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

Study Overview
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Brief Summary
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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.

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

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Procedure: Profilometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with localized prostate cancer Open Retropubic Radical Prostatectomy (ORRP) is planned as a treatment Exclusion Criteria: Incontinent patients prior to ORRP Previous surgery in the area of the prostatic urethra Previous procedures that can damage the innervation of the pelvis Radiotherapy performed in the pelvic area prior to ORRP Adjuvant radiotherapy in the first postoperative year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with prostate cancer<br>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. | Procedure: Profilometry<br>* Profilometry was performed in 43 patients before open retropubic radical prostatectomy.<br>* Other names: Urethral pressure profile measurement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Urethral Length as a predictor of Urinary Incontinence | 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. | 24 weeks | 
| Maximum Urethral Closure Pressure as a predictor of Urinary Incontinence | 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. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Radical Prostatectomy, Urethral Pressure Profile, ICIQ-UI SF, Pads