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

Studies

Study First Submitted Date 2021-11-19
Study First Posted Date 2021-12-15
Last Update Posted Date 2023-06-18
Start Month Year October 2023
Primary Completion Month Year November 2024
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-06-18

Detailed Descriptions

Sequence: 20651727
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.

Facilities

Sequence: 199341817
Name ELSAN Pôle Santé République – Urology
City Clermont-Ferrand
Zip 63050
Country France

Conditions

Sequence: 51990097 Sequence: 51990098
Name Prostatic Hyperplasia, Benign Name Prostatic Adenoma
Downcase Name prostatic hyperplasia, benign Downcase Name prostatic adenoma

Id Information

Sequence: 40017488
Id Source org_study_id
Id Value ENUPLASMHO

Countries

Sequence: 42412310
Name France
Removed False

Design Groups

Sequence: 55393179 Sequence: 55393180
Title PLASMA Title HOLEP
Description This technique consists of an endoscopic intervention, through the natural route (urethra). Description 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

Sequence: 52301848
Intervention Type Procedure
Name PLASMA
Description 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.

Design Outcomes

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Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Overall urinary incontinence (including stress urinary incontinence and urgency) between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit Measure Overall urinary incontinence (including stress urinary incontinence and urgency) between the two prostate enucleation procedures PLASMA and HOLEP at 1 year visit Measure Urinary incontinence evaluated by urinary symptom profile questionnaire between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit Measure Urinary incontinence evaluated by urinary symptom profile questionnaire between the two prostate enucleation procedures PLASMA and HOLEP at 1-year visit Measure Functional evaluation evaluated by uroflowmetry between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit Measure Functional evaluation evaluated by uroflowmetry between the two prostate enucleation procedures PLASMA and HOLEP at 1-year visit Measure Functional evaluation evaluated by International Prostate Symptom Score between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit Measure Functional evaluation evaluated by International Prostate Symptom Score between the two prostate enucleation procedures PLASMA and HOLEP at 1-year visit Measure Intervention surgery's time between the two prostate enucleation procedures PLASMA and HOLEP Measure Hospitalisation time between the two prostate enucleation procedures PLASMA and HOLEP Measure Duration of urinary catheterisation between the two prostate enucleation procedures PLASMA and HOLEP Measure Quality of life evaluated by International Prostate Symptom Score between the two prostate enucleation procedures PLASMA and HOLEP at 3-month visit Measure Quality of life evaluated by International Prostate Symptom Score between the two prostate enucleation procedures PLASMA and HOLEP at 1-year visit Measure Prescription rate of anti-cholinergic treatment between the two prostate enucleation procedures PLASMA and HOLEP Measure Rate of re-hospitalization between the two prostate enucleation procedures PLASMA and HOLEP Measure occurrence of short-term surgical complications (within first 3 months) between the two prostate enucleation procedures PLASMA and HOLEP Measure occurrence of long-term surgical complications (within first 1 year) between the two prostate enucleation procedures PLASMA and HOLEP Measure Safety evaluation between the two prostate enucleation procedures PLASMA and HOLEP
Time Frame At 3 months post surgery Time Frame At 1 year post surgery Time Frame At 3 months post surgery Time Frame At 1 year post surgery Time Frame At 3 months post surgery Time Frame At 1 year post surgery Time Frame At 3 months post surgery Time Frame At 1 year post surgery Time Frame through the surgery Time Frame through the hospital stay Time Frame through the surgery Time Frame At 3 months post surgery Time Frame At 1 year post surgery Time Frame through study completion, an average of 1 year Time Frame through study completion, an average of 1 year Time Frame Within the first 3 months Time Frame through study completion, an average of 1 year Time Frame through study completion, an average of 1 year
Description Pad weight testing during 3 consecutive days Description Pad weight testing during 3 consecutive days Description Urinary symptom profile questionnaire Description Urinary symptom profile questionnaire Description Uroflowmetry Description Uroflowmetry Description International Prostate Symptom Score Description International Prostate Symptom Score Description Intervention time (minutes) Description Hospitalisation time (days) Description Duration of urinary catheterisation (minutes) Description International Prostate Symptom Score – Quality of life dimension Description International Prostate Symptom Score – Quality of life dimension Description Recording of prescriptions for anti-cholinergic treatments Description Record of re-hospitalizations for hematuria with bladder clotting Description Collection of acute urine retention, falls, bedsores, urinary tract infections, urinary incontinence Description Collection of urethral stenosis Description Record of adverse event

