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

A

Ankara Yildirim Beyazıt University

Status

Completed

Conditions

Prostate Cancer
Incontinence

Treatments

Procedure: endoscopic surgical intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04924218
AnkaraYBU-URO-SU-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

Male

Ages

52 to 84 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 3 patient groups

rigid cystoscopy
Active Comparator group
Description:
Group undergoing endoscopic urethral procedure with rigid cystoscopy after radical prostatectomy
Treatment:
Procedure: endoscopic surgical intervention
flexible cystoscopy
Active Comparator group
Description:
Group undergoing endoscopic urethral procedure with flexible cystoscopy after radical prostatectomy
Treatment:
Procedure: endoscopic surgical intervention
semi-rigid ureterorenoscopy
Active Comparator group
Description:
Group undergoing endoscopic urethral procedure with semi-rigid ureterorenoscopy after radical prostatectomy
Treatment:
Procedure: endoscopic surgical intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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