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NCT06795074
Urethral strictures are often initially treated endoscopically with dilatation or direct visual internal urethrotomy (DVIU), a procedure where the stricture is incised through the vision of a cystoscope. These methods are easy to perform, they are often well tolerated under local anesthesia and they have a low risk of complications. One disadvantage is the relatively low success rate which is 20-60% when used as a first intervention and considerably lower after several interventions. Instead of repeated endoscopic procedures, it is advisable to perform open urethroplasty. Urethroplasty has a success rate of 65-91% but a higher risk of complications and requires general anesthesia. Therefore, there is a need for a treatment option for recurrent urethral strictures after DVIU or dilatation, before the urethroplasty is performed. Optilume is a CE-marked paclitaxel-coated dilatation balloon used for treatment of urethral strictures. The industry-sponsored randomised ROBUST III trial from 2022 showed a 75% success rate with Optilume but it is not sure if the results can be generalised to patients who would otherwise be candidates for open urethroplasty and whether the drug coating per se increases the efficacy of balloon dilatation. The aim of this study is to investigate whether the addition of paclitaxel-coating can increase the success rate and decrease the need for additional interventions and open urethroplasty for individuals who has a recurrent urethral stricture following at least one previous endoscopic intervention.
NCT03270384
The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.
NCT05383274
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
NCT05479422
The purpose of this registry is verifying the continued safety and effectiveness of the Optilume DCB clinical use in patients undergoing dilation of the urethral stricture.
NCT06248047
Pelvic fracture is associated with urethral injury in about 10% of patients . The common site of injury is at the bulbomembranous Junction and anastomotic urethroplasty with a tension free anastomosis remains the gold standard management for pelvic fracture urethral injury (PFUI) . Traditional reconstruction of PFUI requires mobilization of the bulbar urethra to reach the prostatic apex with deep dissection of the spongiosum and detachment of the bulb from the perineal membrane at the site of the bulbomembranous urethral injury, a maneuver that requires division of the bulbar arteries . Then, the distal bulb and bulbar urethra will depend on retrograde blood flow through the glans and some perforating branches of the dorsal penile artery and this is usually sufficient to maintain good vitality of the spongiosum and urethra under normal circumstances . When the distal blood supply to the urethra is compromised, either by congenital anomalies such a hypospadias, by previous surgery, or by the pre-existing pelvic fracture, the retrograde flow to the spongiosum is insufficient . In such cases, traditional anastomotic urethroplasty may result in ischemic bulbar necrosis, leading to a reconstructive failure and these patients usually fail to void soon after removal of the catheter, with subsequent retrograde urethrogram (RUG) showing a long bulbar urethral defect . In 2007, Jordan et al described a modification to excision and primary anastomosis (EPA) in the proximal bulbar urethral strictures particularly post radical prostatectomy, which includes mobilizing and preserving the bulbar arteries with the continuity of the corpus spongiosum is maintained . Gomez et al believed that vessel-sparing anastomotic urethroplasty is highly relevant in the PFUI scenario as it can theoretically help to avoid ischemic failure and cold glans syndrome improving sexual arousal. Consequently, they modified the standard reconstructive technique for PFUI by preserving bulbar arterial inflow . So that, we decide to compare between vessel-sparing technique and conventional repair in management of PFUI through a prospective study.
NCT05918315
To evaluate dorsolateral and dorsal approach urethroplasty in treatment of anterior urethral stricture by using buccal mucosal graft as regard voiding and sexual outcomes.
NCT04452890
The choice of the best surgical technique for urethral stricture repair depends on the stricture length. Estimating the length of urethral strictures is therefore of utmost importance. Different clinical studies have proven that SUG has a higher sensitivity to evaluate the length of urethral strictures compared to RUG or VCUG. The goal of this study is to assess the feasibility of using SUG as single pre-operative assessment tool in patients with suspicion of anterior urethral strictures. In this way, use of RUG and/or VCUG could be omitted in the pre-operative work-up of patients with anterior urethral strictures, thereby avoiding significant radiation load of patients.
NCT04650347
Urethral stricture disease is defined as narrowing of the urethral lumen because of fibrosis, which occurs in urethral mucosa and surrounding tissues. The etiology could be congenital, iatrogenic, infectious, or idiopathic. Several techniques are currently available for minimally invasive treatment of urethral strictures, including cold-knife incision, electrocautery, and various types of laser incisions. An incision with the cold knife does not cause any thermal effect on surrounding tissues but should create a mechanical injury that may lead to recurrence in long term. An incision with the electrocautery should cause a significant thermal effect on healthy surrounding tissues resulting in recurrent strictures during follow-up. Laser treatment modalities have gained popularity in the last two decades. the aim of this trial is to evaluate the safety and efficacy of endo-urethrotomy with Holmium laser and cold knife endo-urethrotomy
NCT03851952
The ROBUST IV study is designed to collect and better understand "real-world" outcomes for men undergoing urethral dilation using the Optilume Drug Coated Balloon (DCB) for treatment of urethral stricture.
NCT03061344
Study Objectives The current definitive treatment options for urethral stricture disease include endoscopic urethrotomy known as Direct Vision Internal Urethrotomy (DVIU) or open reconstruction known as urethroplasty (1-6). The purpose of this study is to determine feasibility of endoscopic-only repair of urethral stricture or bladder neck contracture using a combination of existing surgical techniques of internal urethrotomy (or bladder neck incision) augmented by buccal mucosal graft.
NCT01889888
Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System (Cytori Therapeutics Inc)from a portion of the fat harvested from the patient's front abdominal wall. ADRC will be administered one-time endoscopically into submucosal layer of urethra under eye control into the stricture site after mechanical dilation. This is a single arm study with no control. All patients receive cell therapy.
NCT00535717
Uttarbasti is per urethral administration of medicated oil which has been recommended by Sushrut for urinary track disorders. As far as conventional surgery is concerned urethral stricture still remains a challenge due to post procedural high recurrences and complications Uttarbasti being almost non invasive, with minimum recurrences and most economical, easy to practice OPD procedure, can be the treatment of choice in the management of urethral stricture.