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

NCT ID: NCT04342533

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2021-10-10

Brief Summary

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.

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.

Conditions

BPH; Prostate Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ThuFLEP

Patients who underwent thulium fiber enucleation of the prostate

Group Type: EXPERIMENTAL

Thulium fiber laser enucleation of the prostate

Intervention Type: PROCEDURE

enucleation of the BPH according to standard procedure protocol

HoLEP

Patients who underwent holmium laser enucleation of the prostate

Group Type: ACTIVE_COMPARATOR

Holmium laser enucleation of the prostate

Intervention Type: PROCEDURE

enucleation of the BPH according to standard procedure protocol

Interventions

Thulium fiber laser enucleation of the prostate

enucleation of the BPH according to standard procedure protocol

Intervention Type: PROCEDURE

Holmium laser enucleation of the prostate

enucleation of the BPH according to standard procedure protocol

Intervention Type: PROCEDURE

Other Intervention Names

ThuFLEP; HoLEP

Eligibility Criteria

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.

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Dmitry Enikeev, MD, PhD

Deputy director for research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, , Russia

Countries

Russia

Other Identifiers

Sechenov-Ho_Vs_TFL-20

Identifier Type: -

Identifier Source: org_study_id