscle training over a 6-week treatment period according to the institutional pelvic floor rehabilitation protocol.
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Participants will receive conventional pelvic floor muscle training aimed at improving pelvic floor muscle control and ejaculatory control.
Treatment will be delivered over 6 weeks according to the institutional physiotherapy protocol.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Intravaginal Ejaculatory Latency Time at 6 Weeks
기간: Baseline and 6 weeks
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Intravaginal ejaculatory latency time will be measured using a stopwatch.
The average of at least three consecutive intercourse attempts will be recorded.
The outcome will be expressed as the change in intravaginal ejaculatory latency time from baseline to the end of treatment at 6 weeks.
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Baseline and 6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Intravaginal Ejaculatory Latency Time at 3 Months
기간: Baseline and 3 months
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Intravaginal ejaculatory latency time will be measured using a stopwatch.
The average of at least three consecutive intercourse attempts will be recorded.
The outcome will be expressed as the change from baseline to 3-month follow-up.
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Baseline and 3 months
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Change in Premature Ejaculation Diagnostic Tool Score at 6 Weeks
기간: Baseline and 6 weeks
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The Premature Ejaculation Diagnostic Tool will be used to assess the severity of premature ejaculation.
The outcome will be expressed as the change in total score from baseline to 6 weeks.
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Baseline and 6 weeks
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Change in Patient-Reported Ejaculatory Control at 6 Weeks
기간: Baseline and 6 weeks
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Patient-reported ejaculatory control will be assessed using a Likert scale.
The outcome will be expressed as the change from baseline to 6 weeks.
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Baseline and 6 weeks
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Mohamed I Elmaadawy, MD, Tanta 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
기타 연구 ID 번호
- PEPFMT36265PR25426
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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