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

NCT05247775 | Completed

• 1 other identifier: 25062009
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Urinary Incontinence; Radical Prostatectomy; Urethral Pressure Profile; ICIQ-UI SF; Pads

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Patients with prostate cancer

EXPERIMENTAL

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

Interventions

Profilometry PROCEDURE

Profilometry was performed in 43 patients before open retropubic radical prostatectomy.

Also known as: Urethral pressure profile measurement

Patients with prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients enrolled in the study have prostate cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb: lead

Study Sites (1)

UHC Zagreb

Zagreb, 10000, Croatia

Location

Related Publications (1)

• Bakula M, Hudolin T, Kolar Mitrovic H, Kastelan Z. Urethral pressure profile before radical prostatectomy as a predictor of early postoperative continence. Neurourol Urodyn. 2022 Aug;41(6):1431-1439. doi: 10.1002/nau.24978. Epub 2022 Jun 7.

  PMID: 35670263 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mirko Bakula

  Clinical Hospital Centre Zagreb

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology specialist

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 21, 2022
• Study Start: July 15, 2019
• Primary Completion: November 1, 2020
• Study Completion: May 7, 2021
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)