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

NCT05157724 | Withdrawn

• 1 other identifier: ENUPLASMHO
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Hyperplasia, Benign; Prostatic Adenoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Overall urinary incontinence (including stress urinary incontinence and urgency) between the two prostate enucleation procedures PLASMA and HOLEP at 1 year visit

  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

  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

  At 1 year post surgery

• Functional evaluation evaluated by uroflowmetry between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit

  At 3 months post surgery

• Functional evaluation evaluated by uroflowmetry between the two prostate enucleation procedures PLASMA and HOLEP at 1-year visit

  At 1 year post surgery

Study Arms (2)

PLASMA

This technique consists of an endoscopic intervention, through the natural route (urethra).

Procedure: PLASMA

HOLEP

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.

Interventions

PLASMA PROCEDURE

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.

PLASMA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patient with a diagnosis of prostate cancer,
• Patient requiring monopolar or bipolar endoscopic resection,
• Patient under legal protection

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

ELSAN Pôle Santé République - Urology

Clermont-Ferrand, 63050, France

Location

Related Publications (26)

• Professionals S-O. EAU Guidelines: Management of Non-neurogenic Male LUTS

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MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Soria Jérémie, MD

  ELSAN Pôle Santé République - Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 15, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2024
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

FR (1)