InterStim® Amplitude Study

Urinary Urge Incontinence Clinical Trial

Official title:

InterStim® Amplitude Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335761
• Other study ID #: MDT17030
• Status: Completed
• Phase: N/A
• Start date: February 27, 2018
• Est. completion date: November 6, 2019

Study information

• Verified date: December 2020
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).

Description:

This is a prospective, randomized, multicenter, single-blinded study to explore the efficacy and quality of life (QoL) of 3 different amplitude settings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: November 6, 2019
• Est. primary completion date: November 6, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline voiding diary demonstrating at least 3 UUI episodes

2. Female subjects 18 years of age or older

3. Candidate for InterStim Lead Placement

4. Willing and able to accurately complete voiding diaries, questionnaires, attend visits, and comply with the study protocol (which includes maintenance of InterStim II programming settings over the course of the study)

5. Willing and able to provide signed and dated informed consent

6. Willing to maintain current regimen (dosage and frequency) of any overactive bladder (OAB) medication

Exclusion Criteria:

1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury

2. History of diabetes unless the diabetes is well-controlled through diet and/or medications

3. Symptomatic urinary tract infection (UTI)

4. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component

5. Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study

6. Implanted with a neurostimulator, pacemaker, or defibrillator

7. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the MRI Guidelines for InterStim Therapy

8. Women who are pregnant or planning to become pregnant

9. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.

10. Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study (co-enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager (or designee).

Related Conditions & MeSH terms

• Urinary Incontinence, Urge
• Urinary Urge Incontinence

Intervention

Device:
• InterStim Therapy
Device Programming

Locations

Country	Name	City	State
Belgium	UZ Leuven - Campus Gasthuisberg - Department Urology	Leuven
Canada	University Urology Associates, Toronto Western Hospital	Toronto	Ontario
France	CHU Hôpitaux de Rouen - Hôpital Charles Nicolle	Rouen
Italy	Azienda Ospedaliera Universitaria Integrata Verona	Verona
Netherlands	Erasmus MC	Rotterdam
United Kingdom	University College London Hospitals NHS Foundation Trust - University College Hospital	London
United States	Chattanooga Hamilton County Hospital Authority d/b/a Erlanger Health System	Chattanooga	Tennessee
United States	Carolina Urology Partners	Concord	North Carolina
United States	Urologic Research & Consulting	Englewood	New Jersey
United States	Minnesota Urology Fridley	Fridley	Minnesota
United States	East Coast Institute for Research	Jacksonville	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Adult Pediatric Urology and Urogynecology	Omaha	Nebraska
United States	Academic Urology & Urogynecology of Arizona	Phoenix	Arizona
United States	Pinellas Urology	Saint Petersburg	Florida
United States	Florida Urology Partners	Tampa	Florida
United States	Aurora Research Institute - Aurora West Allis Women's Pavilion	West Allis	Wisconsin
United States	Minnesota Urology Woodbury	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks.	Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.	12 weeks
Secondary	Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks.	International Consultation on Incontinence Modular Questionnaire - Overactive Bladder Symptoms Quality of Life Questionnaire The questionnaire consists of 4 subscales and a single item on urinary symptom interference.; The four subscales of Concern (7 items), Coping (8 items), Sleep (5 items), and Social (5 items) are measured on a scale from 0-100 using a range percentile transformation on the summed value from individual listed items. The Health-Related Quality of Life (HRQL) score is a calculated score with a range from 0 to 100 using a range percentile transformation on the summed value from the subscales. Subjects were asked a urinary symptom interference question. "Interference" was measured on a scale from 0-10.; A positive change in Concern, Coping, Sleep, Social, and HRQL indicates improvement in Quality of Life; a negative change in Interference indicates improvement in Quality of Life.	12 weeks