AMS AdVance and AdVance XP Male Sling Systems for the Treatment of Stress Urinary Incontinence Following Prostatectomy: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review and Prospective Follow-up

Urinary Incontinence, Stress Clinical Trial

Official title:

AMS AdVance and AdVance XP Male Sling Systems for the Treatment of Stress Urinary Incontinence Following Prostatectomy: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review and Prospective Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725984
• Other study ID #: MC1201
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2012
• Last updated: June 25, 2015
• Start date: August 2012
• Est. completion date: January 2014

Study information

• Verified date: June 2015
• Source: American Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

A single-center retrospective chart review of AdVance and AdVance XP subject data, combined with prospective follow-up of the same subjects to confirm continence, adverse event, and quality of life status. This study includes patients previously implanted with an AdVance or AdVance XP male sling.

Description:

A single-center retrospective chart review of AdVance and AdVance XP subject data, combined with prospective follow-up of the same subjects to confirm continence, adverse event, and quality of life status. This study includes patients previously implanted with an AdVance or AdVance XP male sling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Valid, written informed consent has been obtained

2. Male subject =40 years of age who received the AdVance male sling after January 1, 2010 or the AdVance XP male sling after July 1, 2010 for the treatment of post prostatectomy SUI

3. Pad use of 1 to 8 pads per day prior to sling placement (subjects who used only a dry prophylactic pad or safety liner at baseline will not be included)

4. External (distal) sphincter contractility and a coaptive zone of = 1cm confirmed by endoscopic view prior to sling placement

5. Primary etiology of SUI resulting from radical prostatectomy including, simple open prostatectomy, robotic or laparoscopic prostatectomy

Exclusion Criteria:

1. Pad use of more than 8 pads per day prior to sling placement for incontinence management

2. Urine loss while lying in bed prior to sling placement

3. Treatment with a urethral sling system, an AMS Sphincter 800®, or any implanted device for the treatment of urinary incontinence (not including bulking agents) prior to sling placement

4. TURP procedure prior to sling placement

5. Urge predominant incontinence prior to sling placement

6. Past or current neurological disorder (e.g. neurogenic bladder, multiple sclerosis, Parkinson's disease)

7. History of connective tissue or autoimmune conditions

8. Past or current condition of compromised immune system

9. Placement of an inflatable penile prosthesis (IPP) after sling placement

10. Post void residual of >50 ml prior to sling placement

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Intrinsic Sphincter Deficiency
• Urinary Incontinence
• Urinary Incontinence, Stress

Locations

Country	Name	City	State
Germany	Ludwig-Maximilians Universität (LMU)	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
American Medical Systems

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With a =50% Reduction in Pads Per Day Use	Evaluate the proportion of subjects with a =50% reduction in pads per day use	3 Months Post Procedure	No
Primary	Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use	Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and =50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit	3 months Post Procedure	No
Primary	Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use	Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit: 0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);	Baseline	No
Primary	Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit	Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.	Prospective follow-up to 36 Months Post Procedure	No
Primary	Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow.	The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100.; The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 1-21.; The Patient Global Impression of Improvement (PGI-I) questionnaire is a single question instrument that assess a subject's perception of the disease impact on their quality of life. Completed at the last visit, a lower score indicates a better perception from the patient. Scale from 1 to 7.	Baseline to Prospective Follow Up (up to 36 months)	No
Primary	Number of Adverse Events Reported Between Arms	Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events	Prospective follow-up to 36 Months Post Procedure	Yes
Primary	Percentage of Subjects With a =50% Reduction in Pads Per Day Use	Evaluate the proportion of subjects with a =50% reduction in pads per day use	Prospective follow-up to 36 Months Post Procedure	No
Primary	Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use	Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and =50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit	Prospective follow-up to 36 Months Post Procedure	No
Primary	Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use	Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit: 0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);	3 Months Post Procedure	No
Primary	Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use	Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit: 0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);	Prospective follow-up to 36 Months Post Procedure	No