NCT02490917

Brief Summary

The main objective is to compare the efficacy of AMS800 ™ and ACT ™ devices for the Treatment of Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency on "social continence" at 6 months. Continence is defined by the average number of pads used per day. The social continence is defined by (0-1) pad per day

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

3 years

First QC Date

July 2, 2015

Last Update Submit

November 17, 2017

Conditions

Urinary Incontinence

Keywords

Female urinary incontinenceSphincter deficiency

Outcome Measures

Primary Outcomes (1)

  • Social continence defined by the use of 0-1 adult protective pads per day

    6 months

Secondary Outcomes (4)

  • Assessment of incontinence (number and type of protective pads used per day)

    12 months

  • impact on quality of life assessed by EQ-5D Health Questionnaire.

    12 months

  • assessment of the urinary flow using ICIQ-FLUTS questionnaire

    12 months

  • Assessment of Urinary Profile Symptoms using UPS questionnaire

    12 months

Study Arms (2)

ACT™ device

EXPERIMENTAL

Patients randomized to receive the Adjustable Continence Therapy device ACT™

Device: ACT™ device

AMS 800 ™ device

OTHER

Patients randomized to receive the artificial urinary sphincter AMS 800 ™

Device: AMS 800 ™ device

Interventions

ACT™ deviceDEVICE

Implantation of the Adjustable Continence Therapy device ACT®

ACT™ device
AMS 800 ™ deviceDEVICE

Implantation of the artificial urinary sphincter AMS 800 ™

AMS 800 ™ device

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from stress urinary incontinence due to ISD.
  • Patients with maximum urethral closure pressure(PCUM) \< 50 cm H2O or bladder leakage pressure \< 100 cm H2O
  • Patient who accepted surgery
  • Patient with normal urethra-cystoscopy (no foreign body nor calculus)
  • Patient with effort leaks on clinical examination
  • Patient who never had SUA or ACT ™ balloon
  • Affiliation to health insurance
  • Written informed consent

You may not qualify if:

  • Patient pregnant or breastfeeding
  • Patient with a life expectancy of less than 2 years
  • Patient with overactive bladder uncontrolled and considered an against-indication for surgery
  • Patient with reduced bladder compliance
  • Patient with significant post-void residual volume according to the judgment of the Investigator
  • Patient with a history of pelvic radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Department, Pitié-Salpêtrière University Hospital

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • CHARTIER-KASTLER EMMANUEL, MD, PhD

    Urology Department, Pitié-Salpêtrière University Hospital, 75013 Paris, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CHARTIER-KASTLER EMMANUEL, MD, PhD

CONTACT

+33(0)142177129emmanuel.chartier-kastler@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 7, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2018

Study Completion

December 1, 2019

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

FR(1)