Observational Study to Compare Two Prostate Laser Enucleation Techniques in Terms of Urinary Incontinence

Study Overview
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Brief Summary
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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.

Detailed Description
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Benign prostatic hyperplasia or prostatic adenoma is a benign tumour that develops in the central part of the prostate. It usually affects men over the age of 50, with the incidence of the disease increasing with age. Prostatic adenoma may result in the progressive appearance of bladder weakness or frequent urination and other complications (lithiasis, haematuria, urine retention, etc.). Surgery is indicated when medical treatment is no longer effective and in the case of complications. Among the surgical interventions, several techniques are currently offered to the patient: transurethral monopolar resection transvesical adenomectomy HOLEP laser enucleation of the prostate Bipolar resection and enucleation using the Bipolar Plasma Enucleation of the Prostate (BTUEP) technique, also known as PLASMA. Transurethral monopolar resection is considered an obsolete technique by the learned societies, in particular because of the risk of transurethral resection of the prostate syndrom (vital risk for the patient in the event of reabsorption of the peroperative glycocoll washing liquid), the per and postoperative haemorrhagic risk, especially in patients who are on anticoagulants and/or anti-aggregants and who cannot be stopped for the prostatic procedure. Transvesical adenomectomy has a higher bleeding risk due to the fact that it is performed in open surgery, which is much more invasive. There is a transfusion rate of 7-14%. The rate of urinary incontinence can be as high as 10% and the rate of urethral stenosis 6%. Compared to BTUEP or HOLEP, HOLEP has a longer operating time, longer catheterisation and hospitalisation time and a higher transfusion rate for transvesical adenomectomy. Adenomectomy should therefore only be offered if the centre has neither HOLEP nor BTUEP according to European recommendations. The new 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 with the other techniques described above, and the reduced hospitalisation rate. For prostate volumes less than 80cc, there is no difference between HOLEP and BTUEP in terms of IPSS, Qmax, and reoperation rate at 12 months. Compared to conventional transurethral resection of the prostate, there was a significant improvement in International Prostate Symptom Score (IPSS), quality of life (QoL), and Qmax for the BTUEP technique. These results are valid at 36, 48 and 60 months. BTUEP was also superior in terms of haemoglobin loss, duration of irrigation, duration of catheterisation and duration of hospitalisation, as well as a reduction in the post-operative retention rate and the transfusion rate. There is no greater risk of incontinence with BTUEP than with transurethral resection of the prostate. For HOLEP, there was no significant difference in Qmax or reoperation rate compared to MTURP. Compared to BTUEP, there was no significant difference in IPSS, QOL, and Qmax according to two meta-analyses. Functional outcomes at 7 years follow-up between HOLEP and monopolar transurethral resection of the prostate (MTURP) are comparable and HOLEP has an advantage in catheterisation time, hospitalisation, loss of haemoglobin, no more urethral strictures or urge incontinence.The experience of the surgeon is the most important factor influencing the risk of complications in 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. In a comparative study of HOLEP and PLASMA, 19% of incontinence was found at 3 months for HOLEP against 6% for PLASMA. Other a study found lower rates of 5.7% for HOLEP. Based on these data, the functional outcomes of PLASMA and HOLEP are comparable. However, comparative evaluation of the two techniques is less frequent in studies which are generally retrospective or monocentric, hence the interest of our prospective and multicentric study. By comparing two reference techniques of prostatic enucleation, HOLEP and PLASMA, the investigators hope to demonstrate in this study a better result of the PLASMA technique in terms of post-operative residual urinary incontinence. If this is demonstrated, PLASMA could overtake HOLEP, with a significantly lower material cost and a reduced learning curve.

Official Title
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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

Conditions
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Prostatic Hyperplasia, Benign, Prostatic Adenoma

Intervention / Treatment
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* Procedure: PLASMA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PLASMA<br>This technique consists of an endoscopic intervention, through the natural route (urethra). | Procedure: PLASMA<br>* The aim is to remove the prostatic adenoma by enucleation, i.e. to pass through the plane between the adenoma and the prostatic capsule, as opposed to resection, which also consists of removing the adenoma, but by making small cuts in the prostatic tissue, without necessarily reaching this anatomical plane between the adenoma and the capsule. This means removing less adenoma and therefore increasing the risk of adenomatous regrowth in the long term or obtaining worse results than enucleation in the short to medium term. The other advantage of using this approach is that it reduces intra- and post-operative bleeding and does not require the systematic discontinuation of anti-aggregating or anticoagulant treatments prior to the operation. The field of indications is thus potentially enlarged.<br>|
| HOLEP<br>This is a recent and difficult technique of endoscopic prostate enucleation, requiring a greater learning curve for the operators compared to PLASMA. The principle remains the same technically as the PLASMA procedure, the energy used is not electrical energy, but a laser. Once the adenoma has been enucleated, it can only be removed by a morcellator (additional material) which can lead to complications such as bladder perforation. This is a blade that rotates in a tube that has to cut the adenoma once it has been freed from the prostate when it is in the bladder and it can happen that this blade catches on the bladder wall and causes a bladder wound or even a perforation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Functional evaluation evaluated by uroflowmetry between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit | Uroflowmetry | At 3 months post surgery | 
| Functional evaluation evaluated by uroflowmetry between the two prostate enucleation procedures PLASMA and HOLEP at 1-year visit | Uroflowmetry | At 1 year post surgery | 
| 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 | 
| 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 | 
| Intervention surgery's time between the two prostate enucleation procedures PLASMA and HOLEP | Intervention time (minutes) | through the surgery | 
| Hospitalisation time between the two prostate enucleation procedures PLASMA and HOLEP | Hospitalisation time (days) | through the hospital stay | 
| Duration of urinary catheterisation between the two prostate enucleation procedures PLASMA and HOLEP | Duration of urinary catheterisation (minutes) | through the surgery | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Safety evaluation between the two prostate enucleation procedures PLASMA and HOLEP | Record of adverse event | through study completion, an average of 1 year |