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

NCT ID: NCT05247775

Last Updated: 2022-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2021-05-07

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.

Detailed Description

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Patients with prostate cancer

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.

Group Type EXPERIMENTAL

Profilometry

Intervention Type PROCEDURE

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

Interventions

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Profilometry

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

Intervention Type PROCEDURE

Other Intervention Names

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Urethral pressure profile measurement

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Clinical Hospital Centre Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Mirko Bakula

Urology specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mirko Bakula

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital Centre Zagreb

Locations

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UHC Zagreb

Zagreb, , Croatia

Site Status

Countries

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Croatia

References

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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.

Reference Type DERIVED
PMID: 35670263 (View on PubMed)

Other Identifiers

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25062009

Identifier Type: -

Identifier Source: org_study_id

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