Urethral Functional Profile Length Before Radical Prostatectomy as an Early Postoperative Continence Predictor

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Procedure: Profilometry

• Registration Number: NCT05247775
• Lead Sponsor: Clinical Hospital Centre Zagreb

Brief Summary

Urinary incontinence (UI) is one of the most common complications of radical prostatectomy (RP). Impaired urethral sphincter function is generally considered to be the most important contributing factor of UI however, the mechanism of onset and recovery of urinary continence has not been fully elucidated. In this research, the urodynamic method of Urethral Pressure Profile (UPP) was used to evaluate Functional Urethral Length (FUL) and Maximal Urethral Closure Pressure (MUCP) and correlate with the postprostatectomy continence recovery. Objective of this research is to evaluate preoperative FUL and MUCP as an early continence recovery predictors after open retropubic RP (ORRP).

The research was conducted at the Department of Urology of the University Hospital Centre Zagreb on a group of 43 patients in the period from July 15th , 2019 to May 07th , 2021.The severity of UI and bothersome were assessed using fully validated International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) and number of pads used in 24h. Patients were interviewed about the use of urinary pads and asked to fill out the ICIQ-UI SF before and 2, 8, 16 and 24 weeks after RP.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-15
• Primary Completion: 2020-11-01
• Study Completion: 2021-05-07
• Status Verified: 2022-02
• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-15
• Last Update Submitted: 2022-02-15
• Study First Posted: 2022-02-21
• Last Update Posted: 2022-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

Inclusion Criteria

1. Patients diagnosed with localized prostate cancer
2. Open Retropubic Radical Prostatectomy (ORRP) is planned as a treatment

Exclusion Criteria

1. Incontinent patients prior to ORRP
2. Previous surgery in the area of the prostatic urethra
3. Previous procedures that can damage the innervation of the pelvis
4. Radiotherapy performed in the pelvic area prior to ORRP
5. Adjuvant radiotherapy in the first postoperative year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with prostate cancer	Profilometry	We performed urethral pressure profilometry prior to open retropubic radical prostatectomy (ORRP). Patients were interviewed about the urinary incontinence by the usage of pads and International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) prior to ORRP and at 2, 8, 16 and 24 weeks after ORRP.

Primary Outcome Measures

Name	Time	Method
Functional Urethral Length as a predictor of Urinary Incontinence	24 weeks	Functional Urethral Length (FUL) is measured using Urethral Presssure Profilometry and expressed in mm. The severity of urinary incontinence and bothersome were assessed using fully validated International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) and number of pads used in 24h. Patients were interviewed about the use of urinary pads and asked to fill out the ICIQ-UI SF before and 2, 8, 16 and 24 weeks after radical prostatectomy. ICIQ-UI SF score ranges: min 0, max 21 (higher score indicating greater severity of symptoms). Cut-off for positive UI, in this research, was 6. Cut-off for positive UI by number of pads used per day was 2.
Maximum Urethral Closure Pressure as a predictor of Urinary Incontinence	24 weeks	Maximum Urethral Closure Pressure (MUCP) is measured using Urethral Presssure Profilometry and expressed cmH2O. The severity of urinary incontinence and bothersome were assessed using fully validated International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) and number of pads used in 24h. Patients were interviewed about the use of urinary pads and asked to fill out the ICIQ-UI SF before and 2, 8, 16 and 24 weeks after radical prostatectomy. ICIQ-UI SF score ranges: min 0, max 21 (higher score indicating greater severity of symptoms). Cut-off for positive UI, in this research, was 6. Cut-off for positive UI by number of pads used per day was 2.

Trial Locations

Locations (1)

UHC Zagreb; 🇭🇷 Zagreb, Croatia