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

NCT04924218 | Completed

• 1 other identifier: AnkaraYBU-URO-SU-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Incontinence

Keywords

Prostate Cancer; Urinary Incontinence; Endoscopic Surgical Procedures

Outcome Measures

Primary Outcomes (2)

• 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

• Daily pad use

  It refers to the number of pads used in 1 day due to urinary incontinence.

  1 month

Study Arms (3)

rigid cystoscopy

ACTIVE COMPARATOR

Group undergoing endoscopic urethral procedure with rigid cystoscopy after radical prostatectomy

Procedure: endoscopic surgical intervention

flexible cystoscopy

ACTIVE COMPARATOR

Group undergoing endoscopic urethral procedure with flexible cystoscopy after radical prostatectomy

Procedure: endoscopic surgical intervention

semi-rigid ureterorenoscopy

ACTIVE COMPARATOR

Group undergoing endoscopic urethral procedure with semi-rigid ureterorenoscopy after radical prostatectomy

Procedure: endoscopic surgical intervention

Interventions

endoscopic surgical intervention PROCEDURE

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.

flexible cystoscopy; rigid cystoscopy; semi-rigid ureterorenoscopy

Eligibility Criteria

• Age: 52 Years - 84 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yildirim Beyazit University, Schhol of Medicine

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Onder Kayigil, Professor

  Ankara Yildirim Beyazit University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 11, 2021
• Study Start: November 15, 2020
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)