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

Urinary Incontinence, Stress Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02901392
• Other study ID #: Oncodinamia01
• Status: Recruiting
• Start date: April 2004
• Est. completion date: April 2031

Study information

• Verified date: July 2018
• Source: Fundación Instituto Valenciano de Oncología
• Contact: Argimiro Collado, MD, PhD
• Phone: 0034961114030
• Email: argicollado[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2031
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Prostatic Neoplasms
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• AMS-800
Artificial urianry sphincter
• ADVANCE/ADVANCEXP
Male sling
• VIRTUE
Male sling
• INVANCE
Male sling

Locations

Country	Name	City	State
Spain	Argimiro Collado	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Instituto Valenciano de Oncología

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Collado A, Domínguez-Escrig J, Ortiz Rodríguez IM, Ramirez-Backhaus M, Rodríguez Torreblanca C, Rubio-Briones J. Functional follow-up after Advance(®) and Advance XP(®) male sling surgery: assessment of predictive factors. World J Urol. 2018 Jun 8. doi: 1 — View Citation

Collado A, Gómez-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. Spanish. — View Citation

Collado Serra A, Domínguez-Escrig J, Gómez-Ferrer Á, Batista Miranda E, Rubio-Briones J, Solsona Narbón E. Prospective follow-up study of artificial urinary sphincter placement preserving the bulbospongiosus muscle. Neurourol Urodyn. 2017 Jun;36(5):1387-1 — View Citation

Collado Serra A, Resel Folkersma L, Domínguez-Escrig JL, Gómez-Ferrer A, Rubio-Briones J, Solsona Narbón E. AdVance/AdVance XP transobturator male slings: preoperative degree of incontinence as predictor of surgical outcome. Urology. 2013 May;81(5):1034-9 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	Cure is defined as no pad use	3 months
Secondary	Continence improvement	Assessed by means of the 24-Hour Pad Weight test	15 years
Secondary	Lower tract urinary symptoms modification after male surgery incontinence	Assessed with IPSS questionaires	15 years
Secondary	Quality of Life in patients with male surgery incontinence	Assessed with "International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)" questionaires	15 years