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

Prostate Cancer Clinical Trial

Official title:

The Effect of Endoscopic Procedures After Radical Prostatectomy on Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04924218
• Other study ID #: AnkaraYBU-URO-SU-01
• Status: Completed
• Phase: N/A
• Start date: November 15, 2020
• Est. completion date: May 26, 2021

Study information

• Verified date: June 2021
• Source: Ankara Yildirim Beyazit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 instrument used.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 26, 2021
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 52 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Incontinence
• Prostate Cancer
• Prostatic Neoplasms
• Urinary Incontinence

Intervention

Procedure:
• endoscopic surgical intervention
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.

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit University, Schhol of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Primary	Daily pad use	It refers to the number of pads used in 1 day due to urinary incontinence.	1 month