BPH With Urinary Obstruction Clinical Trial
— PULTUROfficial title:
Prostatic Urethral Lift Versus Transurethral Resection of Prostate in Benign Prostatic Hyperplasia Patients With Urinary Retention
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 30, 2032 |
Est. primary completion date | May 30, 2031 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Male patients - age >40 years old - urinary retention who failed trial without catheter Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Queen Mary Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Queen Mary Hospital, Hong Kong |
China,
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 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
McVary KT, Gange SN, Shore ND, Bolton DM, Cowan BE, Brown BT, Te AE, Chin PT, Rukstalis DB, Roehrborn CG; L.I.F.T. Study Investigators. Treatment of LUTS secondary to BPH while preserving sexual function: randomized controlled study of prostatic urethral — View Citation
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. — View Citation
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. — View Citation
Roehrborn CG, Barkin J, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, Cantwell AL, McVary KT, Te AE, Gholami SS, Moseley WG, Chin PT, Dowling WT, Freedman SJ, Incze PF, Coffield KS, Herron S, Rashid P, Rukstalis DB. Five year results of the prospec — View Citation
Sievert KD, Schonthaler M, Berges R, Toomey P, Drager D, Herlemann A, Miller F, Wetterauer U, Volkmer B, Gratzke C, Amend B. Minimally invasive prostatic urethral lift (PUL) efficacious in TURP candidates: a multicenter German evaluation after 2 years. Wo — View Citation
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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Catheter-free rates after prostatic urethral lift versus TURP in BPH patients with urinary retention | To determine how many patients will be catheter-free (defined as by the ability to void with a post-void residual urine <300mL) after intervention and remain catheter-free at 1 month, 3 months, and 1 year after intervention | 1 year after intervention | |
Secondary | Compare complication rate of prostatic urethral lift versus TURP in BPH patients with urinary retention | To determine the percentage and severity of complications after each intervention (according to the Clavien-Dindo classification) | 5 years | |
Secondary | Cost effectiveness of prostatic urethral lift versus TURP in achieving catheter-free rates in BPH patients with urinary retention | To determine the cost required to achieve catheter free patients for each intervention (including hospitalization, anesthetic costs, equipment, consumables, etc) | 1 year | |
Secondary | Compare patient satisfaction by PGI-I questionnaire after prostatic urethral lift versus TURP | Using the Patient global impression of improvement (PGI-I) questionnaire to determine patient satisfaction after each intervention.
minimum score is 1, maximum score is 7 higher score means worse outcome |
1 year | |
Secondary | Compare patient reported symptom measures by IPSS questionnaire after prostatic urethral lift versus TURP | Using International prostate symptom score (IPSS) questionnaire to determine patient reported symptom measure after each intervention
minimal score: 0, maximum score is 35 higher score means worse outcome |
1 year | |
Secondary | Compare patient reported symptom measures by ISI questionnaire after prostatic urethral lift versus TURP | Using the Incontinence severity index (ISI) questionnaire to determine patient reported symptom measure after each intervention
minimum score: 1, maximum score: 12 higher score means worse outcome |
1 year | |
Secondary | Compare patient reported symptom measures by IIEF-5 questionnaire after prostatic urethral lift versus TURP | Using the International index of erectile function- 5 items (IIEF-5) questionnaire to determine patient reported symptom measure after each intervention
minimum score: 1, maximum score: 25 higher score means better outcome |
1 year | |
Secondary | Compare patient reported symptom measures by MSHQ-EjD short form questionnaire after prostatic urethral lift versus TURP | Using the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) short form questionnaire to determine patient reported symptom measure after each intervention. | 1 year | |
Secondary | Compare patient reported quality of life by SF-12 questionnaire after prostatic urethral lift versus TURP | Using the Short Form 12 (SF-12) questionnaire to determine patient reported quality of life measures after each intervention
minimum score: 0, maximum score: 100 higher score means better outcome |
1 year | |
Secondary | Compare patient reported quality of life by derived SF-6D utility score after prostatic urethral lift versus TURP | Using the derived Short Form 6 Dimension (SF-6D) utility score questionnaire to determine patient reported quality of life measures after each intervention
minimum score: 0, maximum score 1.0 higher score means better outcome |
1 year | |
Secondary | Compare patient reported recovery by VAS after prostatic urethral lift versus TURP | Using the Visual analogue scale of quality of recovery to determine patient reported recovery after each intervention
minimum score: 0, maximum score 100 higher score means better outcome |
1 year | |
Secondary | Compare improvement bladder contractility index after prostatic urethral lift versus TURP | Pre- and post-intervention urodynamic will be performed to assess bladder contractility index as well as subsequent improvement and durability of above stated urodynamic parameter after each intervention | 5 year | |
Secondary | Compare improvement of Bladder outflow obstruction index after prostatic urethral lift versus TURP | Pre- and post-intervention urodynamic will be performed to assess bladder outflow obstruction index (BOOI) as well as subsequent improvement and durability of above stated urodynamic parameter after each intervention | 5 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT02961114 -
Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy
|
Phase 1/Phase 2 | |
Completed |
NCT03998150 -
Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study
|
N/A | |
Completed |
NCT03280420 -
Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to BPH Under Tamsulosin Treatment
|
N/A | |
Enrolling by invitation |
NCT03589196 -
Ejaculation Preserving Photoselective Vaporization Versus Plasma Kinetic Vaporization Versus Transurethral Resection Of The Prostate: A RCT
|
N/A | |
Recruiting |
NCT05620784 -
Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP
|
Phase 3 | |
Terminated |
NCT03605745 -
Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL)
|
N/A | |
Recruiting |
NCT06101576 -
Readmission Following Prostatic Surgery
|
||
Completed |
NCT04143399 -
HoLEP vs BPRP of a Large Volume BPH: a Randomised Controlled Trial
|
N/A | |
Recruiting |
NCT04102566 -
Optimizing Pain Control in Transurethral Resection of the Prostate
|
Phase 4 | |
Completed |
NCT04935151 -
HoLEP vs BPRP in the Management of a Large Volume (> 80 gm) Symptomatic BPH
|
N/A | |
Recruiting |
NCT05652023 -
Noninvasive Ultrasound Assessment of Detrusor Dysfunction
|