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Lower Urinary Tract Symptoms clinical trials

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NCT ID: NCT05157529 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

AQUABEAM® Robotic System and Ultrasound Accessories

AQUA
Start date: February 16, 2023
Phase: N/A
Study type: Interventional

Lower urinary symptoms (LUTS) affect many older men and their frequency and severity increase with age. In the age group between 65 and 79 years the rate of men with moderate and severe LUTS is 20 - 25% (Hunter et al. 1994). The complaints are potentially associated with a considerable impairment of the quality of life (Trueman et al. 1999). LUTS in older men are commonly caused by a bladder outlet obstruction (BOO) secondary to benign prostatic enlargement (BPE). The histological term "benign prostatic hyperplasia" (BPH) is frequently used in literature and clinical practice as a synonym for this diagnosis. Surgical therapy of BPH has continuously evolved in recent years. One of the latest technologies for transurethral prostate desobstruction is the Aquablation therapy, first described in 2015 (AQUABEAM®, PROCEPT BioRobotics, Redwood Shores, CA, USA) (Faber et al 2015). The AQUABEAM Robotic System is the first and only image-guided, heat-free robotic therapy for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). It is designed for cutting of prostate tissue during a minimally invasive surgical procedure. Once inserted via a transurethral approach and advanced through the urethra and into the prostatic urethra, the device applies an ultrasound-guided water jet that precisely ablates the prostate tissue. Aquablation therapy is unique in that it combines cystoscopic visualization, ultrasound imaging and advanced planning software to provide the surgeon with a multidimensional view of the treatment area. This enables personalized treatment planning for the patient's unique anatomy, improved decisionmaking and real-time monitoring during the procedure. This prospective single-arm investigational clinical trial aims at assessing the efficacy and safety of the new generation of the AQUABEAM Robotic System (P1G3) and the Apogee 2300 Ultrasound System and compare the percentage of patients who are discharged the day of the surgery among different groups of BPH patients who undergo aquablation using the third generation of the AQUABEAM Robotic System.

NCT ID: NCT05146674 Not yet recruiting - Clinical trials for Lower Urinary Tract Symptoms

Impact of Tadalafil 5 mg on Post-micturition Dribble in Young-age Men With no/Mild Lower Urinary Tract Symptoms

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

The primary objective of this prospective, single-centre randomized controlled trial is to assess the efficacy of tadalafil 5 mg on post-micturition dribble (PMD) in young age men (18-50 years) with no/mild lower urinary tract symptoms (LUTS).

NCT ID: NCT05146258 Completed - Clinical trials for Lower Urinary Tract Symptoms

Voiding Class Study for Symptom Reduction and Quality of Life in Children With LUTS

Start date: April 14, 2021
Phase:
Study type: Observational

Lower urinary tract dysfunction (LUTD) is a common pathology within children and shows a wide spectrum of lower urinary tract symptoms (LUTS). These symptoms have a significant impact on a child's well-being. For the treatment of LUTS in children urotherapy, a non-medicamentous form of therapy, is implemented as standard therapy. It can be described as a bladder re-education and rehabilitation programme where the participants are informed on the anatomy and physiology of the normal and pathological urinary system. Urotherapy has been offered as individual therapy for a long time but is now also offered as group therapy (the voiding school). This is, as compared to the individual therapy, more cost-effective and gives the participants the feeling not to be alone in the situation. The effectiveness of the individual therapy for children with LUTD has already been determined, however little research has been done on the effectiveness of urotherapy in group (the voiding class). The present study wants to investigate the effect of the group therapy on the symptoms and quality of life of children with LUTD.

NCT ID: NCT05130918 Completed - Clinical trials for BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Efficacy of Mictalase® After ThuLEP

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

In this single-center, prospective, randomized, open label, phase-III study, patients with indication to Thulium Laser Enucleation of Prostate were enrolled. The report conformed to CONSORT 2010 guidelines. Eligible patients were 1:1 randomized. Randomization defined Group A: patients who were administered Phenolmicin P3 and Bosexil suppositories twice a day for 5 days, then once a day for other 10 days; Group B: patients who did not receive the suppositories ("controls"). Study endpoints were evaluated at 15 and 30 days postoperation. Primary endpoint included evaluation of effects of the suppository on irritative symptoms by administering International Prostate Symptom Score (IPSS) with Quality of Life (QoL) questionnaire. Secondary endpoint included evaluation of effects on urinary tract infections by performance of urinalysis with urine culture.

NCT ID: NCT05069376 Completed - Clinical trials for Lower Urinary Tract Symptoms

Effect of Ureteral Stents Length and Location on Related Symptom

Start date: June 12, 2018
Phase: N/A
Study type: Interventional

This is a prospective randomized clinical trial, evaluating the effect of the intra-ureteral placement of the stent's distal end versus the conventional stent placement on the postoperative LUTS and pain.

