Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Urethral Strictures (UREGRAFT)

In this study the investigators investigate the feasibility and therapeutic potential of free autologous fat grafting combined to direct visual urethrotomy (DVIU) in the treatment of urethral strictures.

Study Overview

• Status: Recruiting
• Conditions: Urethral Stricture; Fat Graft
• Intervention / Treatment: Procedure: Autologous fat grafting; Procedure: Direct visual urethrotomy

Detailed Description

In this study the investigators wish to proof the concept of free fat grafting into urethral stricture via urethroscope. The investigators will recruit twenty male patients suffering from (endoscopy proven) benign stricture of spongy urethra. All recruited patients have undergone at least one direct visual internal urethrotomy (DVIU) before recruitment. IPSS-score and uroflowmetry are recorded upon recruitment. The IPSS-score is repeated one day preoperatively. Urine sample is gathered for bacterial and cytological analysis. Prophylactic single dose levofloxacin antibiotic is orally administered before operation.

The operation is performed in the operation room by one urologist and one surgeon under general anesthesia. First abdominal liposuction (roughly 20 ml) and fat graft preparation is performed. The fat graft is processed into nano-fat using Tulip GEMS Single-Use NanoTransfer Set. Then urethroscopy is performed, urethral stricture is visually graded (location, length, lumen), photographed, DVIU performed and nano fat graft (0,1-0,5ml) injected to stricture site beneath the mucosal layer at three locations. Urinary Foley ch 18 catheter is inserted. Patients are discharged the next day. Urinary catheter is removed after 20 hours.

Patients are contacted by phone 1 week after the operation. Post-operative symptoms are recorded and the patients are requested to contact the researcher if needed. Patient records are screened for pre- and postoperative symptoms, medication, long term illnesses and possible postoperative contacts to the hospital.

Three months later uroflowmetry, urethroscopy and IPSS-questionnaire are repeated. Stricture site is photographed and visually graded. In case of symptomatic re-stricture, the DVIU and fat grafting is repeated once. After 12 months uroflowmetry and IPSS-questionnaire are repeated. In case of suspected re-stricture the urethroscopy is repeated. Follow-up time is 12 months from the last fat graft injection.

Trial starts in fall 2019. The clinical studies have been completed and the data analysis and writing of the manuscript will be finalized in 2022.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannes Kortekangas, Surgeon; Phone Number: +35823139192; Email: hannes.kortekangas@tyks.fi

Study Locations

• Finland
  • Turku, Finland
    • Recruiting
    • Turku University Hospital
    • Contact: Hannes A Kortekangas, MD; Phone Number: +35823139192; Email: hannes.kortekangas@tyks.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Urethral stricture that has re-occurred at least once.

Exclusion Criteria:

• Malignant etiology of urethral stricture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Urethral stricture patients; Patients suffering from urethral stricture are treated with direct visual internal urethrotomy (DVIU). Free fat graft is gathered from the abdominal subcutaneous fat. Fat graft is prepared and injected to the stricture site.	Procedure: Autologous fat grafting; Autologous fat graft is gathered and injected to stricture; Procedure: Direct visual urethrotomy; Urethral stricture is treated with urethrotomy under visual control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events at 3 months	Types, severity and probability of procedure related adverse events	3 months
Incidence of Treatment-Emergent Adverse Events at 12 months	Types, severity and probability of procedure related adverse events	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Stricture Lumen diameter at 3 months	Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter.	3 months
Change from Baseline Stricture Lumen diameter at 12 months	Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter.	12 months
Change from Baseline Uroflowmetry at 3 months	Measurements in uroflowmetry: Voided urine per unit of time, voided volume, maximum flow rate, curve of the flow.	3 months
Change from Baseline Uroflowmetry at 12 months	Measurements in uroflowmetry: Voided urine per unit of time, voided volume, maximum flow rate, curve of the flow.	12 months
Change from Baseline IPSS at 3 months	International Prostate Symptom Score (IPSS) is a validated symptom questionnaire used to measure voiding symptoms. Subscales: Incomplete emptying, frequency, intermittency, urgency, weak stream, straining, nocturia. Each sub scale 0-5 points. Zero points equal no symptoms and 5 points equal worst possible symptoms. Total 0-35 points.	3 months
Change from Baseline IPSS at 12 months	International Prostate Symptom Score (IPSS) is a validated symptom questionnaire used to measure voiding symptoms. Subscales: Incomplete emptying, frequency, intermittency, urgency, weak stream, straining, nocturia. Each sub scale 0-5 points. Zero points equal no symptoms and 5 points equal worst possible symptoms. Total 0-35 points.	12 months

Collaborators and Investigators

• Sponsor: Hannes Kortekangas

Study record dates

Study Major Dates

• Study Start (Anticipated): May 28, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: July 29, 2019
• First Submitted That Met QC Criteria: November 9, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Urethral Stricture; Fat Graft; Direct Visual Urethrotomy
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urethral Diseases; Urethral Obstruction; Constriction, Pathologic; Urethral Stricture
• Other Study ID Numbers: UREGRAFT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No