The goal of this clinical investigation is to evaluate whether the Hydrustent® medical device is safe and if maintain the urinary flow inside the ureter in adults. The main questions it aim to answer are: * Does Hydrustent® maintain urinary patency post-surgery in adults? * What medical issues do participants experience while using Hydrustent®? Researchers will compare the Hydrustent® medical device to a comparator (a standard medical device used in clinical practice) to determine whether Hydrustent® is at least non-inferior in terms of safety and efficacy. Other questions that the study will answer are: * Does Hydrustent® exhibit a durability of at least 24 hours? * Does Hydrustent® prevents the need of the surgical procedure to remove the ureteral stent? * Does Hydrustent® reduce urinary symptoms associated with a ureteral stent? Participants will: * Have either the Hydrustent® or a comparator device inserted following the removal of ureteral or renal stones via endourological techniques. * Be monitored for 3 months post-surgery through regular follow-up visits. * Complete questionnaires and undergo imaging exams, as well as blood and urine analyses to assess recovery.
Multicentric, randomized, controlled clinical study comprising both phases of the pre-market device clinical development stage: pilot and pivotal. The first exploratory phase of the study (16 participants) will assess the safety of Hydrustent® for the first time in humans, while providing preliminary results on its efficacy. Following this, the second phase is confirmatory (118 participants), allowing the collection of the information necessary to evaluate the clinical performance and safety of Hydrustent®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
134
This ureteral stent is based on natural polymers and degrades inside the human body without causing obstruction, avoiding the need of a second surgery for stent removal and minimizing complications related to encrustation and bacterial infections.
This ureteral stent is a double J made of 100% polyurethan, heat-sensitive and radiopaque for excellent patient tolerance and high incrustation resistance.
Unidade Local de Saúde da Região de Aveiro (ULSRA), E.P.E.
Aveiro, Aveiro District, Portugal
Unidade Local de Unidade Local de Saúde do Alto Ave (ULSAAVE), E.P.E
Guimarães, Braga District, Portugal
Hospital CUF Tejo
Lisbon, Portugal
Unidade Local de Saúde do Alto Minho (ULSAM)
Viana do Castelo, Portugal
Primary safety endpoint assessed through adverse events and device deficiencies (Pilot and pivotal phases)
Evaluation of the number, severity, and intensity of AEs and DDs at least possibly related to either the investigational device or the comparator device that occurred within 28±1 days of stent placement.
Time frame: From surgery to the end of treatment at day 28
Primary efficacy outcome assessed by the urine drainage after stent placement (Pivotal phase)
Urine patency will be assessed using a composite endpoint based on the following criteria: 1. Diuresis (range within 0.5 to 1.5 mL/kg/h). 2. Creatinine levels in blood tests (range within 0.7 to 1.2 mg/dL for men and 0.5 to 1.0 mg/dL for women). 3. CT scan to assess the adequate upper urinary tract urine drainage (defined as the absence of significative hydronephrosis) 4. Lack of surgical intervention in the stented ureter.
Time frame: From surgery to day 1
Overall clinical success (efficacy) by evaluating the urine drainage after stent placement (Pilot phase)
Urine patency will be assessed using a composite endpoint based on the following criteria: 1. Diuresis (range within 0.5 to 1.5 mL/kg/h). 2. Creatinine levels in blood tests (range within 0.7 to 1.2 mg/dL for men and 0.5 to 1.0 mg/dL for women). 3. CT scan to assess the adequate upper urinary tract urine drainage (defined as the absence of significative hydronephrosis) 4. Lack of surgical intervention in the stented ureter.
Time frame: From surgery to the end of treatment at day 28
Overall clinical success by evaluating the urine drainage after stent placement (Pivotal phase)
Urine patency will be assessed using a composite endpoint based on the following criteria: 1. Creatinine levels in blood tests (range within 0.7 to 1.2 mg/dL for men and 0.5 to 1.0 mg/dL for women). 2. CT scan to assess the adequate upper urinary tract urine drainage (defined as the absence of significative hydronephrosis) 3. Lack of surgical intervention in the stented ureter.
Time frame: From surgery to the end of treatment at day 28
Overall safety assessed through adverse events and device deficiencies (Pilot and pivotal phases)
Evaluation of the number, severity, and intensity of AEs at least possibly related to the devices occurring and number, type and severity of DDs.
Time frame: From surgery to the end of study at day 90
Assessment of the durability of the experimental device (Pilot and pivotal phases)
Presence of an intact device with no radiographic evidence of breakage or dissolution assessed by radiological assessment
Time frame: Day 1
Technical success of the experimental device (Pilot and pivotal phases)
Complete degradation of the investigational stent as measured by radiological assessment (CT scan).
Time frame: Day 28
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
Assessment of urinary symptoms via the Ureteral Stent Symptom Questionnaire (USSQ). The total score of the questionnaire is the sum of all items across the following symptom sections: urinary symptoms, pain, sexual issues, general health, and work performance. A higher total score reflects a greater burden of symptoms and worse quality of life.
Time frame: Screening phase, during the treatment phase and up to the end of the study at day 90
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
Assessment of urinary symptoms via the Visual Analog Scale (VAS). Study participants mark their symptom intensity on a continuous line 10 centimetres long, the extremes of which indicate "no pain" and "maximum pain". A higher score indicates greater pain intensity.
Time frame: Screening phase, during the treatment phase and up to the end of the study at day 90
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
Assessment of urinary symptoms via the need of pain medication. If intervention for pain management is required, it suggests that the urinary symptoms are more severe.
Time frame: During the treatment phase and up to the end of the study at day 90
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
Assessment of urinary symptoms via the International Index of Erectile Function (IIEF-5) for male participants. The 5-item tool, with each item scored from 1 to 5, generates a total score ranging from 5 to 25 points. Lower scores indicate poorer sexual functioning, while higher scores reflect better erectile functioning.
Time frame: Screening phase, during the treatment phase and up to the end of the study at day 90
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
Assessment of urinary symptoms via the International Prostate Symptom Score (IPSS) for male participants. The questionnaire consists of two sections: fhe first section includes a 7-item tool, with each item scored from 0 to 5, generating a total score ranging from 0 to 35 points. The second section assesses quality of life, with scores ranging from 0 to 6. Lower scores indicate fewer urinary symptoms and better quality of life related to urinary symptoms.
Time frame: Screening phase, during the treatment phase and up to the end of the study at day 90
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