Clinical trial NCT05157724: Observational Study to Compare Two Prostate Laser Enucleation Techniques in Terms of Urinary Incontinence
Official 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostatic Hyperplasia, Benign
Prostatic Adenoma
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients included in this study will be allocated into 2 groups, a PLASMA arm and a HOLEP arm, depending on the technique used by each of the surgeons in the study, which depends on the technology available in the health care institution. Therefore, no randomisation is possible for this study. A balance of centres between those performing the PLASMA technique and those performing the HOLEP technique is set up (2 centres for each technology) in order to allow the inclusion of a comparable number of patients in each group.

Recruitment will take place through the urology consultation flow or through inpatient referrals. In the latter case, patients must have been seen at least once in consultation by an investigating physician prior to the intervention to introduce them to the study.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall urinary incontinence (including stress urinary incontinence and urgency) between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit
timeFrame: At 3 months post surgery
Secondary outcomes:
measure: Overall urinary incontinence (including stress urinary incontinence and urgency) between the two prostate enucleation procedures PLASMA and HOLEP at 1 year visit
timeFrame: At 1 year post surgery
measure: Urinary incontinence evaluated by urinary symptom profile questionnaire between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit
timeFrame: At 3 months post surgery
measure: Urinary incontinence evaluated by urinary symptom profile questionnaire between the two prostate enucleation procedures PLASMA and HOLEP at 1-year visit
timeFrame: At 1 year post surgery
measure: Functional evaluation evaluated by uroflowmetry between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit
timeFrame: At 3 months post surgery
measure: Functional evaluation evaluated by uroflowmetry between the two prostate enucleation procedures PLASMA and HOLEP at 1-year visit
timeFrame: At 1 year post surgery
measure: Functional evaluation evaluated by International Prostate Symptom Score between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit
timeFrame: At 3 months post surgery
measure: Functional evaluation evaluated by International Prostate Symptom Score between the two prostate enucleation procedures PLASMA and HOLEP at 1-year visit
timeFrame: At 1 year post surgery
measure: Intervention surgery's time between the two prostate enucleation procedures PLASMA and HOLEP
timeFrame: through the surgery
measure: Hospitalisation time between the two prostate enucleation procedures PLASMA and HOLEP
timeFrame: through the hospital stay
measure: Duration of urinary catheterisation between the two prostate enucleation procedures PLASMA and HOLEP
timeFrame: through the surgery
measure: Quality of life evaluated by International Prostate Symptom Score between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit
timeFrame: At 3 months post surgery
measure: Quality of life evaluated by International Prostate Symptom Score between the two prostate enucleation procedures PLASMA and HOLEP at 1-year visit
timeFrame: At 1 year post surgery
measure: Prescription rate of anti-cholinergic treatment between the two prostate enucleation procedures PLASMA and HOLEP
timeFrame: through study completion, an average of 1 year
measure: Rate of re-hospitalization between the two prostate enucleation procedures PLASMA and HOLEP
timeFrame: through study completion, an average of 1 year
measure: occurrence of short-term surgical complications (within first 3 months) between the two prostate enucleation procedures PLASMA and HOLEP
timeFrame: Within the first 3 months
measure: occurrence of long-term surgical complications (within first 1 year) between the two prostate enucleation procedures PLASMA and HOLEP
timeFrame: through study completion, an average of 1 year
measure: Safety evaluation between the two prostate enucleation procedures PLASMA and HOLEP
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: ELSAN Pôle Santé République - Urology
Study officials:
affiliation: ELSAN Pôle Santé République - Urology
name: Soria Jérémie, MD
role: PRINCIPAL_INVESTIGATOR
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