ExMI vs. Biofeedback PFMT for Post-Prostatectomy Incontinence
2026년 7월 7일 업데이트: Abdullah Salah Al Debeiky, Tanta University
Effect of Extracorporeal Magnetic Stimulation Added to Pelvic Floor Muscle Training on Post-Prostatectomy Urine Incontinence: A Prospective Randomized Controlled Trial
This study looks at whether adding a non-invasive magnetic stimulation treatment to standard pelvic floor exercises helps men regain bladder control faster after prostate surgery (HoLEP or bipolar enucleation).
Some men experience temporary urine leakage after this type of surgery.
Participants will be randomly assigned to receive either pelvic floor muscle exercises alone, or pelvic floor muscle exercises combined with magnetic stimulation sessions using a specialized chair.
Researchers will measure how long it takes for bladder control to return, how much urine leakage occurs, and how each treatment affects participants' quality of life over 6 months of follow-up.
연구 개요
상태
모집하지 않고 적극적으로
상세 설명
This is a prospective, randomized controlled trial conducted at the outpatient urology clinic of Tanta University Hospital evaluating the effect of extracorporeal magnetic stimulation (ExMI) added to pelvic floor muscle training (PFMT) versus biofeedback-assisted PFMT alone on recovery of urinary continence following Holmium Laser Enucleation of the Prostate (HoLEP) or Bipolar Enucleation of the Prostate (BipoLEP) for benign prostatic hyperplasia.
A total of 100 male patients aged 50 years or older who develop postoperative stress-predominant urinary incontinence after catheter removal will be randomized in a 1:1 ratio to Group 1 (electromagnetic pelvic floor stimulation, n=50) or Group 2 (biofeedback-assisted pelvic floor muscle training, n=50).
All participants will receive supervised PFMT consisting of three daily sessions (10 slow contractions of 5-10 seconds and 10 rapid contractions per session) for 12 weeks postoperatively. Group 1 will additionally receive extracorporeal magnetic stimulation using a magnetic chair device, twice weekly for 20-30 minutes per session over 6-8 weeks, at an intensity adjusted to patient tolerance, aiming to induce repetitive pelvic floor muscle contraction and pudendal nerve stimulation.
Continence status will be assessed after catheter removal and at follow-up visits at 2 weeks, 1 month, 3 months, and 6 months postoperatively, using pad count, 24-hour pad weight testing, the ICIQ-UI SF questionnaire, and quality-of-life scoring. Continence will be defined as no pad use, or use of one security pad with no significant leakage.
The primary outcome is time to recovery of urinary continence. Secondary outcomes include reduction in pad usage, improvement in 24-hour pad test results, improvement in ICIQ-UI SF score, quality-of-life improvement, and treatment-related adverse events.
연구 유형
중재적
등록 (추정된)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Tanta, 이집트, 31111
- Tanta University Hospital
-
-
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 aged ≥50 years
- Diagnosed with symptomatic benign prostatic hyperplasia (BPH) requiring surgical intervention
- Scheduled for Holmium Laser Enucleation of the Prostate (HoLEP) or Bipolar Enucleation of the Prostate (BipoLEP)
- Development of postoperative stress-predominant urinary incontinence after catheter removal
- Presence of postoperative urinary leakage requiring at least one safety pad/day
- Ability to understand and perform pelvic floor muscle training instructions
- Ability and willingness to attend extracorporeal magnetic stimulation sessions and follow-up visits
Exclusion Criteria:
- Preoperative urinary incontinence or neurogenic bladder dysfunction
- Previous prostate surgery or prior anti-incontinence surgery
- Urethral stricture disease or bladder neck contracture
- Active urinary tract infection at the time of enrollment
- Severe cognitive impairment preventing compliance with PFMT instructions
- Neurological disorders affecting lower urinary tract function, including Parkinson disease, multiple sclerosis, spinal cord injury, or cerebrovascular stroke with residual deficits
- Implanted electronic or metallic devices contraindicating magnetic stimulation, including cardiac pacemaker, implantable cardioverter-defibrillator, neurostimulators, or cochlear implants
- Uncontrolled diabetes mellitus with severe neuropathy
- Receiving concurrent therapies for urinary incontinence during the study period
- Persistent postoperative complications requiring reintervention (e.g., severe hematuria, clot retention)
- Inability or refusal to complete follow-up evaluations
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 |
|---|---|
|
실험적: Electromagnetic Pelvic Floor Stimulation (ExMI + PFMT)
Patients receive standard pelvic floor muscle training (three daily sessions, each with 10 slow contractions of 5-10 seconds and 10 rapid contractions, continued for 12 weeks postoperatively) plus extracorporeal magnetic stimulation using a magnetic chair device, administered twice weekly for 20-30 minutes per session over 6-8 weeks, at an intensity adjusted to patient tolerance.
|
Non-invasive pelvic floor and pudendal nerve stimulation delivered via a magnetic chair device, twice weekly for 20-30 minutes per session over 6-8 weeks.
