Prostate CancerNCT04924218
Evaluation of the Effect of Endoscopic Urethral Procedures Applied After Radical Prostatectomy on Urinary Incontinence
A study testing endoscopic surgical intervention in people with Prostate Cancer and Incontinence, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The researchers investigated whether endoscopic retrograde urethral interventions applied for various reasons after radical prostatectomy (RP) operation cause a change in urinary incontinence (UI) level, and if there is a change, whether it changes according to the endoscopic procedure time and the endoscopic… Read more about this study
- Who is it for?
- Ages 52 to 84 years, men only
- Conditions the study is for
- Prostate Cancer, Incontinence
- What is being tested?
- endoscopic surgical intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2020to 26 May 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 52 to 84 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone radical prostatectomy
- Patients that had undergone an endoscopic procedure 1 year after RP
Who cannot join
- Patients with urinary tract infection before the endoscopic procedure,
- Urinary tract infection at 1st month follow-up
- Central neurological deficit
- History of adjuvant radiotherapy after RP
- Bladder neck stenosis and urethral stenosis
- Patients that had undergone endoscopic urethral intervention before this scheduled procedure
- Patients who had a double J stent inserted during the endoscopic procedure and required a second endoscopic intervention
- Patients that required the use of bipolar or monopolar cautery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yildirim Beyazit University, Schhol of Medicine
Ankara, 06800
About this study
Official title: The Effect of Endoscopic Procedures After Radical Prostatectomy on Urinary Incontinence
The researchers investigated whether endoscopic retrograde urethral interventions applied for various reasons after radical prostatectomy (RP) operation cause a change in urinary incontinence (UI) level, and if there is a change, whether it changes according to the endoscopic procedure time and the endoscopic instrument used.
Read the detailed description
Localized prostate cancer is usually treated with RP. The most common complications after RP are erectile dysfunction (ED) and UI. After RP, some patients may require retrograde endoscopic urethral intervention. In this study, researchers investigated whether there is a change in the UI level in patients that underwent retrograde urethral intervention after RP and whether this change was affected by the duration of the procedure and type of endoscopic device used.
Methods: Eighteen patients were included in the study. The patients were divided into 3 groups based on the endoscopic device used: group 1 rigid cystoscopy, group 2 flexible cystoscopy, and group 3 semi-rigid ureterorenoscopy (URS). The Turkish version of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) and the number of pads used daily was questioned before the endoscopic procedure and 1 month after the procedure.
- Conditions
- Prostate Cancer, Incontinence
- Being tested
- endoscopic surgical intervention
- Keywords
- Prostate Cancer, Urinary Incontinence, Endoscopic Surgical Procedures
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic surgical interventionProcedure or surgery
The researchers investigated whether endoscopic surgical procedures performed due to various indications (hematuria, urinary tract stone, suspected bladder mass) in the patient group who had undergone radical prostatectomy, caused a change in urinary incontinence level. The researchers divided the endoscopic instruments used into 3 groups and evaluated whether there was a difference in urinary incontinence level between rigid cystoscope, flexible cystoscope and ureterorenoscope groups.
| Study group | Role | What they receive |
|---|---|---|
| rigid cystoscopy | Active comparator | Group undergoing endoscopic urethral procedure with rigid cystoscopy after radical prostatectomy Receives: Procedure: endoscopic surgical intervention |
| flexible cystoscopy | Active comparator | Group undergoing endoscopic urethral procedure with flexible cystoscopy after radical prostatectomy Receives: Procedure: endoscopic surgical intervention |
| semi-rigid ureterorenoscopy | Active comparator | Group undergoing endoscopic urethral procedure with semi-rigid ureterorenoscopy after radical prostatectomy Receives: Procedure: endoscopic surgical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. Minimum score: 0, maximum score: 21. The higher the score, the higher the level of urinary incontinence is interpreted.
