Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP): Efficacy and Safety

Prostatic Hyperplasia Clinical Trial

Official title:

Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP): Short-Term Efficacy and Safety Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03554070
• Other study ID #: Sechenov-ThuFLEP18
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: September 1, 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 aim of our study is to estimate the efficacy, safety and postoperative complications of the thulium fiber laser enucleation of the prostate (ThuFLEP) with Urolase system (NTO IRE-POLUS, Russia).

Description:

In all patients, IPSS, Qmax, QoL, prostate volume, and IIEF-5 are measured prior to surgery.

For ThuFLEP, we use the Urolase system (NTO IRE-POLUS, Russia) and a 600 mcm fiber. The thulium fiber laser is set with a mean output power of 60 W and energy of 1.5 J. Tissue morcellation is completed with the Piranha Morcellator (Richard Wolf, Germany).

At the end of the procedure a 22 French three-way Foley catheter is placed. IPSS, Qmax, QoL, prostate volume are recorded at 1, 3 and 6 months after surgery. IIEF-5 are recorded at 3 and 6 months after surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: September 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men aged 18 or older

• Infravesical obstruction due to prostatic hyperplasia (IPSS > 20 or Qmax <10)

Exclusion Criteria:

• Participation in another clinical study

• Prostate cancer (pathology confirmed)

• Urinary tract infection

• Neurogenic bladder

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• Thulium Fiber Laser Enucleation of the Prostate
Thulium laser enucleation of the prostate is performed using the two-lobe or en-bloc techniques. Incision depth is limited to the circular fibers of the prostate capsule. The left lobe is enucleated first, starting at the 5 o'clock position. The endoscope is then introduced counterclockwise at the 2 o'clock position. Next, an incision is made at 12 o'clock and extended to the level of the verumontanum. The incisions at the 12 and 2 o'clock positions are connected, and the left lobe is enucleated into the bladder. The right lobe of the gland is enucleated in a similar manner: the initial incision at 7 o'clock was made clockwise, an 11 o'clock incision is then extended along the capsule to join with the previous cut. The final step is morcellation of hyperplastic nodes.

Device:
• Thulium Fiber Laser "Urolase"
Urolase system (NTO IRE-POLUS, Russian Federation) is a thulium doped fiber laser. Max. power of 120 W and energy of 8 J. Wavelength - 1,94 µm, incision depth - 0,2 mm.

Locations

Country	Name	City	State
Russian Federation	Clinic of Urology, I.M. Sechenov First Moscow State Medical University	Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

Enikeev D, Glybochko P, Okhunov Z, Alyaev Y, Rapoport L, Tsarichenko D, Enikeev M, Sorokin N, Dymov A, Taratkin M. Retrospective Analysis of Short-Term Outcomes After Monopolar Versus Laser Endoscopic Enucleation of the Prostate: A Single Center Experience. J Endourol. 2018 May;32(5):417-423. doi: 10.1089/end.2017.0898. Epub 2018 Mar 13. — View Citation

Glybochko PV, Rapoport LM, Enikeev ME, Enikeev DV. Holmium laser enucleation of the prostate (HoLEP) for small, large and giant prostatic hyperplasia: tips and tricks. Urologia. 2017 Aug 1;84(3):169-173. doi: 10.5301/uj.5000232. Epub 2017 May 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline IPSS at 1,3 and 6 months	International Prostate Symptom Score	baseline and at 1,3 and 6 months
Primary	Change from Baseline Qmax at 1,3 and 6 months	Maximal urinary flow rate	baseline and at 1,3 and 6 months
Secondary	Change from Baseline QoL at 1,3 and 6 months	Quality of Life (IPSS-QoL scale)	baseline and at 1,3 and 6 months
Secondary	Change from Baseline IIEF-5 at 3 and 6 months	The International Index of Erectile Function - 5	baseline and at 3 and 6 months
Secondary	Change from Baseline Prostate Volume at 1,3 and 6 months	Prostate volume measured by ultrasound (transrectal or abdominal)	baseline and at 1,3 and 6 months