Prostatic Hyperplasia, Benign Clinical Trial
— ENUPLASMHOOfficial title:
Observational Study to Compare Two Prostate Laser Enucleation Techniques (Photo-vaporization of the Prostate (PLASMA) Versus HoLEP) in Terms of Overall Post-operative Urinary Incontinence
NCT number | NCT05157724 |
Other study ID # | ENUPLASMHO |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | November 2021 |
Est. completion date | November 2026 |
Verified date | February 2024 |
Source | Elsan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Benign prostatic hypertrophy or prostatic adenoma is a benign tumour that develops in the central part of the prostate. Prostatic adenoma can result in the progressive appearance of a difficulty in evacuating the bladder or frequent urges to urinate and other complications (lithiasis, haematuria, urinary retention, etc.). Surgery is indicated when medical treatment is no longer effective and in the case of complications. The endoscopic techniques for treating prostate adenoma, PLASMA and HOLEP, are recognised and recommended by the French Association of Urology and the European Association of Urology (EAU) as Gold Standard techniques in view of the good results reported in the literature, the low rate of complications compared to the other techniques, and the reduced hospitalisation rate. For prostate volumes less than 80cc, there is no difference between HOLEP and Bipolar Plasma Enucleation of the Prostate (BTUEP) in terms of International Prostate Symptom Score (IPSS), Qmax, and reoperation rate at 12 months. The surgeon's experience is the most important factor influencing the risk of complications for HOLEP. Urinary incontinence after HOLEP according to Houssin et al. is 14.5% at 3 months and 4.2% at 6 months, the risk factors identified were surgeon experience and the existence of diabetes. Comparative evaluation of the two techniques is less frequent, hence the interest of our prospective and multicentre study. In this study, the investigators hope to demonstrate a better outcome of the PLASMA technique in terms of post-operative residual urinary incontinence.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2026 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Men aged 18 years or more and less than 80 years, - Prostate volume 30-80 cc inclusive - Patient who has failed medical treatment for his prostate adenoma, - Indication for prostate enucleation (HOLEP or PLASMA) - Patient who was informed of the study and did not object Exclusion Criteria: - Patient with a diagnosis of prostate cancer, - Patient requiring monopolar or bipolar endoscopic resection, - Patient under legal protection |
Country | Name | City | State |
---|---|---|---|
France | ELSAN Pôle Santé République - Urology | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
Elsan |
France,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall urinary incontinence (including stress urinary incontinence and urgency) between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit | Pad weight testing during 3 consecutive days | At 3 months post surgery | |
Secondary | Overall urinary incontinence (including stress urinary incontinence and urgency) between the two prostate enucleation procedures PLASMA and HOLEP at 1 year visit | Pad weight testing during 3 consecutive days | At 1 year post surgery | |
Secondary | Urinary incontinence evaluated by urinary symptom profile questionnaire between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit | Urinary symptom profile questionnaire | At 3 months post surgery | |
Secondary | Urinary incontinence evaluated by urinary symptom profile questionnaire between the two prostate enucleation procedures PLASMA and HOLEP at 1-year visit | Urinary symptom profile questionnaire | At 1 year post surgery | |
Secondary | Functional evaluation evaluated by uroflowmetry between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit | Uroflowmetry | At 3 months post surgery | |
Secondary | Functional evaluation evaluated by uroflowmetry between the two prostate enucleation procedures PLASMA and HOLEP at 1-year visit | Uroflowmetry | At 1 year post surgery | |
Secondary | Functional evaluation evaluated by International Prostate Symptom Score between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit | International Prostate Symptom Score | At 3 months post surgery | |
Secondary | Functional evaluation evaluated by International Prostate Symptom Score between the two prostate enucleation procedures PLASMA and HOLEP at 1-year visit | International Prostate Symptom Score | At 1 year post surgery | |
Secondary | Intervention surgery's time between the two prostate enucleation procedures PLASMA and HOLEP | Intervention time (minutes) | through the surgery | |
Secondary | Hospitalisation time between the two prostate enucleation procedures PLASMA and HOLEP | Hospitalisation time (days) | through the hospital stay | |
Secondary | Duration of urinary catheterisation between the two prostate enucleation procedures PLASMA and HOLEP | Duration of urinary catheterisation (minutes) | through the surgery | |
Secondary | Quality of life evaluated by International Prostate Symptom Score between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit | International Prostate Symptom Score - Quality of life dimension | At 3 months post surgery | |
Secondary | Quality of life evaluated by International Prostate Symptom Score between the two prostate enucleation procedures PLASMA and HOLEP at 1-year visit | International Prostate Symptom Score - Quality of life dimension | At 1 year post surgery | |
Secondary | Prescription rate of anti-cholinergic treatment between the two prostate enucleation procedures PLASMA and HOLEP | Recording of prescriptions for anti-cholinergic treatments | through study completion, an average of 1 year | |
Secondary | Rate of re-hospitalization between the two prostate enucleation procedures PLASMA and HOLEP | Record of re-hospitalizations for hematuria with bladder clotting | through study completion, an average of 1 year | |
Secondary | occurrence of short-term surgical complications (within first 3 months) between the two prostate enucleation procedures PLASMA and HOLEP | Collection of acute urine retention, falls, bedsores, urinary tract infections, urinary incontinence | Within the first 3 months | |
Secondary | occurrence of long-term surgical complications (within first 1 year) between the two prostate enucleation procedures PLASMA and HOLEP | Collection of urethral stenosis | through study completion, an average of 1 year | |
Secondary | Safety evaluation between the two prostate enucleation procedures PLASMA and HOLEP | Record of adverse event | through study completion, an average of 1 year |
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