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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05247775
• Other study ID #: 25062009
• Status: Completed
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: May 7, 2021

Study information

• Verified date: February 2022
• Source: Clinical Hospital Centre Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 7, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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

Locations

Country	Name	City	State
Croatia	UHC Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Centre Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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