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

BPH Clinical Trial

— PRISSA  

Official title:

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).

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04342533
• Other study ID #: Sechenov-Ho_Vs_TFL-20
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: October 10, 2021

Study information

• Verified date: July 2021
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 140
• Est. completion date: October 10, 2021
• Est. primary completion date: July 10, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• BPH
• Prostate Obstruction

Intervention

Procedure:
• Thulium fiber laser enucleation of the prostate
enucleation of the BPH according to standard procedure protocol
• Holmium laser enucleation of the prostate
enucleation of the BPH according to standard procedure protocol

Locations

Country	Name	City	State
Russian Federation	Institute for Urology and Reproductive Health, Sechenov University.	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of urinary incontinence	Questionnaire for Urinary Incontinence Diagnosis (higher score means worse incontinence)	change from 1 week to 6 months after surgery
Secondary	rate of intra- and perioperative adverse events	complications according to Clavien-Dindo classification (higher score means more severe complication)	6 months follow up
Secondary	surgery duration	lengths of the procedure	during surgery
Secondary	hemoglobin drop	decrease of hemoglobin at the first day after surgery comparing to preoperative value	1 day after surgery
Secondary	catheter stay	lengths of catheterization	1 week after surgery
Secondary	hospitalization length	duration of staying at hospital after the surgery	1 week after surgery
Secondary	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