NCT ID: NCT05060211 Completed - Cerebral Palsy Clinical Trials

Incontinence and MRI Results in Children With Cerebral Palsy

Start date: October 25, 2021
Phase:
Study type: Observational

More than 50 % of children and adults with cerebral palsy experience lower urinary tract symptoms (LUTS). This can negatively influence quality of life of the child and the total social environment. Previous research demonstrated that the brain lesion, characteristic for cerebral palsy (CP), is a prognostic factor for the functional abilities of a child with CP. Previous research within our department demonstrated functional impairment as a risk factor for incontinence. This demonstrates an indirect connection between the brain lesion and incontinence of a child with CP. However, this connection isn't alway correct as some children with high functionality also demonstrate incontinence. As bladder control is also regulated by higher brain centers, the present study wants to investigate a direct connection between the brain lesion of the child, visible by means of MRI, and the incontinence status of the child. .

NCT ID: NCT05017415 Completed - Cerebral Palsy Clinical Trials

Applicability of Uroflowmetry in Children With Cerebral Palsy

Start date: October 14, 2021
Phase: N/A
Study type: Interventional

Until now, the use of invasive urodynamics with use of catheters is still the gold standard for lower urinary tract evaluation in subjects with CP. This suggests a psychological and physical impact of invasive urodynamics in subjects with CP and further demonstrates the need to avoid standard use of invasive urodynamics in children and adults with CP. The current study will evaluate usefulness of uroflowmetry, correlation between uroflowmetry parameters and different lower urinary tract symptoms will be investigated. Secondly, results of uroflowmetry indicating possible vulnerability of the upper urinary tract will be defined.

NCT ID: NCT04987138 Active, not recruiting - Clinical trials for Lower Urinary Tract Symptoms (LUTS)

Safety and Effectiveness Study of the Zenflow Spring System

BREEZE
Start date: September 30, 2021
Phase: N/A
Study type: Interventional

Evaluate the safety and effectiveness of the Zenflow Spring System in relieving LUTS associated with BPH.

NCT ID: NCT04979143 Not yet recruiting - Clinical trials for Benign Prostatic Hyperplasia

Moses Vaporization: Is Use of Moses 2.0 in Holmium Laser Ablation of the Prostate More Efficient

Moses 2
Start date: December 30, 2021
Phase: N/A
Study type: Interventional

To determine if use of Moses 2.0 results in improved ablation efficiency during holmium laser vaporization of the prostate. To determine if use of Moses 2.0 results in less char, improved visibility, and improved hemostasis in prostate vaporization.

NCT ID: NCT04928716 Completed - Multiple Sclerosis Clinical Trials

Multiple Sclerosis and Voiding Symptoms: How to Assess?

Start date: January 1, 2019
Phase:
Study type: Observational

In multiple Sclerosis (MS), storage and voiding symptoms are well described. Urodynamic patterns underlying storage symptoms are clearly defined, but the assessment of voiding phase in neurological diseases is a sensitive topic. The international continence society (ICS) recommended performing pressure flow studies to assess voiding phase. Assessments of sphincter relaxation and detrusor contractility during voiding phase are tough aims to achieve. Indeed, there is no consensus for the detrusor contractility assessment on women or on patients with neurogenic bladder. Similarly, assessment of sphincter during bladder filling and during the voiding phase is not included in ICS recommendations. In the end, it is the physicians who conclude from the non-formalized urodynamic data if there is a DSD or detrusor underactivity. In MS patients undergoing urodynamics, studies reported 43% DSD and 12% impaired contractility. These data should be interpreted with caution due to the variability of the assessment methods. This study aims to describe the voiding phase of MS patients with standardized urodynamic evaluation and parameters. This prospective observational study was conducted in a neuro-urology department of a French university hospital. All the MS patients consulting for a first urodynamic evaluation without urinary treatment were included. Standardized urodynamic evaluation included an uroflowmetry, urethral pressure profile, two pressure-flow studies. If no detrusor contractility was observed during the pressure flow studies, cystometries with 100ml/min filling rate and ice water test were performed. Anal sphincter activity was recorded using surface electromyography electrodes. Demographic data (age, sex), disease course of the MS, treatments, Expanded Disability Status Scale, urinary symptoms using the Urinary Symptom Profile and the Neurogenic Bladder Symptom Score were collected. For assessment of detrusor contractility, the following parameters are reported: the bladder voiding efficiency; the projected isovolumetric pressure (PIP) or bladder contractility index (BCI); the Watts factor. For women, the investigators presented 3 more parameters the PIP1; the Valentini-besson-Nelson parameter k and an urodynamic cut-off proposed by Gammie et al. for DUA. Presence of Detrusor-sphincter dyssynergia was reported if there were a detrusor contraction concurrent with an involuntary contraction of the periurethral striated muscle.