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NCT Number: NCT04924218

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

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.

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Key information

Conditions

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

Age range

52 year–84 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Yildirim Beyazit University, Schhol of Medicine

Ankara, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)

    Time frame: 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

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

The Effect of Endoscopic Procedures After Radical Prostatectomy on Urinary Incontinence

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2021
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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