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Urinary IncontinenceNCT03097367

Predictor of Early Recovery on Urinary Continence After Laparoscopic Radical Prostatectomy

An observational study of Urinary Incontinence, run by Buddhist Tzu Chi General Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate the relationship between post-operative bladder neck levels and urodynamic parameters and their effect on urinary incontinence after laparoscopic radical prostatectomy (LRP). Forty-eight consecutive patients undergoing LRP were retrospectively reviewed. Read more about this study

Who is it for?
Ages 40 to 90 years, men only
Conditions the study is for
Urinary Incontinence
What is being tested?
bladder neck level on cystography
How many people
48 participants
Where
No sites listed yet
Study dates
Jan 2017to Mar 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive patients with localized prostate cancer underwent laparoscopic radical prostatectomy

Who may be able to join

  • Patients with localized prostate cancer underwent laparoscopic radical prostatectomy

Who cannot join

  • Patients who did not have regular follow-up after surgery

About this study

Official title: Predictor of Early Recovery on Urinary Continence After Laparoscopic Radical Prostatectomy: Bladder Neck Level and the Association With Urodynamic Parameters

To investigate the relationship between post-operative bladder neck levels and urodynamic parameters and their effect on urinary incontinence after laparoscopic radical prostatectomy (LRP). Forty-eight consecutive patients undergoing LRP were retrospectively reviewed. All patients had investigated by retrograde cystography after LRP and were grouped according their bladder neck position: Level 0: bladder neck at or above the superior margin of the symphysis pubis (SMSP), Level -1: bladder neck at <2 cm below SMSP, and Level -2: bladder neck at >2 cm below SMSP. Urodynamic studies were carried out at baseline, 3 and 6 months post-operatively. Early recovery of urinary continence was defined as no urine leakage or only one pad/day used within 3 months after surgery. Demographic characteristics, changes of urodynamic parameters and continence outcomes were analyzed.

Read the detailed description

Laparoscopic radical prostatectomy (LRP) is effective in treating localized prostate cancer with good long-term oncological outcomes. Urinary incontinence, which is a bothersome complication with a negative effect on the patient's quality of life, remains a relevant problem after LRP, despite the improvements in the surgical technique. More than 80% of patients undergoing radical prostatectomy encounter urinary incontinence immediately after catheter removal, but the bladder condition can generally stabilize within two years after operation. Among the patients undergoing LRP, persistent urinary incontinence has been reported in 4-30% of patients, and further treatment is often required.

Definite evaluation for the voiding function has been recommended for patients with prolonged post-prostatectomy urinary incontinence (PPI). To improve quality of life after LRP, early recovery of urinary continence is an important concern for patients. Several studies have investigated the predictive factors of early recovery of urinary continence after prostatectomy, including the amount of urine loss after catheter removal, pelvic floor muscle function, a nerve-sparing technique, and the membranous urethral length loss ratio.

Other factors relating to the early recovery of urinary continence include post-operative anatomy of the lower urinary tract, such as the length of the membranous urethra and the level of the vesicourethral junction. However, there has been no consensus on the standard criteria that should be used to measure the structural changes, and the relationship between the urodynamic change and the anatomical morphology remains unclear. In this study, investigators study the relationship between the urodynamic parameters and the bladder neck levels after LRP, and their effects on the early recovery of urinary incontinence.

This study was a retrospective analysis. From 2011 to 2014, a total of 48 consecutive patients with localized prostatic cancer underwent LRP in single medical center by two experienced surgeons. Videourodynamic study was performed before operation (baseline) and at 3 and 6 months after operation. The Ethics Committee of the hospital approved this study and written informed consent was waived because the study was a retrospective analysis. The principles of Helsinki Declaration were followed throughout the study.

The urodynamic parameters were measured and recorded including first sensation of filling (FSF), maximum flow rate (Qmax), detrusor pressure at Qmax (PdetQmax), voided volume, cystometric bladder capacity (CBC), bladder compliance, post-void residual (PVR) volume, maximal urethral closure pressure (MUCP) and functional profile length (FPL). The urodynamic parameters were compared between baseline and different time-points after LRP.

The BN level was evaluated by retrograde cystography, which was routinely performed 7 to 14 days after LRP to evaluate the condition of anastomosis. The image was obtained anteroposteriorly after infusing 100-150 mL of contrast solution into the bladder while the patient was in standing position. The distance between the bladder neck and the superior margin of the symphysis pubis (SMSP) was then measured by the same urologist. The bladder neck level was graded on a three-point scale: a bladder neck level at or above the SMSP was marked as level 0, a bladder neck level with a distance less than 2 cm below the SMSP was marked as level -1, and bladder neck levels 2 or more cm below the SMSP was labeled as level -2.

The patient's urinary continence status was evaluated on direct visits and via questionnaires during follow-up periods at 3, 6, and 12 months post-operatively. Patients without urine leakage in their daily life and those who used only one pad per day for safety reasons without limitation in their daily activities were defined as "urinary continent". Otherwise, the patients were defined as "urinary incontinent". Regaining continence within 3 months after LRP was considered early recovery of urinary continence.

The data was collected retrospectively by chart review. The variables among continent and incontinent patients were evaluated by univariate analysis (t-test for continuous variables and Chi-square for categorical variables ). The ANOVA test was use to compare the urodynamic parameters between different BN levels. Statistical analysis was performed using SPSS 20.0 statistical software.

Being tested
bladder neck level on cystography
Keywords
laparoscopic radical prostatectomy, urinary incontinence, prostate cancer, bladder neck level, urodynamics
Medical subject headings
Urinary Incontinence, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bladder neck level on cystographyDiagnostic test

    Also called BN level

    All patients had investigated by retrograde cystography after LRP and were grouped according their bladder neck position: Level 0: bladder neck at or above the superior margin of the symphysis pubis (SMSP), Level -1: bladder neck at <2 cm below SMSP, and Level -2: bladder neck at >2 cm below SMSP.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. urinary continence at 3 months after laparoscopic radical prostatectomy

    Patients without urine leakage in their daily life and those who used only one pad per day for safety reasons without limitation in their daily activities at 3 months after laparoscopic radical prostatectomy were defined as "urinary continent"

    Measured: from baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2017
  2. Study startJan 2017
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03097367
Sponsor's protocol ID
TCGH106-42-B
Status last verified
Mar 2017
First submitted
27 Mar 2017
Last updated
4 Apr 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share data with other researchers

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Incontinence, run by Buddhist Tzu Chi General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

urinary continence at 3 months after laparoscopic radical prostatectomy (time frame: from baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.

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