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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Profilometry
Sponsored by
Clinical Hospital Centre Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Incontinence focused on measuring Urinary Incontinence, Radical Prostatectomy, Urethral Pressure Profile, ICIQ-UI SF, Pads

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UHC Zagreb

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with prostate cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2022
Last Updated
February 15, 2022
Sponsor
Clinical Hospital Centre Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT05247775
Brief Title
Urethral Functional Profile Length Before Radical Prostatectomy as an Early Postoperative Continence Predictor
Official Title
Urethral Functional Profile Length Before Radical Prostatectomy as an Early Postoperative Continence Predictor
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
May 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Hospital Centre Zagreb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Urinary Incontinence, Radical Prostatectomy, Urethral Pressure Profile, ICIQ-UI SF, Pads

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with prostate cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Profilometry
Other Intervention Name(s)
Urethral pressure profile measurement
Intervention Description
Profilometry was performed in 43 patients before open retropubic radical prostatectomy.
Primary Outcome Measure Information:
Title
Functional Urethral Length as a predictor of Urinary Incontinence
Description
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.
Time Frame
24 weeks
Title
Maximum Urethral Closure Pressure as a predictor of Urinary Incontinence
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Patients enrolled in the study have prostate cancer.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirko Bakula
Organizational Affiliation
Clinical Hospital Centre Zagreb
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHC Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD that underlie results in a publication (Urethral Pressure Profilometry results, ICIQ-UI SF scoring charts and urinary pads usage) will be available upon the request to Principal Investigator
Citations:
PubMed Identifier
35670263
Citation
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.
Results Reference
derived

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

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