Evaluation of the Effect of Endoscopic Urethral Procedures Applied After Radical Prostatectomy on Urinary Incontinence

Not Applicable

Completed

• Conditions: Incontinence; Prostate Cancer
• Interventions: Procedure: endoscopic surgical intervention

• Registration Number: NCT04924218
• Lead Sponsor: Ankara Yildirim Beyazıt University

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.

Study Timeline

• Study Start: 2020-11-15
• Primary Completion: 2021-05-26
• Study Completion: 2021-05-26
• Status Verified: 2021-06
• Study First Submitted: 2021-06-06
• Study First Submitted QC: 2021-06-10
• Last Update Submitted: 2021-06-10
• Study First Posted: 2021-06-11
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
flexible cystoscopy	endoscopic surgical intervention	Group undergoing endoscopic urethral procedure with flexible cystoscopy after radical prostatectomy
rigid cystoscopy	endoscopic surgical intervention	Group undergoing endoscopic urethral procedure with rigid cystoscopy after radical prostatectomy
semi-rigid ureterorenoscopy	endoscopic surgical intervention	Group undergoing endoscopic urethral procedure with semi-rigid ureterorenoscopy after radical prostatectomy

Primary Outcome Measures

Name	Time	Method
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)	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	1 month	It refers to the number of pads used in 1 day due to urinary incontinence.

Trial Locations

Locations (1)

Ankara Yildirim Beyazit University, Schhol of Medicine; 🇹🇷 Ankara, Turkey