Supervised pelvic floor muscle training consisting of three daily sessions (10 slow contractions of 5-10 seconds and 10 rapid contractions per session), continued for 12 weeks postoperatively, with biofeedback assistance.
|
|
활성 비교기: Biofeedback-Assisted Pelvic Floor Muscle Training
Patients receive standard pelvic floor muscle training (three daily sessions, each with 10 slow contractions of 5-10 seconds and 10 rapid contractions, continued for 12 weeks postoperatively) with biofeedback assistance, without extracorporeal magnetic stimulation.
|
Supervised pelvic floor muscle training consisting of three daily sessions (10 slow contractions of 5-10 seconds and 10 rapid contractions per session), continued for 12 weeks postoperatively, with biofeedback assistance.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to Recovery of Urinary Continence
기간: Up to 6 months postoperatively
|
Continence is defined as no pad use or use of one security pad with no significant leakage.
Time from catheter removal to achievement of continence will be recorded for each participant.
|
Up to 6 months postoperatively
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Pad Usage
기간: Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
|
Number of pads used per day, assessed at each follow-up visit.
|
Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
|
|
Change in 24-Hour Pad Test Result
기간: Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
|
Objective urine leakage measured in grams over a 24-hour period.
|
Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
|
|
Change in ICIQ-UI SF Score
기간: Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
|
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score, assessing severity and impact of urinary incontinence.
|
Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
|
|
Change in Quality of Life (QoL) Score
기간: Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
|
Quality of life score assessed at each follow-up visit.
|
Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
|
|
Incidence of Treatment-Related Adverse Events
기간: Up to 6 months postoperatively
|
Number and type of complications or adverse events related to pelvic floor muscle training or extracorporeal magnetic stimulation.
|
Up to 6 months postoperatively
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Esraa Abdelhamid Elshintenawy, MD, Tanta University Faculty of Medicine
- 수석 연구원: Mona Helal Omara, MD, Tanta University Faculty of Medicine
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.
- Elmansy HM, Kotb A, Elhilali MM. Holmium laser enucleation of the prostate: long-term durability of clinical outcomes and complication rates during 10 years of followup. J Urol. 2011 Nov;186(5):1972-6. doi: 10.1016/j.juro.2011.06.065. Epub 2011 Sep 23.
- Yamanishi T, Mizuno T, Watanabe M, Honda M, Yoshida K. Randomized, placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy. J Urol. 2010 Nov;184(5):2007-12. doi: 10.1016/j.juro.2010.06.103. Epub 2010 Sep 20.
- Galloway NT, El-Galley RE, Sand PK, Appell RA, Russell HW, Carlan SJ. Extracorporeal magnetic innervation therapy for stress urinary incontinence. Urology. 1999 Jun;53(6):1108-11. doi: 10.1016/s0090-4295(99)00037-0.
- Van Kampen M, De Weerdt W, Van Poppel H, De Ridder D, Feys H, Baert L. Effect of pelvic-floor re-education on duration and degree of incontinence after radical prostatectomy: a randomised controlled trial. Lancet. 2000 Jan 8;355(9198):98-102. doi: 10.1016/S0140-6736(99)03473-X.
- Anderson CA, Omar MI, Campbell SE, Hunter KF, Cody JD, Glazener CM. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev. 2015 Jan 20;1(1):CD001843. doi: 10.1002/14651858.CD001843.pub5.
- Herrmann TR, Liatsikos EN, Nagele U, Traxer O, Merseburger AS; EAU Guidelines Panel on Lasers, Technologies. EAU guidelines on laser technologies. Eur Urol. 2012 Apr;61(4):783-95. doi: 10.1016/j.eururo.2012.01.010. Epub 2012 Jan 17.
- Krambeck AE, Handa SE, Lingeman JE. Experience with more than 1,000 holmium laser prostate enucleations for benign prostatic hyperplasia. J Urol. 2013 Jan;189(1 Suppl):S141-5. doi: 10.1016/j.juro.2012.11.027.
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)
2026년 7월 1일
기본 완료 (추정된)
2027년 6월 1일
연구 완료 (추정된)
2027년 6월 1일
연구 등록 날짜
최초 제출
2026년 7월 7일
QC 기준을 충족하는 최초 제출
2026년 7월 7일
처음 게시됨 (실제)
2026년 7월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 7일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 36265PR74/5/26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
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. .
양성 전립선 비대증에 대한 임상 시험
-
Silkiss Eye SurgeryJazz Pharmaceuticals; Smith-Kettlewell Eye Research Institute; Benign Essential Blepharospasm...완전한
-
University of PennsylvaniaRevance Therapeutics, Inc.아직 모집하지 않음안검경련 | Blepharospasm, Benign Essential | 왼쪽 눈꺼풀의 안검 경련 | 오른쪽 눈꺼풀의 안검 경련 | 양쪽 눈꺼풀의 안검 경련미국
Extracorporeal Magnetic Stimulation (ExMI)에 대한 임상 시험
-
Hospital Center Guillaume Régnier모병