Treatment Trials

16 Clinical Trials for Various Conditions

Focus your search

ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Description

ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).

Conditions

Urethral Stricture

Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Description

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.

Conditions

Urethral Stricture

ROBUST I Pilot Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Description

Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.

Conditions

Stricture Urethra

Memokath® 044TW Stent for Treatment of Urethral Stricture
Description

The purpose of this study is to evaluate if the placement of a temporary urethral stent for up to 12 months, following dilation or internal urethrotomy (cutting open), results in a higher rate of urethral patency during the first year of follow-up when compared to the control group that does not receive a stent.

Conditions

Urethral Stricture

Mobile Health Application to Improve Patient Satisfaction After Urethroplasty
Description

Create a custom urethroplasty mobile application that will guide patients through through the surgical process.

Conditions

Urethral Stricture

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Description

Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.

Conditions

Urethral Stricture

Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty
Description

Patients undergoing buccal urethroplasty will often have significant post-operative oral pain from the graft site. Various graft harvest techniques and methods for post-harvest hemostasis including graft site closure have been explored. Despite the frequency of this clinical scenario there is no established best practice for peri-operative pain management in this patient population. In addition to traditional post operative pain control, groups have sought various peri-operative anesthetic regimens to improve post operative pain. This has led recently to the description of various regional blocks including buccal and periorbital blocks for peri-operative local anesthetic. No study has looked at superiority of regional pain management in this patient population. This study will aim to assess three established anesthetic protocols for oral pain control in a blinded, randomized controlled trial. Hypothesis: Patients who have buccal block will have lower post op pain without any increase adverse oral outcomes.

Conditions

Urethral Stricture, Male

Liposomal Bupivacaine To Control Post-Operative Pain Following BMG
Description

This is a single blinded-randomized controlled trial that recruit male patients for substitution urethroplasty using buccal mucosal graft. The study investigators aim to assess the efficacy and safety of liposomal bupivacaine injection to the buccal graft harvest site on post-operative main score, morphine equivalence requirement and oral morbidities.

Conditions

Urethral Stricture

VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures.
Description

The investigators want to verify whether the surgical outcome of vessel-sparing anastomotic repair in isolated short bulbar urethral strictures is not inferior to the surgical outcome of transecting anastomotic repair. Furthermore, the investigators compare the functional outcome of both techniques verifying if there is less erectile dysfunction after vessel-sparing anastomotic repair than after transecting anastomotic repair.

Conditions

Urethral Stricture, Surgery, Urologic Diseases

Liquid Buccal Mucosa Graft Urethroplasty
Description

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.

Conditions

Urethral Stricture

Clostridium Histolyticum Collagenase Injection for Urethral Disease
Description

The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures.

Conditions

Urethral Stricture

A Study of Dorsal Versus Ventral Buccal Mucosa Graft Onlay for Bulbar Urethroplasty
Description

The investigators propose a randomized non-blinded comparison of dorsal vs. ventral approach for buccal mucosa graft urethroplasty in the bulbar urethra. Buccal mucosa graft is a common method of repairing the strictured urethra. Current evidence suggests the two approaches for placement of the graft are equally successful at correcting the stricture and the two approaches have similar risks of complications. The investigators propose to randomly assign appropriately selected patients to either a dorsally- or ventrally-placed graft. No additional procedures beyond normal care protocol will be required of the patients. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at two years.

Conditions

Urethral Stricture

Dorsal vs. Ventral Buccal Graft Dorsal vs. Ventral Buccal Graft
Description

This is a randomized non-blinded comparison of dorsal vs. ventral approach for buccal mucosa graft urethroplasty in the bulbar urethra. Buccal mucosa graft is a common method of repairing the strictured urethra. Current evidence suggests the two approaches for placement of the graft are equally successful at correcting the stricture and the two approaches have similar risks of complications. The investigators propose to randomly assign appropriately selected patients to either a dorsally- or ventrally-placed graft. No additional procedures beyond the normal care protocol will be required of the patients. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at two years.

Conditions

Urethral Stricture

Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty
Description

The investigator's study aims to see if an enhanced recovery regimen of pain medications before and during surgery will decrease the use and risk of opioid pain medications as well as improve pain control in anterior urethroplasty patients. Participants will be randomized to one of two pain regimens (enhanced recovery regimen vs standard regimen).

Conditions

Pain, Postoperative, Urethral Stricture

Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures
Description

This is a Phase I clinical study to determine the safety and efficacy of using autologous, engineered urethral constructs for the treatment of urethral strictures in adult males. The proposed study design is a prospective non-randomized and uncontrolled single-center investigation. Autologous urothelial cells (UCs) and smooth muscle cells (SMCs), obtained from enrolled male subjects' bladder tissue samples, will be culture expanded in vitro and used to seed tubular PGA scaffolds to create autologous urethral constructs for the repair of urethral strictures.

Conditions

Urologic Diseases, Male Urogenital Diseases, Urethral Stricture, Urethral Injury

Effect of Caudal and Penile Block on Hypospadias Repair Complications
Description

Hypospadias is one of the most common genitourinary (GU) malformations, seen in approximately 1 of 250 male live births. Common methods of local anesthesia administration for hypospadias surgery include caudal and dorsal penile nerve blocks. While both methods are known to be effective with minimal risk, the effect on post-operative complications is not well-established. The purpose of this randomized controlled trial is to evaluate if caudal versus dorsal penile nerve block results in higher rates of post-operative complications.

Conditions

Hypospadias