Lower Urinary Tract Symptoms Clinical Trial
Official title:
Endoscopic Enucleation of the Prostate in Patients With Urodynamically Proven Detrusor Underactivity/Acontractility
The aim of this project is to create und evaluate a multicentral, retro-/prospective database for patients with urodynamically proven detrusor underactivity (DU) or acontractility (DA) secondary to a non-neurogenic aetiology, who undergo endoscopic, anatomic enucleation of the prostate (EEP).
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | September 2028 |
Est. primary completion date | September 2027 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Endoscopic enucleation of the prostate in patients with DU/DA secondary to a non-neurogenic aetiology: - Detrusor underactivity (DU) defined urodynamically as a bladder contractility index (BCI) of <100. - Detrusor acontractility (DA) defined urodynamically as the absence of a detrusor contraction despite filling to bladder capacity. Exclusion Criteria: - Neurogenic aetiology for DU/DA (Parkinson, stroke…) - Other surgical approaches for the treatment of benign prostate hyperplasia (Aquaablation, open enucleation of the prostate, open prostatectomy, transurethral resection of the prostate...) |
Country | Name | City | State |
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Lead Sponsor | Collaborator |
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EEPiDuDa Study Group |
Aho T, Finch W, Jefferson P, Suraparaju L, Georgiades F. HoLEP for acute and non-neurogenic chronic urinary retention: how effective is it? World J Urol. 2021 Jul;39(7):2355-2361. doi: 10.1007/s00345-021-03657-x. Epub 2021 Mar 24. — View Citation
Cho MC, Yoo S, Park J, Cho SY, Son H, Oh SJ, Paick JS. Effect of preoperative detrusor underactivity on long-term surgical outcomes of photovaporization and holmium laser enucleation in men with benign prostatic hyperplasia: a lesson from 5-year serial follow-up data. BJU Int. 2019 May;123(5A):E34-E42. doi: 10.1111/bju.14661. Epub 2019 Jan 27. — View Citation
Gomez-Sancha F. The constant search for the greater good: evolving from TURP to anatomic enucleation of the prostate is a safe bet. World J Urol. 2021 Jul;39(7):2401-2406. doi: 10.1007/s00345-021-03637-1. Epub 2021 Feb 24. — View Citation
Herrmann TR, Bach T, Imkamp F, Georgiou A, Burchardt M, Oelke M, Gross AJ. Thulium laser enucleation of the prostate (ThuLEP): transurethral anatomical prostatectomy with laser support. Introduction of a novel technique for the treatment of benign prostatic obstruction. World J Urol. 2010 Feb;28(1):45-51. doi: 10.1007/s00345-009-0503-0. — View Citation
Herrmann TR. Enucleation is enucleation is enucleation is enucleation. World J Urol. 2016 Oct;34(10):1353-5. doi: 10.1007/s00345-016-1922-3. Epub 2016 Sep 1. — View Citation
Herrmann TRW, Wolters M. Transurethral anatomical enucleation of the prostate with Tm:YAG support (ThuLEP): Evolution and variations of the technique. The inventors' perspective. Andrologia. 2020 Sep;52(8):e13587. doi: 10.1111/and.13587. Epub 2020 Apr 14. — View Citation
Miernik A, Roehrborn CG. Benign Prostatic Hyperplasia Treatment On Its Way to Precision Medicine: Dream or Reality? Eur Urol Focus. 2022 Mar;8(2):363-364. doi: 10.1016/j.euf.2022.03.023. Epub 2022 Apr 7. No abstract available. — View Citation
Mitchell CR, Mynderse LA, Lightner DJ, Husmann DA, Krambeck AE. Efficacy of holmium laser enucleation of the prostate in patients with non-neurogenic impaired bladder contractility: results of a prospective trial. Urology. 2014 Feb;83(2):428-32. doi: 10.1016/j.urology.2013.09.035. Epub 2013 Nov 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Residual volume | Determined by sonography (ml) | 2 months after surgery | |
Primary | Residual volume | Determined by sonography (ml) | 1 year after surgery | |
Primary | International Prostate Symptom Score (IPSS) | Determined with a validated IPSS questionnaire (in the corresponding language) | 2 months after surgery | |
Primary | International Prostate Symptom Score (IPSS) | Determined with a validated IPSS questionnaire (in the corresponding language) | 1 year after surgery | |
Primary | Quality of life | Determined with a validated QoL questionnaire (in the corresponding language) | 2 months after surgery | |
Primary | Quality of life | Determined with a validated QoL questionnaire (in the corresponding language) | 1 year after surgery | |
Primary | Maximal flow rate (Qmax) | Determined using uroflowmetry (ml/s) | 2 months after surgery | |
Primary | Maximal flow rate (Qmax) | Determined using uroflowmetry (ml/s) | 1 year after surgery | |
Primary | Voided volume (VV) | Determined using uroflowmetry (ml) | 2 months after surgery | |
Primary | Voided volume (VV) | Determined using uroflowmetry (ml) | 1 year after surgery | |
Primary | Catheter - free rate | Is the patient still having an indwelling or suprapubic catheter? | 2 months after surgery | |
Primary | Catheter - free rate | Is the patient still having an indwelling or suprapubic catheter? | 1 year after surgery |
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