Benign Prostatic Hypertrophy Clinical Trial
— MOSESOfficial 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.
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | August 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University Hospital, Bordeaux |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patient who discharge on D0 (same day of his surgery) | baseline | ||
Primary | Number of hour's hospitalization | baseline | ||
Secondary | Number of hour's surgery time | baseline | ||
Secondary | Rate of enucleated prostate tissue By time treatment per patient | baseline | ||
Secondary | number of minutes use of the LASER during surgery | baseline | ||
Secondary | quantity of energy used during the intervention per patient | baseline | ||
Secondary | Intraoperative transfusion rate | baseline | ||
Secondary | Duration of post-operative sounding (hours) | baseline | ||
Secondary | Readmission rate within 48 hours of discharge from hospital | baseline | ||
Secondary | Mean change in IPSS before surgery and 3 months after surgery | 3 months after surgery | ||
Secondary | Mean change in QoL before surgery and 3 months after surgery | 3 months after surgery | ||
Secondary | Mean change in IIEF-5 before surgery and 3 months after surgery | 3 months after surgery | ||
Secondary | Mean change in ICIQ-short form score before surgery and 3 months after surgery | 3 months after surgery | ||
Secondary | Mean change in USP before surgery and 3 months after surgery | 3 months after surgery | ||
Secondary | Mean evolution of Qmax and post-void residual (RPM) before the intervention and at 3 months post-operative | 3 months after surgery |
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