RecurrenceNCT05069883
Role of Oral Steroids in Reducing Recurrence of Urethral Stricture After Direct Vision Internal Urethrotomy
A study testing Steroid Drug and No steroid in people with Recurrence, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial summary
It was a randomized controlled trial conducted at department of Urology, Armed Forces Institute of Urology, Rawalpindi from 1st January, 2018 July 2019 to 31st March 2021 to determine the role of oral steroids after Direct Vision Internal Urethrotomy to reduce the recurrence rate of urethral strictures. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Recurrence
- What is being tested?
- Steroid Drug and No steroid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2018to 31 Mar 2021
- 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 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with urethral stricture with restricted urine flow of < 15 ml/min on uroflowmetry
Who cannot join
- Patients presenting with post-anastomotic urethroplasty strictures (assessed on history and medical record),
- Patients with post-TURP strictures
- Patients with neurogenic bladder
- Patients with prior history of steroid use
- Patients with extravasation during optical internal urethrotomy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed Force Institute of Urology
Rawalpindi, Punjab Province, 54000
About this study
It was a randomized controlled trial conducted at department of Urology, Armed Forces Institute of Urology, Rawalpindi from 1st January, 2018 July 2019 to 31st March 2021 to determine the role of oral steroids after Direct Vision Internal Urethrotomy to reduce the recurrence rate of urethral strictures.
- Conditions
- Recurrence
- Being tested
- Steroid Drug, No steroid
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid DrugDrug
Also called Oral steroid medication
In this group Oral steroid medication after Direct Vision Internal Urethrotomy
No steroidDrug
Also called Placebo Medication
In this group no Oral steroid medication (palcebo medication) after Direct Vision Internal Urethrotomy
| Study group | Role | What they receive |
|---|---|---|
| Oral Steroid | Experimental | In this group oral steroids were given after Direct vision internal urethrotomy Receives: Drug: Steroid Drug |
| No Oral Steroids | Placebo comparator | In this group no oral steroids were given after Direct vision internal urethrotomy Receives: Drug: No steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Urethral Stricture
Number of patients presenting with recurrence of urethral stricture after direct vision internal urethrotomy
Measured: 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Jan 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecurrenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Collaborators
- Armed Forces Institute of Urology, Rawalpindi
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
- Investigators
- Barza Afzal, MBBS, FCPS, Study director, barza_afzal@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069883
- Sponsor's protocol ID
- AF1
- Status last verified
- Mar 2021
- First submitted
- 26 Sep 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Oral Steroids in Reducing Recurrence of Urethral Stricture After Direct Vision Internal Urethrotomy
- ClinicalTrials.gov ID
- NCT05069883
- Acronym / sponsor ID
- AF1
- Conditions
- Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Collaborators
- Armed Forces Institute of Urology, Rawalpindi
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 6 Oct 2021 (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.
It was a randomized controlled trial conducted at department of Urology, Armed Forces Institute of Urology, Rawalpindi from 1st January, 2018 July 2019 to 31st March 2021 to determine the role of oral steroids after Direct Vision Internal Urethrotomy to reduce the recurrence rate of urethral strictures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Steroid | Experimental | Drug: Steroid DrugIn this group oral steroids were given after Direct vision internal urethrotomy |
| No Oral Steroids | Placebo comparator | Drug: No steroidIn this group no oral steroids were given after Direct vision internal urethrotomy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with urethral stricture with restricted urine flow of < 15 ml/min on uroflowmetry
Key exclusion criteria (5 listed)
- Patients presenting with post-anastomotic urethroplasty strictures (assessed on history and medical record),
- Patients with post-TURP strictures
- Patients with neurogenic bladder
- Patients with prior history of steroid use
- Patients with extravasation during optical internal urethrotomy
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 |
|---|---|---|
| Steroid DrugAlso: Oral steroid medicationIn this group Oral steroid medication after Direct Vision Internal Urethrotomy | Drug | Oral Steroid |
| No steroidAlso: Placebo MedicationIn this group no Oral steroid medication (palcebo medication) after Direct Vision Internal Urethrotomy | Drug | No Oral Steroids |
Primary outcome
Recurrence of Urethral Stricture
Time frame: 6 months post-operatively
Number of patients presenting with recurrence of urethral stricture after direct vision internal urethrotomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Barza Afzal, MBBS, FCPS study director
barza_afzal@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steroid Drug and No steroid in people with Recurrence, run by Services Hospital, Lahore at 1 site in Pakistan.
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 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: finished, as of the sponsor's last update on 6 Oct 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrence of Urethral Stricture (time frame: 6 months post-operatively). 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 6 Oct 2021.