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

Sponsor
Ankara Yildirim Beyazıt University (Other)
Overall Status
Completed
CT.gov ID
NCT04924218
Collaborator
(none)
18
1
3
6.3
2.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: endoscopic surgical intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of Endoscopic Procedures After Radical Prostatectomy on Urinary Incontinence
Actual Study Start Date :
Nov 15, 2020
Actual Primary Completion Date :
May 26, 2021
Actual Study Completion Date :
May 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: rigid cystoscopy

Group undergoing endoscopic urethral procedure with rigid cystoscopy after radical prostatectomy

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.

Active Comparator: flexible cystoscopy

Group undergoing endoscopic urethral procedure with flexible cystoscopy after radical prostatectomy

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.

Active Comparator: semi-rigid ureterorenoscopy

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Daily pad use [1 month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
52 Years to 84 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara Yildirim Beyazit University, Schhol of Medicine Ankara Turkey 06800

Sponsors and Collaborators

  • Ankara Yildirim Beyazıt University

Investigators

  • Study Chair: Onder Kayigil, Professor, Ankara Yildirim Beyazit University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
selman unal, Principal Investigator, Ankara Yildirim Beyazıt University
ClinicalTrials.gov Identifier:
NCT04924218
Other Study ID Numbers:
  • AnkaraYBU-URO-SU-01
First Posted:
Jun 11, 2021
Last Update Posted:
Jun 11, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by selman unal, Principal Investigator, Ankara Yildirim Beyazıt University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 11, 2021