Urethral Stricture, BulbarNCT07220980
Optimal Duration of Foley Catheter After Bulbar Urethroplasty
A study testing Early catheter removal and Later catheter removal in people with Urethral Stricture, Bulbar, run by Jane Kurtzman at 4 sites in United States.
Trial summary
The goal of this clinical trial is to learn when is the best time to remove a Foley catheter (tube used to drain urine from the bladder) after surgery in adult men who have a specific type of urethral stricture disease (narrowing of the tube that carries urine from the body). Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Urethral Stricture, Bulbar
- What is being tested?
- Early catheter removal and Later catheter removal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Aug 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cis-male patients
- Age 18-70, inclusive
- Bulbar urethral stricture undergoing a urethroplasty
- Urethral stricture defect less than or equal to 7cm in length
- First time urethroplasty
- Negative urine analysis or urine culture
Who cannot join
- History of pelvic radiation
- Diabetes with Hba1c greater than 8%
- Penile urethral stricture
- Posterior urethroplasty
- Bulbar stricture greater than 7cm
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Western New York Urology Associates
Buffalo, New York, 14203
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Ohio State University
Columbus, Ohio, 43212
University of Utah Hospital
Salt Lake City, Utah, 84132
About this study
Official title: Optimal Duration of Indwelling Urethral Foley Catheter Following Bulbar Urethroplasty: A Pragmatic Multi-Institutional Randomized Controlled Non-Inferiority Trial
The goal of this clinical trial is to learn when is the best time to remove a Foley catheter (tube used to drain urine from the bladder) after surgery in adult men who have a specific type of urethral stricture disease (narrowing of the tube that carries urine from the body). The main question it aims to answer is:
- Is there a difference between removing the catheter at 7-10 days versus 18-21 days?
Read more
Researchers will compare Foley removal at 7-10 days to removal at 18-21 days to see if there is a difference in problems after surgery or if the narrowing returns.
Participants will:
- Complete a survey before surgery, when the catheter is removed, and within 12 months after surgery
- Complete follow-up visits after surgery based on your specific medical needs and standard of care
- Conditions
- Urethral Stricture, Bulbar
- Being tested
- Early catheter removal, Later catheter removal
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early catheter removalDevice
Removal after 7-10 days
Later catheter removalDevice
Removal after 18-21 days
| Study group | Role | What they receive |
|---|---|---|
| Early Removal | Experimental | Not described Receives: Device: Early catheter removal |
| Later Removal | Experimental | Not described Receives: Device: Later catheter removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Experience a Stricture Recurrence
Measured: 1 year
Number of Participants who Experience a Perioperative Complication
Measured: From Foley insertion to Foley removal
Secondary outcomes (1)
Rate of Retrograde Urethrograms Performed on Day of Foley Removal
Measured: Foley Removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start28 Aug 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral Stricture, BulbarStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jane Kurtzman
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor-investigator, Jane Kurtzman, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220980
- Sponsor's protocol ID
- 171398
- Status last verified
- Dec 2025
- First submitted
- 22 Oct 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Duration of Indwelling Urethral Foley Catheter Following Bulbar Urethroplasty: A Pragmatic Multi-Institutional Randomized Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07220980
- Acronym / sponsor ID
- 171398
- Conditions
- Urethral Stricture, Bulbar
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Jane KurtzmanUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 Oct 2025 (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.
The goal of this clinical trial is to learn when is the best time to remove a Foley catheter (tube used to drain urine from the bladder) after surgery in adult men who have a specific type of urethral stricture disease (narrowing of the tube that carries urine from the body). The main question it aims to answer is:
- Is there a difference between removing the catheter at 7-10 days versus 18-21 days?
Researchers will compare Foley removal at 7-10 days to removal at 18-21 days to see if there is a difference in problems after surgery or if the narrowing returns.
Participants will:
- Complete a survey before surgery, when the catheter is removed, and within 12 months after surgery
- Complete follow-up visits after surgery based on your specific medical needs and standard of care
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Removal | Experimental | Device: Early catheter removal |
| Later Removal | Experimental | Device: Later catheter removal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cis-male patients
- Age 18-70, inclusive
- Bulbar urethral stricture undergoing a urethroplasty
- Urethral stricture defect less than or equal to 7cm in length
- First time urethroplasty
Key exclusion criteria (5 listed)
- History of pelvic radiation
- Diabetes with Hba1c greater than 8%
- Penile urethral stricture
- Posterior urethroplasty
- Bulbar stricture greater than 7cm
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 |
|---|---|---|
| Early catheter removalRemoval after 7-10 days | Device | Early Removal |
| Later catheter removalRemoval after 18-21 days | Device | Later Removal |
Primary outcome
Number of Participants who Experience a Stricture Recurrence
Time frame: 1 year
Number of Participants who Experience a Perioperative Complication
Time frame: From Foley insertion to Foley removal
1 secondary outcome
Rate of Retrograde Urethrograms Performed on Day of Foley Removal
Time frame: Foley Removal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early catheter removal and Later catheter removal in people with Urethral Stricture, Bulbar, run by Jane Kurtzman at 4 sites in United States.
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 6 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Experience a Stricture Recurrence (time frame: 1 year). 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 27 Feb 2026.