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

Urethral Stricture Clinical Trial

— UREGRAFT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04161365
• Other study ID #: UREGRAFT
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2021
• Est. completion date: March 2023

Study information

• Verified date: May 2021
• Source: Turku University Hospital
• Contact: Hannes Kortekangas, Surgeon
• Phone: +35823139192
• Email: hannes.kortekangas[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2023
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Malignant etiology of urethral stricture

Related Conditions & MeSH terms

• Constriction, Pathologic
• Fat Graft
• Urethral Stricture

Intervention

Procedure:
• Direct visual urethrotomy
Urethral stricture is treated with urethrotomy under visual control
• Autologous fat grafting
Autologous fat graft is gathered and injected to stricture

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Hannes Kortekangas

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events at 3 months	Types, severity and probability of procedure related adverse events	3 months
Primary	Incidence of Treatment-Emergent Adverse Events at 12 months	Types, severity and probability of procedure related adverse events	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from Baseline Stricture Lumen diameter at 3 months	Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter.	3 months
Secondary	Change from Baseline Stricture Lumen diameter at 12 months	Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter.	12 months