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

Prostatic Hyperplasia, Benign Clinical Trial

— ENUPLASMHO  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05157724
• Other study ID #: ENUPLASMHO
• Status: Withdrawn
• Start date: November 2021
• Est. completion date: November 2026

Study information

• Verified date: February 2024
• Source: Elsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adenoma
• Enuresis
• Hyperplasia
• Prostatic Adenoma
• Prostatic Hyperplasia
• Prostatic Hyperplasia, Benign
• Urinary Incontinence

Intervention

Procedure:
• PLASMA
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.

Locations

Country	Name	City	State
France	ELSAN Pôle Santé République - Urology	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

References & Publications (26)

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Elzayat EA, Elhilali MM. Holmium laser enucleation of the prostate (HoLEP): long-term results, reoperation rate, and possible impact of the learning curve. Eur Urol. 2007 Nov;52(5):1465-71. doi: 10.1016/j.eururo.2007.04.074. Epub 2007 May 4. — View Citation

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Gilling PJ, Wilson LC, King CJ, Westenberg AM, Frampton CM, Fraundorfer MR. Long-term results of a randomized trial comparing holmium laser enucleation of the prostate and transurethral resection of the prostate: results at 7 years. BJU Int. 2012 Feb;109(3):408-11. doi: 10.1111/j.1464-410X.2011.10359.x. Epub 2011 Aug 23. — View Citation

Gratzke C, Schlenker B, Seitz M, Karl A, Hermanek P, Lack N, Stief CG, Reich O. Complications and early postoperative outcome after open prostatectomy in patients with benign prostatic enlargement: results of a prospective multicenter study. J Urol. 2007 Apr;177(4):1419-22. doi: 10.1016/j.juro.2006.11.062. — View Citation

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Kuntz RM, Lehrich K, Ahyai SA. Holmium laser enucleation of the prostate versus open prostatectomy for prostates greater than 100 grams: 5-year follow-up results of a randomised clinical trial. Eur Urol. 2008 Jan;53(1):160-6. doi: 10.1016/j.eururo.2007.08.036. Epub 2007 Aug 28. — View Citation

Li K, Wang D, Hu C, Mao Y, Li M, Si-Tu J, Huang W, Qiu W, Qiu J. A Novel Modification of Transurethral Enucleation and Resection of the Prostate in Patients With Prostate Glands Larger than 80 mL: Surgical Procedures and Clinical Outcomes. Urology. 2018 Mar;113:153-159. doi: 10.1016/j.urology.2017.11.036. Epub 2018 Jan 3. — View Citation

Li M, Qiu J, Hou Q, Wang D, Huang W, Hu C, Li K, Gao X. Endoscopic enucleation versus open prostatectomy for treating large benign prostatic hyperplasia: a meta-analysis of randomized controlled trials. PLoS One. 2015 Mar 31;10(3):e0121265. doi: 10.1371/journal.pone.0121265. eCollection 2015. — View Citation

Lin Y, Wu X, Xu A, Ren R, Zhou X, Wen Y, Zou Y, Gong M, Liu C, Su Z, Herrmann TR. Transurethral enucleation of the prostate versus transvesical open prostatectomy for large benign prostatic hyperplasia: a systematic review and meta-analysis of randomized controlled trials. World J Urol. 2016 Sep;34(9):1207-19. doi: 10.1007/s00345-015-1735-9. Epub 2015 Dec 23. — View Citation

Lourenco T, Pickard R, Vale L, Grant A, Fraser C, MacLennan G, N'Dow J; Benign Prostatic Enlargement team. Alternative approaches to endoscopic ablation for benign enlargement of the prostate: systematic review of randomised controlled trials. BMJ. 2008 Jun 30;337(7660):a449. doi: 10.1136/bmj.39575.517674.BE. — View Citation

Naspro R, Suardi N, Salonia A, Scattoni V, Guazzoni G, Colombo R, Cestari A, Briganti A, Mazzoccoli B, Rigatti P, Montorsi F. Holmium laser enucleation of the prostate versus open prostatectomy for prostates >70 g: 24-month follow-up. Eur Urol. 2006 Sep;50(3):563-8. doi: 10.1016/j.eururo.2006.04.003. Epub 2006 May 2. — View Citation

Neill MG, Gilling PJ, Kennett KM, Frampton CM, Westenberg AM, Fraundorfer MR, Wilson LC. Randomized trial comparing holmium laser enucleation of prostate with plasmakinetic enucleation of prostate for treatment of benign prostatic hyperplasia. Urology. 2006 Nov;68(5):1020-4. doi: 10.1016/j.urology.2006.06.021. Epub 2006 Nov 7. — View Citation

Patard P, Roumiguié M, Beauval JB, Sanson S, Roulette P, Teillac L, et al. Énucléation endoscopique pour hbp obstructive : comparaison holep vs plasma. Étude prospective monocentrique des résultats périopératoires et à 1 an chez 200 patients. Progrès en Urologie. 1 nov 2018;28(13):652

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

Qian X, Liu H, Xu D, Xu L, Huang F, He W, Qi J, Zhu Y, Xu D. Functional outcomes and complications following B-TURP versus HoLEP for the treatment of benign prostatic hyperplasia: a review of the literature and Meta-analysis. Aging Male. 2017 Sep;20(3):184-191. doi: 10.1080/13685538.2017.1295436. Epub 2017 Apr 3. — View Citation

Skolarikos A, Papachristou C, Athanasiadis G, Chalikopoulos D, Deliveliotis C, Alivizatos G. Eighteen-month results of a randomized prospective study comparing transurethral photoselective vaporization with transvesical open enucleation for prostatic adenomas greater than 80 cc. J Endourol. 2008 Oct;22(10):2333-40. doi: 10.1089/end.2008.9709. — View Citation

Tan A, Liao C, Mo Z, Cao Y. Meta-analysis of holmium laser enucleation versus transurethral resection of the prostate for symptomatic prostatic obstruction. Br J Surg. 2007 Oct;94(10):1201-8. doi: 10.1002/bjs.5916. — View Citation

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Yin L, Teng J, Huang CJ, Zhang X, Xu D. Holmium laser enucleation of the prostate versus transurethral resection of the prostate: a systematic review and meta-analysis of randomized controlled trials. J Endourol. 2013 May;27(5):604-11. doi: 10.1089/end.2012.0505. Epub 2013 Feb 1. — View Citation

Zhang X, Shen P, He Q, Yin X, Chen Z, Gui H, Shu K, Tang Q, Yang Y, Pan X, Wang J, Chen N, Zeng H. Different lasers in the treatment of benign prostatic hyperplasia: a network meta-analysis. Sci Rep. 2016 Mar 24;6:23503. doi: 10.1038/srep23503. — View Citation

Zhang Y, Yuan P, Ma D, Gao X, Wei C, Liu Z, Li R, Wang S, Liu J, Liu X. Efficacy and safety of enucleation vs. resection of prostate for treatment of benign prostatic hyperplasia: a meta-analysis of randomized controlled trials. Prostate Cancer Prostatic Dis. 2019 Dec;22(4):493-508. doi: 10.1038/s41391-019-0135-4. Epub 2019 Feb 28. — View Citation

Zhao Z, Zeng G, Zhong W, Mai Z, Zeng S, Tao X. A prospective, randomised trial comparing plasmakinetic enucleation to standard transurethral resection of the prostate for symptomatic benign prostatic hyperplasia: three-year follow-up results. Eur Urol. 2010 Nov;58(5):752-8. doi: 10.1016/j.eururo.2010.08.026. Epub 2010 Aug 20. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

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