Urethral StrictureUREGRAFTNCT04161365
Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Urethral Strictures
A study testing Direct visual urethrotomy and Autologous fat grafting in people with Urethral Stricture and Fat Graft, run by Hannes Kortekangas at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Urethral Stricture, Fat Graft
- What is being tested?
- Direct visual urethrotomy and Autologous fat grafting
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 28 May 2021to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urethral stricture that has re-occurred at least once.
Who cannot join
- Malignant etiology of urethral stricture
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku
Hannes A Kortekangas, MD, +35823139192, hannes.kortekangas@tyks.fi
About this study
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.
Read the 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.
- Conditions
- Urethral Stricture, Fat Graft
- Being tested
- Direct visual urethrotomy, Autologous fat grafting
- Keywords
- Urethral Stricture, Fat Graft, Direct Visual Urethrotomy
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct visual urethrotomyProcedure or surgery
Urethral stricture is treated with urethrotomy under visual control
Autologous fat graftingProcedure or surgery
Autologous fat graft is gathered and injected to stricture
| Study group | Role | What they receive |
|---|---|---|
| Urethral stricture patients | Experimental | 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. Receives: Procedure: Direct visual urethrotomy; Procedure: Autologous fat grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events at 3 months
Types, severity and probability of procedure related adverse events
Measured: 3 months
Incidence of Treatment-Emergent Adverse Events at 12 months
Types, severity and probability of procedure related adverse events
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Change from Baseline Stricture Lumen diameter at 3 months
Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter.
Measured: 3 months
Change from Baseline Stricture Lumen diameter at 12 months
Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start28 May 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannes Kortekangas
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Hannes Kortekangas, Turku University Hospital
- Investigators
- Pauliina Hartiala, Surgeon, Study director, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161365
- Sponsor's protocol ID
- UREGRAFT
- Acronym
- UREGRAFT
- Status last verified
- May 2021
- First submitted
- 29 Jul 2019
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Urethral Strictures
- ClinicalTrials.gov ID
- NCT04161365
- Acronym / sponsor ID
- UREGRAFT / UREGRAFT
- Conditions
- Urethral Stricture, Fat Graft
- Keywords
- Urethral Stricture, Fat Graft, Direct Visual Urethrotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hannes KortekangasOther government
- Study start
- 28 May 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urethral stricture patients | Experimental | Procedure: Direct visual urethrotomy, Procedure: Autologous fat graftingPatients 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Urethral stricture that has re-occurred at least once.
Key exclusion criteria (1 listed)
- Malignant etiology of urethral stricture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct visual urethrotomyUrethral stricture is treated with urethrotomy under visual control | Procedure or surgery | Urethral stricture patients |
| Autologous fat graftingAutologous fat graft is gathered and injected to stricture | Procedure or surgery | Urethral stricture patients |
Primary outcome
Incidence of Treatment-Emergent Adverse Events at 3 months
Time frame: 3 months
Types, severity and probability of procedure related adverse events
Incidence of Treatment-Emergent Adverse Events at 12 months
Time frame: 12 months
Types, severity and probability of procedure related adverse events
6 secondary outcomes
Change from Baseline Uroflowmetry at 3 months
Time frame: 3 months
Change from Baseline Uroflowmetry at 12 months
Time frame: 12 months
Change from Baseline IPSS at 3 months
Time frame: 3 months
Change from Baseline IPSS at 12 months
Time frame: 12 months
Change from Baseline Stricture Lumen diameter at 3 months
Time frame: 3 months
Change from Baseline Stricture Lumen diameter at 12 months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
Related trials for Urethral Stricture
RecruitingObservational study
Observational Study of the LambdaGuide System for Measurement of Observable Genitourinary Anatomy During Cystoscopic Procedures in Men
Genitourinary Anatomy
RecruitingObservational study
Urethral Resistive Index (URI): A New Parameter for Diagnosing Urethral Obstruction
Urethral Stricture
Recruiting
Intraoperative Lidocaine or Dexmedetomidine for Postoperative Pain Modulation After Urethral Reconstruction.
Urethral Stricture
Active, not recruiting
Outcomes of Double-face Augmentation Urethroplasty
Urethral Stricture, Anterior, Urethral Stricture Disease
Active, not recruitingPhase 4
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Urethral Stricture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauliina Hartiala, Surgeon study director
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct visual urethrotomy and Autologous fat grafting in people with Urethral Stricture and Fat Graft, run by Hannes Kortekangas at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannes Kortekangas, Surgeon (+35823139192, hannes.kortekangas@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events at 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.