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PUL vs TURP in BPH Patients With Urinary Retention

ConditionBPH With Urinary Obstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorQueen Mary Hospital, Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male patients

age >40 years old

urinary retention who failed trial without catheter

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prostatic Urethral Lift

    Device

    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

  • TURP

    Procedure/Surgery

    Using monopolar or bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Prostatic Urethral LiftExperimental treatment 1 intervention
Group B: TURPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 year after intervention

Secondary outcomes

1

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)

Time frame
5 years
2

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)

Time frame
1 year
3

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

Time frame
1 year
4

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

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Queen Mary Hospital, Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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