Association of Urine BDNF and NGF With Lower Urinary System Parameters

NCT06265519 | Recruiting

• 1 other identifier: MAR.UAD.008
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Histologically, BPH is a benign proliferative process involving both epithelial and stromal elements and is characterised by progressive enlargement of the prostate. Symptom complex including increased frequency of urination, sudden feeling of urge to urinate, nocturia, difficulty in urinating, feeling of incomplete emptying of the bladder, decreased flow rate and intermittent urination are called lower urinary tract symptoms (LUTS). The most important cause of LUTS in men is BPH. Many structural and physiological changes occur in the lower urinary system with bladder outlet obstruction. Detrusor hypertrophy and bladder hyperactivity may occur due to bladder outlet obstruction. Although the density of afferent and efferent nerves in the bladder decreases after urethral obstruction, enlargement of their trunks indicates that changes occur in these nerves. In addition, changes also occur in the neural pathways of the central nervous system following lower urinary tract obstruction. Nerve growth factor (NGF) and brain derived neurotropin factor (BDNF) are trophic proteins that act as retrograde messengers between peripheral effector tissue and the nerves that innervate it. In peripheral tissues, the source of NGF and BDNF is presumed to be the target tissues innervated by nerves. Smooth muscle cells, fibroblasts, astrocytes and other cells synthesise NGF and BDNF in culture medium. Many potential stimuli that increase NGF in the lower urinary system have been identified. These are denervation, inflammation and mechanical tension. This information has led to the idea that autonomic innervation changes in the bladder may be related with changing NGF levels. Altered afferent and adrenergic innervation in the obstructed bladder increases the possibility that NGF plays an important role in this neural growth because this type of nerves are highly sensitive to this neurotrophin. In this study, we investigated NGF ve BDNF levels in urine samples obtained before surgery (Transurethral Prostate Resection, Prostate Enucleation with Holmium Laser and Prostate Enucleation with Thulium Fibre Laser) and after removal of obstruction in patients with bladder outlet obstruction secondary to benign prostatic enlargement using ELISA method, We aimed to determine the role of NGF and BDNF in bladder outlet obstruction and bladder changes secondary to obstruction by comparing with control patients without obstruction.

Conditions

Benign Prostatic Hyperplasia With Outflow Obstruction; Lower Urinary Tract Obstructive Syndrome

Outcome Measures

Primary Outcomes (1)

• Uroflowmetry

  Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.

  1 year

Secondary Outcomes (1)

• International prostate symptom score

  1 year

Other Outcomes (1)

• Urodynamic

  Before surgery

Study Arms (3)

Patients before surgery

ACTIVE COMPARATOR

Men between the ages of 50 and 80 diagnosed with BPH before surgery

Procedure: Holmium laser enucleation of the prostate

Patients after surgery

ACTIVE COMPARATOR

Men between the ages of 50 and 80 diagnosed with BPH after surgery

Procedure: Holmium laser enucleation of the prostate

Healthy

NO INTERVENTION

Men between the ages of 50-80 years without lower urinary tract disease

Interventions

Holmium laser enucleation of the prostate PROCEDURE

Holmium laser enucleation of the prostate is a minimally invasive procedure that uses pulses of laser beam to remove tissue from the inside of the prostate, which surrounds the urethra (the tube leading from the bladder to the urinary opening) in patients with BPH

Patients after surgery; Patients before surgery

Eligibility Criteria

• Age: 50 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years Male
• Patients with bladder outlet obstruction secondary to benign prostate hyperplasia

You may not qualify if:

• Known neurological disease
• Diabetes
• Urinary tract infection
• Previous prostate surgery
• Spinal Cord Trauma
• Bladder stone 8-Cerebrovascular disease 9-Chronic Renal Failure 10-Ureteral stenosis

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

• Tufan Tarcan, Prof. Dr.

  Marmara University

  STUDY DIRECTOR

• Çağrı Akın Şekerci, Assoc. Prof.

  Marmara University

  STUDY DIRECTOR

• Banu İşbilen Başok, Prof. Dr.

  Dr. Behçet Uz Children's Hospital

  STUDY DIRECTOR

• Kader Ada Doğan, MD

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Haydar Kamil ÇAM, Prof. Dr.

CONTACT

+905323259547; kamilcam@hotmail.com

Kader Ada Doğan, MD

CONTACT

+905323845598; kader.dogan11@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 0
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 20, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)