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

Recruiting

• Conditions: Urinary Incontinence, Stress
• Interventions: Procedure: AMS-800; Procedure: ADVANCE/ADVANCEXP; Procedure: VIRTUE; Procedure: INVANCE

• Registration Number: NCT02901392
• Lead Sponsor: Fundación Instituto Valenciano de Oncología

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.

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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-15
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02
• Primary Completion: 2019-04
• Study Completion: 2031-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

1. The subject has an active urinary tract infection or active skin infection in region of surgery
2. The subject has serious bleeding disorders
3. The subject has unstable bladder neck stricture disease
4. The subject has Neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
5. The subject has Detrusor-external sphincter dyssynergia.
6. 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
7. The subject is likely to undergo radiation therapy within the next 6 months
8. The subject has a history of connective tissue or autoimmune conditions.
9. The subject has a compromised immune system.
10. The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
11. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Artificial urinary sphincter AMS-800®	AMS-800	Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with AMS-800®
AdVance/AdvanceXP®	ADVANCE/ADVANCEXP	Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with AdVance/AdvanceXP®
VIRTUE®	VIRTUE	Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with VIRTUE®
INVANCE®	INVANCE	Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with INVANCE®

Primary Outcome Measures

Name	Time	Method
Success rate	3 months	Cure is defined as no pad use

Secondary Outcome Measures

Name	Time	Method
Lower tract urinary symptoms modification after male surgery incontinence	15 years	Assessed with IPSS questionaires
Quality of Life in patients with male surgery incontinence	15 years	Assessed with "International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)" questionaires
Continence improvement	15 years	Assessed by means of the 24-Hour Pad Weight test

Trial Locations

Locations (1)

Argimiro Collado; 🇪🇸 Valencia, Spain