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

Primary Purpose

Prostate Cancer, Incontinence

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
endoscopic surgical intervention
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring Prostate Cancer, Urinary Incontinence, Endoscopic Surgical Procedures

Eligibility Criteria

52 Years - 84 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara Yildirim Beyazit University, Schhol of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

rigid cystoscopy

flexible cystoscopy

semi-rigid ureterorenoscopy

Arm Description

Group undergoing endoscopic urethral procedure with rigid cystoscopy after radical prostatectomy

Group undergoing endoscopic urethral procedure with flexible cystoscopy after radical prostatectomy

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 6, 2021
Last Updated
June 10, 2021
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT04924218
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
May 26, 2021 (Actual)
Study Completion Date
May 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Incontinence
Keywords
Prostate Cancer, Urinary Incontinence, Endoscopic Surgical Procedures

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rigid cystoscopy
Arm Type
Active Comparator
Arm Description
Group undergoing endoscopic urethral procedure with rigid cystoscopy after radical prostatectomy
Arm Title
flexible cystoscopy
Arm Type
Active Comparator
Arm Description
Group undergoing endoscopic urethral procedure with flexible cystoscopy after radical prostatectomy
Arm Title
semi-rigid ureterorenoscopy
Arm Type
Active Comparator
Arm Description
Group undergoing endoscopic urethral procedure with semi-rigid ureterorenoscopy after radical prostatectomy
Intervention Type
Procedure
Intervention Name(s)
endoscopic surgical intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
Description
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.
Time Frame
1 month
Title
Daily pad use
Description
It refers to the number of pads used in 1 day due to urinary incontinence.
Time Frame
1 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
52 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Onder Kayigil, Professor
Organizational Affiliation
Ankara Yildirim Beyazit University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara Yildirim Beyazit University, Schhol of Medicine
City
Ankara
ZIP/Postal Code
06800
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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