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NCT Number: NCT05768776

Outpatient Holmium LASER Enucleation of the Prostate: Benefit of MOSES(TM) 2.0 Technology

The aim of this study is to compare the success rate of outpatient surgery after holmium LASER enucleation of the prostate (HoLEP) for the treatment of BPH with and without the use of the MOSES 2.0 effect.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Benign Prostatic Hypertrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Genital Diseases Genital Diseases, Male Holmium Laser Enucleation of the Prostate Male Urogenital Diseases Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

CHU de Bordeaux

Bordeaux, 33075, France

About this study

HoLEP is in the process of becoming the new reference surgical treatment for BPH with the main advantages over monopolar transurethral resection (TURPm) and high approach adenomectomy (AVH): the significant reduction in morbidity perioperative period and therefore the reduction in the length of hospital stay. This reduction in length of stay has led to the development of outpatient care with encouraging results. The main cause of discharge failure on D0 is the persistence of postoperative hematuria requiring maintenance of bladder irrigation. MOSESTM 2.0 technology has the advantage of better hemostasis compared to the LASER LP100 currently used. The objective of this study is to evaluate the influence of MOSESTM 2.0 technology on the outpatient success rate in patients operated on for HoLEP for BPH.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject over 50 years old
  • BPH whose symptoms require surgical management
  • Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) ≥ 40g
  • IPSS score > 15 and Quality of Life score ≥ 3
  • Maximum urinary output (Qmax) < 15 ml/sec

Exclusion criteria

  • Inability to read or write French
  • Patients with comorbidities contraindicating general anesthesia
  • Patients not eligible for outpatient care according to French recommendations (high risk of complications after general anesthesia, place of residence more than 150 km from an emergency department, alone at home the night following the intervention) .
  • History of BPH surgery
  • History of prostate cancer
  • Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) < 40g
  • Existence or history of urethral stricture
  • Existence or suspicion of a "neurological" bladder
  • Positive preoperative cytobacteriological examination not treated appropriately
  • Adult patients subject to a legal protection measure or unable to express their consent
  • Patients deprived of liberty by a judicial or administrative decision or hospitalized without consent or admitted to a health or social establishment for purposes other than research

Treatment and study plan

HoLEP patients without MOSES(TM) 2.0 effect (open label)

Procedure

HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, without using MOSES technology

HoLEP patients with MOSES(TM) 2.0 effect (open label)

Procedure

HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, with the use of MOSES technology

Primary outcomes

  1. Number of patient who discharge on D0 (same day of his surgery)

    Time frame: baseline

  2. Number of hour's hospitalization

    Time frame: baseline

Secondary outcomes

  1. Number of hour's surgery time

    Time frame: baseline

  2. Rate of enucleated prostate tissue By time treatment per patient

    Time frame: baseline

  3. number of minutes use of the LASER during surgery

    Time frame: baseline

  4. quantity of energy used during the intervention per patient

    Time frame: baseline

  5. Intraoperative transfusion rate

    Time frame: baseline

  6. Duration of post-operative sounding (hours)

    Time frame: baseline

  7. Readmission rate within 48 hours of discharge from hospital

    Time frame: baseline

  8. Mean change in IPSS before surgery and 3 months after surgery

    Time frame: 3 months after surgery

  9. Mean change in QoL before surgery and 3 months after surgery

    Time frame: 3 months after surgery

  10. Mean change in IIEF-5 before surgery and 3 months after surgery

    Time frame: 3 months after surgery

  11. Mean change in ICIQ-short form score before surgery and 3 months after surgery

    Time frame: 3 months after surgery

  12. Mean change in USP before surgery and 3 months after surgery

    Time frame: 3 months after surgery

  13. Mean evolution of Qmax and post-void residual (RPM) before the intervention and at 3 months post-operative

    Time frame: 3 months after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

To Compare the Effectiveness of the MOSES 2.0 Technology to the Non-MOSES Technology on the Success Rate of Holmium LASER Enucleation of the Prostate (HoLEP) Performed on an Outpatient Basis in the Context of Benign Prostatic Hypertrophy.

Acronym: MOSES

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2023
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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