Prospective Randomized Trial of Irritative Symptoms Severity Assessment After (HoLEP) Versus ThuFLEP (PRISSA)

Prospective Randomized Trial of Irritative Symptoms Severity Assessment After Holmium Laser Enucleation of the Prostate (HoLEP) Versus Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP).

The investigators hypothesize that the functional outcomes of both techniques are comparable. However, ThuFLEP might increase speed recovery of postoperative irritation and early stress urinary incontinence according to the Questionnaire for Urinary Incontinence Diagnosis (QUID) because of minimal tissue penetration depth of TFL.

Study Overview

• Status: Enrolling by invitation
• Conditions: BPH; Prostate Obstruction
• Intervention / Treatment: Procedure: Thulium fiber laser enucleation of the prostate; Procedure: Holmium laser enucleation of the prostate

Detailed Description

Thulium fiber laser enucleation of the prostate (ThuFLEP) has already shown the outcomes comparable to OSP with better safety profile (lower blood loss compared to OSP) and shorter hospital stay. TFL has the efficacy and safety proven in comparative trials, being a promising rival for HoLEP. The main features of TFL distinguishing it from Ho:YAG is its wavelength of 1.94 µm (leading to about three-fold increase in water absorption and lesser penetration depth of <0.1 mm vs >0.2 mm in Ho:YAG). With identical average and peak powers of 100 W, the laser does not burst tissues, allowing for clean and precise cutting instead. Conversely, Ho:YAG's average power is about 100 W and its presumable peak power is around 10-15 kW. With such an outburst of energy, each pulse of Ho:YAG creates a large vapor bubble which ruptures the tissue. This may be a possible reason for increased irritative symptoms in early postoperative period after HoLEP comparing to ThuFLEP. But all in all, the probable causes for such postoperative symptoms remain unclear so far, despite the fact that absence of irritation and incontinence is ought to be one quality marker of "Pentafecta". According to the idea of high-power impact, probably, decreasing of HoLEP power will mitigate these problems. On the one hand, low-power HoLEP is feasible, safe and effective modality for symptomatic BPO. However, the results remain controversial and there is lack of LP-HoLEP application data nowadays. May be, with another option, for instance OSP or monopolar enucleation, it is possible to solve the issues. But the discussion of the past years demonstrates that the presence of early SUI is not only a problem of EEP, but also underreported in other approaches in relieving BPO secondary to BPH.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Institute for Urology and Reproductive Health, Sechenov University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• LUTS presence, proven by:

  1. IPSS questionnaire (Score >20);
  2. OR uroflowmetry result (Qmax <10 ml/s);

Exclusion Criteria:

• Prostate volume > 120 cc
• Prostate cancer on pathology;
• Urethral strictures;
• Bladder calculi;
• Prior prostate surgery;
• Neurogenic bladder dysfunction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ThuFLEP; Patients who underwent thulium fiber enucleation of the prostate	Procedure: Thulium fiber laser enucleation of the prostate; enucleation of the BPH according to standard procedure protocol; Other Names: ThuFLEP
Active Comparator: HoLEP; Patients who underwent holmium laser enucleation of the prostate	Procedure: Holmium laser enucleation of the prostate; enucleation of the BPH according to standard procedure protocol; Other Names: HoLEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of urinary incontinence	Questionnaire for Urinary Incontinence Diagnosis (higher score means worse incontinence)	change from 1 week to 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of intra- and perioperative adverse events	complications according to Clavien-Dindo classification (higher score means more severe complication)	6 months follow up
surgery duration	lengths of the procedure	during surgery
hemoglobin drop	decrease of hemoglobin at the first day after surgery comparing to preoperative value	1 day after surgery
catheter stay	lengths of catheterization	1 week after surgery
hospitalization length	duration of staying at hospital after the surgery	1 week after surgery
functional outcomes	IPSS (international prostate symptos score), QoL (quality of life), IIEF-5 (international index of erectile function) questionaries, Qmax	change from 3 to 6 months after surgery

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): July 10, 2021
• Study Completion (Anticipated): October 10, 2021

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: prostate enucleation; HoLEP; EEP; ThuFLEP
• Other Study ID Numbers: Sechenov-Ho_Vs_TFL-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No