Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Urethral Strictures
NCT ID: NCT04161365
Last Updated: 2021-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-05-28
2023-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Direct visual urethrotomy
Urethral stricture is treated with urethrotomy under visual control
Autologous fat grafting
Autologous fat graft is gathered and injected to stricture
Interventions
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Direct visual urethrotomy
Urethral stricture is treated with urethrotomy under visual control
Autologous fat grafting
Autologous fat graft is gathered and injected to stricture
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
99 Years
MALE
No
Sponsors
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Hannes Kortekangas
OTHER_GOV
Responsible Party
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Hannes Kortekangas
Gastrointestinal surgeon / Consultant in Division of Gastrointestinal Surgery
Principal Investigators
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Pauliina Hartiala, Surgeon
Role: STUDY_DIRECTOR
Turku University Hospital
Locations
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Turku University Hospital
Turku, , Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UREGRAFT
Identifier Type: -
Identifier Source: org_study_id
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