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

NCT02901392 | Recruiting

• 1 other identifier: Oncodinamia01
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. In an attempt to avoid such complications, male sling has been suggested for use in patients with mild degrees of stress incontinence.

Conditions

Urinary Incontinence, Stress

Keywords

Male Urethral Slings; Artificial Urinary Sphincter; Prostatectomy; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Success rate

  Cure is defined as no pad use

  3 months

Secondary Outcomes (3)

• Continence improvement

  15 years

• Lower tract urinary symptoms modification after male surgery incontinence

  15 years

• Quality of Life in patients with male surgery incontinence

  15 years

Study Arms (4)

Artificial urinary sphincter AMS-800®

Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with AMS-800®

Procedure: AMS-800

AdVance/AdvanceXP®

Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with AdVance/AdvanceXP®

Procedure: ADVANCE/ADVANCEXP

VIRTUE®

Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with VIRTUE®

Procedure: VIRTUE

INVANCE®

Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with INVANCE®

Procedure: INVANCE

Interventions

AMS-800 PROCEDURE

Artificial urianry sphincter

Artificial urinary sphincter AMS-800®

ADVANCE/ADVANCEXP PROCEDURE

Male sling

AdVance/AdvanceXP®

VIRTUE PROCEDURE

Male sling

VIRTUE®

INVANCE PROCEDURE

Male sling

INVANCE®

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Fundación Instituto Valenciano de Oncología: lead

Study Sites (1)

Argimiro Collado

Valencia, 46009, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 20065535 RESULT

• 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.

  PMID: 23465151 RESULT

• 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.

  PMID: 27654121 RESULT

• 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.

  PMID: 29948042 RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Argimiro Collado, MD,PhD

  Fundación IVO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Argimiro Collado, MD, PhD

CONTACT

0034961114030; argicollado@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 15, 2016
• Study Start: April 1, 2004
• Primary Completion: April 1, 2019
• Study Completion (Estimated): April 1, 2031
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)