ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence

Urinary Incontinence Clinical Trial

— SU-ACT  

Official title:

Randomised Comparative Prospective Study of the Treatment of Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency : ACT™ Balloon Versus Artificial Urinary Sphincter ( AMS800™)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02490917
• Other study ID #: P130941
• Status: Recruiting
• Phase: N/A
• First received: July 2, 2015
• Last updated: November 17, 2017
• Start date: September 2015
• Est. completion date: December 2019

Study information

• Verified date: November 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: CHARTIER-KASTLER EMMANUEL, MD, PhD
• Phone: +33(0)142177129
• Email: emmanuel.chartier-kastler[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Prospective multicenter randomized controlled trial comparing two parallel arms: the implantation of an adjustable balloon (experimental arm) versus implantation of an artificial urinary sphincter AMS800 ™ (control arm), for the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).

This research will focus on the assessment of improved continence, quality of life, and Cost-Effectiveness Analysis.

The tested device ACT ™ device is a prosthesis used to support the bladder neck and proximal urethra increasing the urethral coaptation and supporting to the bladder neck to prevent urine leakage at stress.

The medical device AMS 800 ™(control arm) is an implantable device made of silicone elastomer filled with saline/X-Ray fluid, used in the treatment of stress urinary incontinence related to ISD. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by closing the urethra and allowing the patient to void according to the patient's will and opening of the device (sub-cutaneous pump).

An inclusion visit will take place between 3 months and 1 month before the date of the surgery to explain the purpose of the study, the benefits and risks for patients, and describe the comparative medical devices.

Patients will be randomized before surgery (at D0).

The follow-up will be conducted up to one year, with scheduled visits at M1, M3, M6 and M12.

Secondary endpoints will be assessed during scheduled visits.

The medico-economic assessment will be made during the same follow-up period. This period will take into account improvement of urinary continence and results reported from the 3rd month as well as the morbidity and mortality related to the implementation of the medical device up to 1 year.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• ACT™ device
Implantation of the Adjustable Continence Therapy device ACT®
• AMS 800 ™ device
Implantation of the artificial urinary sphincter AMS 800 ™

Locations

Country	Name	City	State
France	Urology Department, Pitié-Salpêtrière University Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social continence defined by the use of 0-1 adult protective pads per day		6 months
Secondary	Assessment of incontinence (number and type of protective pads used per day)		12 months
Secondary	impact on quality of life assessed by EQ-5D Health Questionnaire.		12 months
Secondary	assessment of the urinary flow using ICIQ-FLUTS questionnaire		12 months
Secondary	Assessment of Urinary Profile Symptoms using UPS questionnaire		12 months