Clinical trial NCT04342533: Prospective Randomized Trial of Irritative Symptoms Severity Assessment After (HoLEP) Versus ThuFLEP
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).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: BPH
Prostate Obstruction
Keywords: HoLEP
ThuFLEP
EEP
prostate enucleation
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 140
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: severity of urinary incontinence
timeFrame: change from 1 week to 6 months after surgery
Secondary outcomes:
measure: rate of intra- and perioperative adverse events
timeFrame: 6 months follow up
measure: surgery duration
timeFrame: during surgery
measure: hemoglobin drop
timeFrame: 1 day after surgery
measure: catheter stay
timeFrame: 1 week after surgery
measure: hospitalization length
timeFrame: 1 week after surgery
measure: functional outcomes
timeFrame: change from 3 to 6 months after surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute for Urology and Reproductive Health, Sechenov University.
Study officials:
References: