A Pilot Study to Evaluate Safety and Performance of Neuromuscular Electrical Stimulation With the Inko RS Device for the Treatment of Stress Urinary Incontinence

NCT01472068 | Completed Phase 1

• 1 other identifier: BMR-11-1014
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot clinical study taking place at one site in Berlin, Germany using Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of 20 women suffering from stress urinary incontinence. This involves a 12 week, 30 minute, 5 days out of 7 set treatment program with the device. After the 12 week treatment programme the subjects will be asked to perform daily set exercises for a further 14 weeks.

Conditions

Stress Urinary Incontinence

Keywords

Incontinence; NMES

Outcome Measures

Primary Outcomes (1)

• Based on a reduction in urine leakage following a standardised 1- min stress test at 1 hour post-bladder filing protocol (1-hour pad weight test) at 12 weeks compared to baseline following a 12 week treatment programme with the Inko RS Device.

  12 weeks

Secondary Outcomes (2)

• To evaluate an improvement in quality of life assessed using the Incontinence Quality of Life Questionnaire (I-QOL).

  4 wks, 8 wks and 12 weeks

• Evaluate an improvement in quality of life assessed using the Medical, Epidemiologic and Social Aspects of Aging Urinary Incontinence Questionnaire (MESA)

  at 4, 8 and 12 weeks

Study Arms (1)

Inko RS device

EXPERIMENTAL

30 minutes of treatment with the Inko RS device, five days each week, for 12 weeks.

Device: Inko RS Device

Interventions

Inko RS Device DEVICE

30 minute pre-programmed treatment for 5 days out of 7. Treatment to be carried out while standing.

Inko RS device

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are female and at least 18 years of age.
• Subject has signed informed consent form prior to any study related activity
• Subjects who have previously failed a 6 week volitional pelvic floor muscle training program.
• Subjects who have been clinically diagnosed with stress urinary incontinence and demonstrate a \>4g urine leakage following a standardised 1-minute stress test at 1 hour post-bladder filling protocol (1-hour pad weight test). Stress urinary incontinence is defined as complaint of involuntary leakage on effort or exertion, or on sneezing and coughing' (International Continence Society).
• Subjects who have scored at least 18 out of 27 for the Stress Incontinence Questions and are confirmed as having predominant stress urinary incontinence on the Medical, Epidemiologic and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire completed at the screening assessment.
• Subjects with a Body Mass Index of \< 30 kg/m2
• Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained.
• Subjects who are able to understand this study and are willing to complete all the study assessments.

You may not qualify if:

• Subjects who have an existing medical condition that would compromise their participation in the study.
• Subjects who have a physical condition that would make them unable to perform the study procedures.
• Subjects who have or a history of any respiratory condition including a chronic cough.
• Subjects with a history of an underlying neurological condition.
• Subjects with a history of low back pain involving the spinal nerve root.
• Subject who are currently taking medication, or have taken medication in the last 4 weeks, for urinary incontinence or that effect urinary output function including anti-cholinergics or anti-histamines or any anti-anxiety medications.
• Subjects with a blood clotting disorder or who are taking anti-coagulant medications.
• Subjects who have previously had any uro-gynaecological related surgery excluding hysterectomy.
• Subjects with a clinical diagnosis of prolapse greater than Stage 2.
• Subjects who are pregnant or could be pregnant.
• Subjects who are less than 6 months post-partum or who are lactating.
• Subjects who have any intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine.
• Subjects with pelvic pain or fibromyalgia or paravaginal defect.
• Subjects with an active implanted medical device (ie pacemaker, pump etc).
• Subjects with a history of heart disease or stroke.

Sponsors & Collaborators

• Bio-Medical Research, Ltd.: lead

Study Sites (1)

St. Hedwig Krankenhaus

Berlin, State of Berlin, 10115, Germany

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 Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 16, 2011
• Study Start: December 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

DE (1)