Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Urethral Strictures (UREGRAFT)
Primary Purpose
Urethral Stricture, Fat Graft
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Direct visual urethrotomy
Autologous fat grafting
Sponsored by
About this trial
This is an interventional treatment trial for Urethral Stricture focused on measuring Urethral Stricture, Fat Graft, Direct Visual Urethrotomy
Eligibility Criteria
Inclusion Criteria:
- Urethral stricture that has re-occurred at least once.
Exclusion Criteria:
- Malignant etiology of urethral stricture
Sites / Locations
- Turku University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Urethral stricture patients
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events at 3 months
Types, severity and probability of procedure related adverse events
Incidence of Treatment-Emergent Adverse Events at 12 months
Types, severity and probability of procedure related adverse events
Secondary Outcome Measures
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.
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.
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.
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.
Change from Baseline Stricture Lumen diameter at 3 months
Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter.
Change from Baseline Stricture Lumen diameter at 12 months
Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04161365
Brief Title
Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Urethral Strictures
Acronym
UREGRAFT
Official Title
Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Urethral Strictures
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 28, 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hannes Kortekangas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture, Fat Graft
Keywords
Urethral Stricture, Fat Graft, Direct Visual Urethrotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Urethral stricture patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Direct visual urethrotomy
Intervention Description
Urethral stricture is treated with urethrotomy under visual control
Intervention Type
Procedure
Intervention Name(s)
Autologous fat grafting
Intervention Description
Autologous fat graft is gathered and injected to stricture
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events at 3 months
Description
Types, severity and probability of procedure related adverse events
Time Frame
3 months
Title
Incidence of Treatment-Emergent Adverse Events at 12 months
Description
Types, severity and probability of procedure related adverse events
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from Baseline Uroflowmetry at 3 months
Description
Measurements in uroflowmetry: Voided urine per unit of time, voided volume, maximum flow rate, curve of the flow.
Time Frame
3 months
Title
Change from Baseline Uroflowmetry at 12 months
Description
Measurements in uroflowmetry: Voided urine per unit of time, voided volume, maximum flow rate, curve of the flow.
Time Frame
12 months
Title
Change from Baseline IPSS at 3 months
Description
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.
Time Frame
3 months
Title
Change from Baseline IPSS at 12 months
Description
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.
Time Frame
12 months
Title
Change from Baseline Stricture Lumen diameter at 3 months
Description
Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter.
Time Frame
3 months
Title
Change from Baseline Stricture Lumen diameter at 12 months
Description
Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter.
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Urethral stricture that has re-occurred at least once.
Exclusion Criteria:
Malignant etiology of urethral stricture
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannes Kortekangas, Surgeon
Phone
+35823139192
Email
hannes.kortekangas@tyks.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauliina Hartiala, Surgeon
Organizational Affiliation
Turku University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Turku University Hospital
City
Turku
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannes A Kortekangas, MD
Phone
+35823139192
Email
hannes.kortekangas@tyks.fi
12. IPD Sharing Statement
Learn more about this trial
Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Urethral Strictures
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