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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Urethral Stricture, Fat Graft

Intervention / Treatment
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* Procedure: Direct visual urethrotomy
* Procedure: Autologous fat grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Urethral stricture that has re-occurred at least once. Exclusion Criteria: Malignant etiology of urethral stricture

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urethral stricture patients<br>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: Direct visual urethrotomy<br>* Urethral stricture is treated with urethrotomy under visual control<br>Procedure: Autologous fat grafting<br>* Autologous fat graft is gathered and injected to stricture<br>|

What is the study measuring?
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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 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urethral Stricture, Fat Graft, Direct Visual Urethrotomy