Prostatic Hyperplasia Clinical Trial
Official title:
Laser Vaporization of the Prostate: Comparative Study Between Ejaculatory Preserving and Non-ejaculatory Preserving Technique
The present work aimed to compare between The Outcomes of conventional technique of laser prostatectomy versus the new ejaculatory sparing technique .
Benign prostate hyperplasia (BPH) is a histological diagnosis which is identified by non-malignant hyperplasia of prostatic tissue due to smooth muscle and epithelial cell proliferation in the prostate transition zone. The prevalence of histologically diagnosed (BPH) increases from 8% in men aged 31 to 40 years old to 40-50% in men aged 51 to 60 years old. This increases to over 80% in men older than 80 years old. Bladder outlet obstructions (BOO) are one of the major disorders in the aging male, The most common aetiology of BOO in elderly men above the age of 60 years is (BPH), but younger men (< 50 years old) can also experience infra vesical obstruction from a small but obstructive prostate. Ejaculation is one of the fundamental domains of male sexual function An almost inevitable adverse event of the conventional TURP is the loss of antegrade ejaculation, seen in 65%-80% of patients. The use of alpha receptor antagonists is also known to cause a loss in antegrade ejaculation. Aside from peri- and postoperative morbidities, such as bleeding and TURP syndrome, the loss of ejaculation represents a major reason for the avoidance of surgical treatment. This is a particular issue among young people who hesitate to agree to the TURP procedure due to the fear of loss of ejaculation. Losing the ability to ejaculate often leads to a subsequent decrease in sexual pleasure, which has psychosocial implications but can also impact on aspects related to their cultural background, desire for children, and sexual life. According to the current theory of ejaculation, the loss of antegrade ejaculation is attributed to the loss of bladder neck function after resection. Even though TURP has a high success rate, the perioperative morbidity and operative safety specially in relation to bleeding pose serious concerns In addition to bleeding, retrograde ejaculation and TURP syndrome due to irrigant absorption are also relevant to intra and postoperative complications. Despite technical advancements in TURP, blood transfusion rates are still 2 % to 7 %, TUR syndrome occurs in 2 %, stress urinary incontinence in 2 %, retrograde ejaculation in 65 % to 70.0%, urethral strictures in 4 %, bladder neck contractures in 4 % and early revision rates are 3 % to 5 %. These, along with prolonged catheterization time, advocate for alternatives to this treatment modality that offer similar clinical results but fewer complications Laser vaporization of prostate is one of these methods. Lasers generate different effects in tissues, like coagulation and vaporization. Different types of laser like potassium-titanyl phosphate (KTP), holmium, diode and thulium are available. Of these, those gaining more popularity are the photoselective vaporization of the prostate (PVP) using the KTP laser, and holmium laser enucleation of the prostate (HOLEP). The semiconductor diode laser is thought to be the best in relation to its haemostatic properties, but due to postoperative dysuria, pain, and storage urinary symptoms, it was less acceptable , A newly introduced diode laser, operating on the wavelength of 980 nm, is different in terms of its new fiber design, greater ablative properties of tissues, and efficient haemostasis due to its significant simultaneous absorption in water and Haemoglobin The conventional technique of laser prostatectomy is traditionally performed with careful vaporization of apical tissue around the verumontanum. To preserve the antegrade ejaculation, the paracollicular and the situated tissue, which is located 1 cm proximal to the verumontanum should not be vaporized. This is mainly related to the importance of the musculus ejaculatorius and verumontanum for ejaculation. Based on this clearer understanding of the process of ejaculation, a new technique of trans urethral laser vaporization of the prostate , termed ejaculation-preserving technique was developed with the overarching aim of preserving antegrade ejaculation with comparable functional outcome for micturition parameters to regular technique. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02578953 -
Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects
|
Phase 1 | |
Terminated |
NCT02396420 -
Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams
|
Phase 2 | |
Terminated |
NCT04398966 -
Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia
|
N/A | |
Not yet recruiting |
NCT06452927 -
EEP in Patients With Urodynamically Proven DU/DA
|
N/A | |
Completed |
NCT02947958 -
Teleconsultation in Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia
|
N/A | |
Completed |
NCT01937871 -
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
|
Phase 3 | |
Completed |
NCT00427882 -
Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study
|
Phase 4 | |
Completed |
NCT02244320 -
Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)
|
N/A | |
Completed |
NCT01254071 -
A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry.
|
Phase 1 | |
Recruiting |
NCT04108871 -
Whether Transperineal Prostate Biopsy Under Local-anaesthesia Using a Transperineal-access System is Non-inferior to Standard Transrectal Biopsy to Detect Prostate Cancer in Biopsy-naïve Men
|
N/A | |
Recruiting |
NCT05686525 -
Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men With BPH
|
N/A | |
Completed |
NCT01957189 -
This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples
|
Phase 1 | |
Completed |
NCT00316732 -
Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS
|
N/A | |
Completed |
NCT02715401 -
PK and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 Under Fed Condition in Healthy Male Volunteers
|
Phase 1 | |
Recruiting |
NCT02278679 -
Digital Rectal Exam Proficiency Tool
|
N/A | |
Completed |
NCT01482676 -
The Role of microRNAs in Organ Remodeling in Lower Urinary Tract Dysfunction
|
N/A | |
Completed |
NCT01376258 -
Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database
|
N/A | |
Completed |
NCT00822952 -
Prostate Mechanical Imager (PMI) Clinical Bridging Study
|
N/A | |
Completed |
NCT00527605 -
Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)
|
Phase 3 | |
Terminated |
NCT00563654 -
Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up
|
N/A |