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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05247775
Other study ID # 25062009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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