PUL vs TURP in BPH Patients With Urinary Retention

BPH With Urinary Obstruction Clinical Trial

— PULTUR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037356
• Other study ID #: QMH PULTUR Study
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: May 30, 2032

Study information

• Verified date: April 2024
• Source: Queen Mary Hospital, Hong Kong
• Contact: Brian SH Ho, MBBS
• Phone: (852)2255-3023
• Email: hobrian[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• BPH With Urinary Obstruction
• Urinary Retention

Intervention

Device:
• 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

Procedure:
• 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

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

China, 

References & Publications (11)

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

Outcome

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

External Links

•   2016 Hong Kong Population By-census results reveal latest demographic trends [Internet]. Census and Statistics Department