Measured: 1 month
Daily pad use
It refers to the number of pads used in 1 day due to urinary incontinence.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start15 Nov 2020
- Primary completion26 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, selman unal, Ankara Yildirim Beyazıt University
- Investigators
- Onder Kayigil, Professor, Study chair, Ankara Yildirim Beyazit University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924218
- Sponsor's protocol ID
- AnkaraYBU-URO-SU-01
- Status last verified
- Jun 2021
- First submitted
- 6 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Endoscopic Procedures After Radical Prostatectomy on Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04924218
- Acronym / sponsor ID
- AnkaraYBU-URO-SU-01
- Conditions
- Prostate Cancer, Incontinence
- Keywords
- Prostate Cancer, Urinary Incontinence, Endoscopic Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 11 Jun 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.
The researchers investigated whether endoscopic retrograde urethral interventions applied for various reasons after radical prostatectomy (RP) operation cause a change in urinary incontinence (UI) level, and if there is a change, whether it changes according to the endoscopic procedure time and the endoscopic instrument used.
Detailed description
Localized prostate cancer is usually treated with RP. The most common complications after RP are erectile dysfunction (ED) and UI. After RP, some patients may require retrograde endoscopic urethral intervention. In this study, researchers investigated whether there is a change in the UI level in patients that underwent retrograde urethral intervention after RP and whether this change was affected by the duration of the procedure and type of endoscopic device used.
Methods: Eighteen patients were included in the study. The patients were divided into 3 groups based on the endoscopic device used: group 1 rigid cystoscopy, group 2 flexible cystoscopy, and group 3 semi-rigid ureterorenoscopy (URS). The Turkish version of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) and the number of pads used daily was questioned before the endoscopic procedure and 1 month after the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rigid cystoscopy | Active comparator | Procedure: endoscopic surgical interventionGroup undergoing endoscopic urethral procedure with rigid cystoscopy after radical prostatectomy |
| flexible cystoscopy | Active comparator | Procedure: endoscopic surgical interventionGroup undergoing endoscopic urethral procedure with flexible cystoscopy after radical prostatectomy |
| semi-rigid ureterorenoscopy | Active comparator | Procedure: endoscopic surgical interventionGroup undergoing endoscopic urethral procedure with semi-rigid ureterorenoscopy after radical prostatectomy |
Who may qualify
- Ages
- 52 to 84 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have undergone radical prostatectomy
- Patients that had undergone an endoscopic procedure 1 year after RP
Key exclusion criteria (8 listed)
- Patients with urinary tract infection before the endoscopic procedure,
- Urinary tract infection at 1st month follow-up
- Central neurological deficit
- History of adjuvant radiotherapy after RP
- Bladder neck stenosis and urethral stenosis
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 |
|---|---|---|
| endoscopic surgical interventionThe researchers investigated whether endoscopic surgical procedures performed due to various indications (hematuria, urinary tract stone, suspected bladder mass) in the patient group who had undergone radical prostatectomy, caused a change in urinary incontinence level. The researchers divided the endoscopic instruments used into 3 groups and evaluated whether there was a difference in urinary incontinence level between rigid cystoscope, flexible cystoscope and ureterorenoscope groups. | Procedure or surgery | flexible cystoscopy, rigid cystoscopy, semi-rigid ureterorenoscopy |
Primary outcome
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
Time frame: 1 month
The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. Minimum score: 0, maximum score: 21. The higher the score, the higher the level of urinary incontinence is interpreted.
Daily pad use
Time frame: 1 month
It refers to the number of pads used in 1 day due to urinary incontinence.
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 11 Jun 2021.
- 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. This study is not recruiting at the moment.
Onder Kayigil, Professor study chair
Ankara Yildirim Beyazit University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic surgical intervention in people with Prostate Cancer and Incontinence, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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 2 inclusion and 8 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 11 Jun 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 Turkey (Türkiye). 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?
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?
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) (time frame: 1 month). 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 11 Jun 2021.