Clinical Research Directory

Turkish Version of the Neurogenic Bladder Symptom Score Short Form

This observational study aims to evaluate the cross-cultural adaptation and psychometric properties of the Turkish version of the Neurogenic Bladder Symptom Score Short Form (NBSS-SF) in adults with spinal cord injury or multiple sclerosis who have neurogenic lower urinary tract dysfunction. Neurogenic bladder symptoms, such as urinary incontinence, urgency, and difficulties with urine storage or emptying, may negatively affect daily functioning and quality of life. In this study, the validity and reliability of the Turkish NBSS-SF will be examined, and convergent validity will be assessed through its relationship with the King's Health Questionnaire (KHQ) and the Short Form-12 (SF-12). In eligible participants, the scale will be administered again after 7 to 14 days. The aim of the study is to provide a valid and reliable Turkish patient-reported outcome measure for use in clinical practice and research.

New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia

SRD5A2 is a critical enzyme for prostatic development and growth, and the SRD5A2 inhibitor, finasteride, is used to treat benign prostatic hyperplasia (BPH). SRD5A2 is absent in 30% of normal adult men, which explains the resistance of a subset of patients to this commonly prescribed drug. This project proposes new combination therapies (5-ARI+raloxifene) and evaluates novel non-invasive biomarkers, based on alternative pathways that lead to prostatic enlargement.

Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer (X-SMILE)

The aim of this phase II international multicenter study is to evaluate the safety, feasibility, and efficacy of CT or MRI-adaptive SBRT, delivered in five weekly fractions, in patients with newly diagnosed localized prostate cancer who have lower urinary tract symptoms and/or prostatic hyperplasia.

Intradetrusor Onabotulinumtoxin A (Botox) at the Time of Transurethral Resection of the Prostate or Transurethral Waterjet Ablation of the Prostate for Mixed Lower Urinary Tract Symptoms

Patients with longstanding obstructive lower urinary tract symptoms (LUTS) due to benign prostatic hypertrophy (BPH) can also develop symptoms of overactive bladder syndrome (OAB). Transurethral resection of the prostate (TURP) and Transurethral Waterjet Ablation of the Prostate (Aquablation) are amongst the gold standard surgical treatments for BPH. However, in the immediate post-operative period, TURP and Aquablation can also include OAB-like symptoms, including urinary frequency and urgency. For men with baseline OAB symptoms, this initial worsening of symptoms can be distressing. Botox is an FDA approved medication with on-label indications to treat overactive bladder. The purpose of this study is to evaluate the outcomes of men who have Botox concurrent with their TURP or Aquablation.

Evaluation of the Optilume BPH Catheter System and the Rezum Water Vapor Therapy in Treating Benign Prostatic Hyperplasia

Lower urinary symptoms (LUTS) affect older men and their frequency and severity increase with age. According to Berry et al., the histological diagnosis of benign prostatic hyperplasia (BPH) increases from 25% in the group age between 40 to 49 years to 80% in the group age between 70 to 79 years (1). However, this hyperplasia can lead to a bladder outlet obstruction (BOO) secondary to benign prostatic enlargement (BPE), causing storage and voiding symptoms, associated with a considerable impairment of the quality of life (2). Surgical therapy of BPH has continuously evolved in recent years. The current gold standard for the endoscopic treatment of BPH is the transurethral resection of the prostate (TURP). Other innovative techniques were developed including Urolift, transurethral laser enucleation (holmium, thulium) and Aquablation therapy. One of the latest technologies for the management of BPH are Optilume BPH Catheter System (Optilume®, Urotronic Inc, Minneapolis, USA) and Rezum Water Vapor Therapy (Rezum System, Bostocn Scientific, Marlborough, MA). The purpose of the present study is to compare between patient experience, symptom relief and functional improvement when using the Optilume BPH Catheter System (Optilume®, Urotronic Inc, Minneapolis, USA) and Rezum Water Vapor Therapy (Rezum System, Boston Scientific, Marlborough, MA).

E-Sense® Normal Values of Urodynamic Pressures Using E-Sense® Catheters

In this post-market observational study, subjects referred to urodynamic testing will be approached to enroll in a clinical study to define the normal range of pressure values utilizing e-Sense® catheters. Urodynamic test results using the study devices will be provided back to the study sponsor for test interpretation and to publish. The urodynamic information collected using the study devices will be used in the UDS test interpretation for each subject enrolled, unless there is a reason to believe the test should be repeated (i.e. inconclusive results).

Effects of Lumbopelvic Stabilization-based Physiotherapy and Rehabilitation Training in Duchenne Muscular Dystrophy

This study aims to examine the effectiveness of supervised lumbopelvic stabilization in relation to factors associated with lower urinary tract symptoms in children diagnosed with Duchenne Muscular Dystrophy (DMD) who have lower urinary tract dysfunction. Children aged between 8 and 12 years, at stages 1-4 according to the Vignos scale, and who have a score of 8.5 or higher on the Dysfunctional Voiding Symptom Score (DVSS), will be included in the study. Demographic information will be collected through a general assessment form, while lower urinary tract symptoms will be assessed using the DVSS, a researcher-developed evaluation form, and a three-day bladder diary. Bowel symptoms will be evaluated using the Rome IV criteria and a seven-day bowel diary. Physical performance will be assessed via the Timed Up and Go Test and Gower's Test, muscle strength using the microFET2 hand dynamometer, lumbar lordosis angle with a Bubble inclinometer, participation in daily living activities via the Barthel Index, and perceived well-being of both the child and the parent will be assessed using the Faces Rating Scale. Participants will be randomly assigned to two groups (Treatment and Active Control) using a block randomization method. In the Active Control group, children will receive only urotherapy education. In the Treatment group, children will receive supervised, online, lumbopelvic exercise-based physiotherapy and rehabilitation sessions, in addition to urotherapy, conducted by a physiotherapist. The sessions will last eight weeks, with a total of 24 sessions. At the end of the eight-week period, both groups will be re-evaluated using the same assessment methods. Intra-group and inter-group comparisons will be completed using appropriate analytical methods.