Pressure-Volume Measurements on the AMS 800TM Cuff

NCT03122392 | Completed FDA Device

• 1 other identifier: 1703M09441
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

he idea of the experiment is to calculate the volume of fluid that is required to raise cuff pressure from 20 cmH2O to 120 cmH2O in the American Medical System's AMS 800 Artificial Urinary Sphincter (AUS).

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Pressure-Volume Measurements on the AMS 800TM Cuff

  Measure volume and corresponding pressure in AMS 800TM occlusion Cuff

  6 months

Study Arms (1)

AMS 800 Artificial Urinary Sphincter

EXPERIMENTAL

The AMS 800™ Urinary Control System is an implantable, fluid-filled, solid silicone elastomer prosthesis used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800 Urinary Control System simulates normal sphincter function by opening and closing the urethra, under patient control. When the cuff is closed, urine stays in the bladder. When the patient wishes to void, he simply squeezes and releases the pump several times. This causes the fluid in the cuff to move into the pressure-regulating balloon . The cuff opens and urine passes through the urethra. The balloon then automatically re-pressurizes the cuff through the pump, within several minutes, the cuff again closes the urethra. The control pump, which in implanted in the scrotum, is also designed to allow the clinician or patient to deactivate and activate the system without additional surgery.

Device: AMS 800

Interventions

AMS 800 DEVICE

AMS 800 Artificial Urinary Sphincter

AMS 800 Artificial Urinary Sphincter

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men between 18 and 100 years of age who are to undergo AUS placement for treatment of stress urinary incontinence.

You may not qualify if:

• Under the age of 18 years old English non-speaking Unable to consent for themselves If a trans-corporal technique to AUS implantation is planned as this may affect the pressure measurements (\<10% of the AUSs we implant are transcorporal).

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sean Elliot, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Volume and Pressure Profiles in the AMS 800 cuff. The cuff is filled with deionized water and the amount of fluid in it decides the pressure it will apply while wrapped around the urethra. The pressure-volume profiles will be taken from 6 patients consented by the PI and these will be used for the secondary end point.

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 20, 2017
• Study Start: June 28, 2017
• Primary Completion: February 7, 2018
• Study Completion: March 1, 2018
• Last Updated: July 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)