Browse Conditions

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Mesh Term Adenoma Mesh Term Urinary Incontinence Mesh Term Enuresis Mesh Term Prostatic Hyperplasia Mesh Term Hyperplasia Mesh Term Urination Disorders Mesh Term Urologic Diseases Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Male Urogenital Diseases Mesh Term Lower Urinary Tract Symptoms Mesh Term Urological Manifestations Mesh Term Behavioral Symptoms Mesh Term Elimination Disorders Mesh Term Mental Disorders Mesh Term Pathologic Processes Mesh Term Neoplasms, Glandular and Epithelial Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Prostatic Diseases Mesh Term Genital Diseases, Male Mesh Term Genital Diseases
Downcase Mesh Term adenoma Downcase Mesh Term urinary incontinence Downcase Mesh Term enuresis Downcase Mesh Term prostatic hyperplasia Downcase Mesh Term hyperplasia Downcase Mesh Term urination disorders Downcase Mesh Term urologic diseases Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term male urogenital diseases Downcase Mesh Term lower urinary tract symptoms Downcase Mesh Term urological manifestations Downcase Mesh Term behavioral symptoms Downcase Mesh Term elimination disorders Downcase Mesh Term mental disorders Downcase Mesh Term pathologic processes Downcase Mesh Term neoplasms, glandular and epithelial Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term prostatic diseases Downcase Mesh Term genital diseases, male Downcase Mesh Term genital diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48149532
Agency Class OTHER
Lead Or Collaborator lead
Name Elsan

Overall Officials

Sequence: 29181145
Role Principal Investigator
Name Soria Jérémie, MD
Affiliation ELSAN Pôle Santé République – Urology

Central Contacts

Sequence: 11968374
Contact Type primary
Name Soria Jérémie, MD
Phone (0)4 73 99 49 22
Email soria.psr@gmail.com
Phone Extension +33
Role Contact

Design Group Interventions

Sequence: 67906054
Design Group Id 55393179
Intervention Id 52301848

Eligibilities

Sequence: 30658922
Sampling Method Non-Probability Sample
Gender Male
Minimum Age 18 Years
Maximum Age 80 Years
Healthy Volunteers No
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.
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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254270350
Number Of Facilities 1
Registered In Calendar Year 2021
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 80
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 17

Designs

Sequence: 30405750
Observational Model Cohort
Time Perspective Prospective

Responsible Parties

Sequence: 28772276
Responsible Party Type Sponsor

Study References

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Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Professionals S-O. EAU Guidelines: Management of Non-neurogenic Male LUTS Citation Varkarakis I, Kyriakakis Z, Delis A, Protogerou V, Deliveliotis C. Long-term results of open transvesical prostatectomy from a contemporary series of patients. Urology. 2004 Aug;64(2):306-10. doi: 10.1016/j.urology.2004.03.033. Citation 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. 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. 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. 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. 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. Citation Tubaro A, Carter S, Hind A, Vicentini C, Miano L. A prospective study of the safety and efficacy of suprapubic transvesical prostatectomy in patients with benign prostatic hyperplasia. J Urol. 2001 Jul;166(1):172-6. 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. 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. 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. 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. Citation Zhu L, Chen S, Yang S, Wu M, Ge R, Wu W, Liao L, Tan J. Electrosurgical enucleation versus bipolar transurethral resection for prostates larger than 70 ml: a prospective, randomized trial with 5-year followup. J Urol. 2013 Apr;189(4):1427-31. doi: 10.1016/j.juro.2012.10.117. Epub 2012 Oct 31. Erratum In: J Urol. 2013 Jun;189(6):2396. 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. 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. Citation 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. Citation Gilling PJ, Wilson LC, King CJ, Westenberg AM, Frampton CM, Fraundorfer MR. 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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. Citation Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25. Citation 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. Citation Du C, Jin X, Bai F, Qiu Y. Holmium laser enucleation of the prostate: the safety, efficacy, and learning experience in China. J Endourol. 2008 May;22(5):1031-6. doi: 10.1089/end.2007.0262. Citation Houssin V, Olivier J, Brenier M, Pierache A, Laniado M, Mouton M, Theveniaud PE, Baumert H, Mallet R, Marquette T, Villers A, Robert G, Rizk J. Predictive factors of urinary incontinence after holmium laser enucleation of the prostate: a multicentric evaluation. World J Urol. 2021 Jan;39(1):143-148. doi: 10.1007/s00345-020-03169-0. Epub 2020 Mar 26. 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 Citation Fallara G, Capogrosso P, Schifano N, Costa A, Candela L, Cazzaniga W, Boeri L, Belladelli F, Scattoni V, Salonia A, Montorsi F. Ten-year Follow-up Results After Holmium Laser Enucleation of the Prostate. Eur Urol Focus. 2021 May;7(3):612-617. doi: 10.1016/j.euf.2020.05.012. Epub 2020 Jun 21.