Liquid Buccal Mucosa Graft Urethroplasty

NCT03061344 | Unknown Phase 1 FDA Drug

• 1 other identifier: SUNYUpstateMU
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Voiding Surgical Outcomes: Stricture Recurrence

  The ultimate outcome of this procedure is number of patients successfully treated without need for re-intervention (such as need for urethral dilation, endoscopic manipulation or open reconstruction). Recurrence of stricture will be reported as number of events. To detect stricture recurrence, patients will be monitored with: peak urine flow (milliliters per second) and post-void residuals (milliliters) and will be assessed post- operatively at every visit up to three years Flexible cystoscopy will be offered to patients at one year follow up or at any time point if there is suspicion of stricture recurrence based on patients complaints (reported as number of recurrences).

  3 years

Secondary Outcomes (3)

• Immediate Perioperative Outcomes

  Day of surgery

• Short-term Postoperative Outcomes

  Up to 90 days

• Patient Satisfaction

  Post-operative up to 3 years follow up

Study Arms (1)

liquid buccal mucosa graft

EXPERIMENTAL

DVIU treated with liquid buccal mucosal graft; endoscopic injection of morcellated buccal mucosal graft mixed with fibrin glue

Biological: DVIU treated with liquid buccal mucosal graft

Interventions

DVIU treated with liquid buccal mucosal graft BIOLOGICAL

DVIU treated with liquid buccal mucosal graft; internal urethrotomy for urethral stricture followed by injection of morcellated buccal mucosal graft mixed with fibrin glue (Tisseel, Baxter)

liquid buccal mucosa graft

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male \>18 years of age
• bulbar urethral stricture
• bladder neck contracture

You may not qualify if:

• \<18 years old
• developmental delay
• incarcerated individuals,
• history of prior urethroplasty
• history of cerebrovascular diseases (prior stroke, MI)
• history of deep vein thrombosis
• history of pulmonary embolism
• history of clotting disorders
• factor 5 Leiden
• antiphospholipid antibody syndrome
• prothrombin gene mutation
• protein S deficiency
• protein C deficiency
• dysfibrinogenemia
• polycythemia vera

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Dmitriy Nikolavsky, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitriy Nikolavsky, MD

CONTACT

315-464-1500; nikolavd@upstate.edu

Janice Sell

CONTACT

315-464-6114; sellj@upstate.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: February 23, 2017
• Study Start: February 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2021
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)