Clinical trial NCT04924218: Evaluation of the Effect of Endoscopic Urethral Procedures Applied After Radical Prostatectomy on Urinary Incontinence
Official title: The Effect of Endoscopic Procedures After Radical Prostatectomy on Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Incontinence
Keywords: Prostate Cancer
Urinary Incontinence
Endoscopic Surgical Procedures
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 18
Sex: MALE
Minimum age (years): 52
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone radical prostatectomy
* Patients that had undergone an endoscopic procedure 1 year after RP

Exclusion Criteria:

* 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

Primary outcomes:
measure: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
timeFrame: 1 month
measure: Daily pad use
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit University, Schhol of Medicine
Study officials:
affiliation: Ankara Yildirim Beyazit University School of Medicine
name: Onder Kayigil, Professor
role: STUDY_CHAIR
References: