AzTrials
AzTrials

Urinary Incontinence, StressNCT02901392

Fundación IVO Registry for Patients Undergoing Sling or Artificial Urinary Sphincter After Prostate Cancer Treatment

An observational study of Urinary Incontinence, Stress, run by Fundación Instituto Valenciano de Oncología at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Stress urinary incontinence is a significant potential source of morbidity after radical prostatectomy or radiation therapy for prostate cancer. At present, artificial urinary sphincter remains the preferred therapeutic option. However, this technique is not free from complications. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Urinary Incontinence, Stress
What is being tested?
AMS-800, ADVANCE/ADVANCEXP and VIRTUE
Type of treatment
Surgery or procedure
How many people
400 participants
Where
1 siteSpain
Study dates
Apr 2004to Apr 2031
How long will I take part?
15 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with stress urianry incontinence undergoing male sling or artificial urinary sphincter after prostatectomy or radiation therapy for prostate cancer

Who may be able to join

  • The subject has agreed to be treated with the male Incontinence surgery devices
  • The subject is willing and able to give valid informed consent.
  • The subject is > 18 years of age.
  • The subject has confirmed stress urinary incontinence for at least 12 months after prostatectomy or radiotherapy.
  • It has been confirmed the stress urinary incontinence with 24-Hour Pad Weight test
  • Pre-operative urodynamic assessment and flexible cystoscopy were performed in all cases
  • The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
  • There are no surgical contraindications.

Who cannot join

  • The subject has an active urinary tract infection or active skin infection in region of surgery
  • The subject has serious bleeding disorders
  • The subject has unstable bladder neck stricture disease
  • The subject has Neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
  • The subject has Detrusor-external sphincter dyssynergia.
  • The subject is unable or unwilling to sign the informed consent form (ICF)and/or comply with all follow-up requirements according to the study protocol
Show all 11Show fewer
  • The subject is likely to undergo radiation therapy within the next 6 months
  • The subject has a history of connective tissue or autoimmune conditions.
  • The subject has a compromised immune system.
  • The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
  • The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Argimiro Collado, MD, PhD contact

0034961114030 ext. 4030

argicollado@gmail.com

Spain1 site, 1 recruiting

  • Argimiro Collado

    Valencia, 46009

    Argimiro Collado, MD,PhD, 0034961114030

    Recruiting

Other trials in Spain

About this study

Official title: Fundación Instituto Valenciano de Oncología Prospective Registry for Patients Undergoing Male Sling or Artificial Urinary Sphincter After Prostatectomy or Radiation Therapy for Prostate Cancer.

Stress urinary incontinence is a significant potential source of morbidity after radical prostatectomy or radiation therapy for prostate cancer. At present, artificial urinary sphincter remains the preferred therapeutic option. However, this technique is not free from complications. In an attempt to avoid such complications, male sling has been suggested for use in patients with mild degrees of stress incontinence.

Read the detailed description

This is a prospective collection of pre-defined parameters on the treatment of male stress urinary incontinence by male sling or artificial urinary sphincter.

This registry includes:

  1. Pre-operative urodynamic assessment, cystoscopy and other preoperative clinical parameters (i.e. age, body mass index, bladder neck contracture treated, urgency, 24h-PW, cystometry and pressure/flow, repositioning test)
  2. Description of surgical technique
  3. Continence is evaluated 3 months after surgery, avoiding the potential confounding impact of the initial tissue edema (Cure was defined as no pad use, and all other cases were defined as failures)
  4. Evaluation of long term functional outcome (efficacy, late complications and the loss of continence)

Surgery is performed with:

Device: Virtue® Device: Advance® and AdvanceXP® Device: Artificial urinary sphincter AMS-800® Device: Invance® Male Incontinence Sling

A prospective functional follow-up, with 24h-Pad Weight test and ICIQ-UI SF, is carried out 3-monthly for the first year and 6-monthly thereafter, parallel to the oncological follow-up.

Being tested
AMS-800, ADVANCE/ADVANCEXP, VIRTUE, INVANCE
Keywords
Male Urethral Slings, Artificial Urinary Sphincter, Prostatectomy, Radiotherapy
Medical subject headings
Urinary Incontinence, Stress

What participants receive

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

  • AMS-800Procedure or surgery

    Artificial urianry sphincter

  • ADVANCE/ADVANCEXPProcedure or surgery

    Male sling

  • VIRTUEProcedure or surgery

    Male sling

  • INVANCEProcedure or surgery

    Male sling

Study groups in NCT02901392
Study groupRoleWhat they receive
Artificial urinary sphincter AMS-800®Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with AMS-800®
Receives: Procedure: AMS-800
AdVance/AdvanceXP®Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with AdVance/AdvanceXP®
Receives: Procedure: ADVANCE/ADVANCEXP
VIRTUE®Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with VIRTUE®
Receives: Procedure: VIRTUE
INVANCE®Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with INVANCE®
Receives: Procedure: INVANCE

What is being measured

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

  1. Success rate

    Cure is defined as no pad use

    Measured: 3 months

Secondary outcomes (3)

  1. Continence improvement

    Assessed by means of the 24-Hour Pad Weight test

    Measured: 15 years

  2. Lower tract urinary symptoms modification after male surgery incontinence

    Assessed with IPSS questionaires

    Measured: 15 years

  3. Quality of Life in patients with male surgery incontinence

    Assessed with "International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)" questionaires

    Measured: 15 years

Timeline

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

  1. First posted15 Sep 2016 (estimated)
  2. Study startApr 2004
  3. Primary completionApr 2019 (estimated)
  4. Study completionApr 2031 (estimated)

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
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
Target duration
15 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02901392
Sponsor's protocol ID
Oncodinamia01
Status last verified
Jul 2018
First submitted
12 Sep 2016
Last updated
2 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Collado A, Gomez-Ferrer A, Rubio-Briones J, Bonillo MA, Iborra I, Solsona E. [Which patients with stress urinary incontinence after radical prostatectomy benefit from the indication of an Invance?]. Arch Esp Urol. 2009 Dec;62(10):851-9. doi: 10.4321/s0004-06142009001000010. Spanish.

    PubMed 20065535

  • Collado Serra A, Resel Folkersma L, Dominguez-Escrig JL, Gomez-Ferrer A, Rubio-Briones J, Solsona Narbon E. AdVance/AdVance XP transobturator male slings: preoperative degree of incontinence as predictor of surgical outcome. Urology. 2013 May;81(5):1034-9. doi: 10.1016/j.urology.2013.01.007. Epub 2013 Mar 7.

    PubMed 23465151

  • Collado Serra A, Dominguez-Escrig J, Gomez-Ferrer A, Batista Miranda E, Rubio-Briones J, Solsona Narbon E. Prospective follow-up study of artificial urinary sphincter placement preserving the bulbospongiosus muscle. Neurourol Urodyn. 2017 Jun;36(5):1387-1394. doi: 10.1002/nau.23119. Epub 2016 Sep 21.

    PubMed 27654121

  • Collado A, Dominguez-Escrig J, Ortiz Rodriguez IM, Ramirez-Backhaus M, Rodriguez Torreblanca C, Rubio-Briones J. Functional follow-up after Advance(R) and Advance XP(R) male sling surgery: assessment of predictive factors. World J Urol. 2019 Jan;37(1):195-200. doi: 10.1007/s00345-018-2357-9. Epub 2018 Jun 8.

    PubMed 29948042

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Incontinence, Stress, run by Fundación Instituto Valenciano de Oncología at 1 site in Spain.

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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Argimiro Collado, MD, PhD (0034961114030 ext. 4030, argicollado@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02901392, which also lists 4 linked publications.

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 2 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in