PUL vs TURP in BPH Patients With Urinary Retention

Официальное название

Prostatic Urethral Lift Versus Transurethral Resection of Prostate in Benign Prostatic Hyperplasia Patients With Urinary Retention

Обзор

The study will be a prospective, randomized controlled trial comparing prostatic urethral lift (PUL) versus transurethral resection of prostate (TURP) in benign prostate hyperplasia (BPH) patients with urinary retention. The primary objective of this study is to compare the catheter-free rates of PUL vs TURP. Secondary objectives include comparison of complications rates, cost effectiveness, patient satisfactory, symptom scores, quality of life measures and urodynamic parameters.

Подробное описание

The study will be a prospective, non-inferiority randomized controlled trial with the aim of detecting a non-inferiority margin of 5%.

After the potential subject has been informed of the study and the potential risks, he will be screened for eligibility within a 4 week period. Assessment of eligibility will include questionnaires, blood tests, urine tests, uroflowmetry, flexible cystoscopy, transrectal ultrasound, and urodynamic study. Suitable subjects will then be randomized in a 1:1 ratio to the prostatic urethral lift (intervention group) and TURP (control group). Patients in the prostatic urethral lift will have the procedure performed under local anesthesia or monitored anesthetic care while TURP patients will be performed under spinal or general anesthesia. The subjects will have regular follow up 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-operatively. Follow up assessments will include questionnaires, uroflowmetry, and occasional urodynamic study.

Вмешательства

• Устройство Prostatic Urethral Lift
  Prostatic urethral lift uses permanent implants to retract the prostate lobes away from the prostate urethra to allow unobstructed passage of urine. These implants are made of Nitinol, non-absorbable monofilament suture material (Poly Ethylene Terephthalate), Stainless Steel
• Процедура TURP
  Using monopolar or bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH

Первичные конечные точки

• Catheter-free rates after prostatic urethral lift versus TURP in BPH patients with urinary retention [Срок оценки: 1 year after intervention]

Вторичные конечные точки (12)

• Compare complication rate of prostatic urethral lift versus TURP in BPH patients with urinary retention [Срок оценки: 5 years]
• Cost effectiveness of prostatic urethral lift versus TURP in achieving catheter-free rates in BPH patients with urinary retention [Срок оценки: 1 year]
• Compare patient satisfaction by PGI-I questionnaire after prostatic urethral lift versus TURP [Срок оценки: 1 year]
• Compare patient reported symptom measures by IPSS questionnaire after prostatic urethral lift versus TURP [Срок оценки: 1 year]
• Compare patient reported symptom measures by ISI questionnaire after prostatic urethral lift versus TURP [Срок оценки: 1 year]
• Compare patient reported symptom measures by IIEF-5 questionnaire after prostatic urethral lift versus TURP [Срок оценки: 1 year]
• Compare patient reported symptom measures by MSHQ-EjD short form questionnaire after prostatic urethral lift versus TURP [Срок оценки: 1 year]
• Compare patient reported quality of life by SF-12 questionnaire after prostatic urethral lift versus TURP [Срок оценки: 1 year]
• Compare patient reported quality of life by derived SF-6D utility score after prostatic urethral lift versus TURP [Срок оценки: 1 year]
• Compare patient reported recovery by VAS after prostatic urethral lift versus TURP [Срок оценки: 1 year]
• Compare improvement bladder contractility index after prostatic urethral lift versus TURP [Срок оценки: 5 year]
• Compare improvement of Bladder outflow obstruction index after prostatic urethral lift versus TURP [Срок оценки: 5 year]

Критерии участия

Критерии включения

• Male patients
• age >40 years old
• urinary retention who failed trial without catheter

Критерии исключения

• Inability to provide consent OR no guardians or relatives to help provide consent on patient's behalf
• Active urinary tract infection
• Previous surgical treatment for benign prostatic hyperplasia (i.e., TURP, prostatic urethral lift, etc.)
• Bladder stones
• Urethral strictures or bladder neck contractures
• Prostate size >100mL
• Solely obstructing median lobe
• Urinary retention not due to obstruction (i.e., Bladder outflow obstruction index <20 on urodynamic studies)
• Poor detrusor contractility (maximum detrusor pressure <20cmH2O during voiding phase)
• Anticoagulant or antiplatelet agents that cannot be stopped

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Queen Mary Hospital — Гонконг

Публикации

• Garraway WM, Collins GN, Lee RJ. High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991 Aug 24;338(8765):469-71. doi: 10.1016/0140-6736(91)90543-x. PMID 1714529
• Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, Lieber MM. Treatment for benign prostatic hyperplasia among community dwelling men: the Olmsted County study of urinary symptoms and health status. J Urol. 1999 Oct;162(4):1301-6. PMID 10492184
• Madersbacher S, Marberger M. Is transurethral resection of the prostate still justified? BJU Int. 1999 Feb;83(3):227-37. doi: 10.1046/j.1464-410x.1999.00908.x. No abstract available. PMID 10233485
• Mebust WK, Holtgrewe HL, Cockett AT, Peters PC. Transurethral prostatectomy: immediate and postoperative complications. a cooperative study of 13 participating institutions evaluating 3,885 patients. 1989. J Urol. 2002 Feb;167(2 Pt 2):999-1003; discussion 1004. No abstract available. PMID 11908420
• Neal DE. The National Prostatectomy Audit. Br J Urol. 1997 Apr;79 Suppl 2:69-75. doi: 10.1111/j.1464-410x.1997.tb16924.x. No abstract available. PMID 9126073
• Woo HH, Chin PT, McNicholas TA, Gill HS, Plante MK, Bruskewitz RC, Roehrborn CG. Safety and feasibility of the prostatic urethral lift: a novel, minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU Int. 2011 Jul;108(1):82-8. doi: 10.1111/j.1464-410X.2011.10342.x. Epub 2011 May 6. PMID 21554526
• Walsh LP. State of the art: Advanced techniques for prostatic urethral lift for the relief of prostate obstruction under local anesthesia. Can J Urol. 2017 Jun;24(3):8859-8864. PMID 28646943
• Eure G, Gange S, Walter P, Khan A, Chabert C, Mueller T, Cozzi P, Patel M, Freedman S, Chin P, Ochs S, Hirsh A, Trotter M, Grier D. Real-World Evidence of Prostatic Urethral Lift Confirms Pivotal Clinical Study Results: 2-Year Outcomes of a Retrospective Multicenter Study. J Endourol. 2019 Jul;33(7):576-584. doi: 10.1089/end.2019.0167. Epub 2019 Jun 25. PMID 31115257

Идентификаторы

NCT: NCT06037356 · QMH PULTUR Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