Clinical trial NCT04161365: Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Urethral Strictures
Official title: Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Urethral Strictures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urethral Stricture
Fat Graft
Keywords: Urethral Stricture
Fat Graft
Direct Visual Urethrotomy
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2019-11-13
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Malignant etiology of urethral stricture

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events at 3 months
timeFrame: 3 months
measure: Incidence of Treatment-Emergent Adverse Events at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change from Baseline Uroflowmetry at 3 months
timeFrame: 3 months
measure: Change from Baseline Uroflowmetry at 12 months
timeFrame: 12 months
measure: Change from Baseline IPSS at 3 months
timeFrame: 3 months
measure: Change from Baseline IPSS at 12 months
timeFrame: 12 months
measure: Change from Baseline Stricture Lumen diameter at 3 months
timeFrame: 3 months
measure: Change from Baseline Stricture Lumen diameter at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Pauliina Hartiala, Surgeon
role: STUDY_DIRECTOR
References: