Cycling Versus Continuous Mode in Neuromodulator Programming

NCT02551822 | Completed Results

• 1 other identifier: 12-133
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators objective is to compare patient outcomes as changes in validated symptom measures of overactive bladder, the Overactive Bladder Questionnaire Short Form (OABq-SF) symptom scale, between women who are set on cycling versus continuous programs for their neuromodulator. Specifically, the investigators propose to perform a randomized double blind crossover study in women who are successfully treated with neuromodulation to either continuous or cycling mode on the modulator and compare differences between groups on the validated OABq-SF symptom questionnaire. In addition, the investigators will compare differences in urinary frequency and pad counts between women randomized to cycling versus continuous stimulation as measured by a 3 day voiding diary. This investigation will provide evidence-based guidelines for neuromodulator programming.

Conditions

Urinary Incontinence, Urge

Keywords

Urge Urinary Incontinence, sacral neuromodulation

Outcome Measures

Primary Outcomes (1)

• Overactive Bladder Questionnaire-Short Form (OABq) Short Form Symptom Bother Scale Result

  The Overactive Bladder Questionnaire (OAB-q) assesses symptom bother \& health-related quality of life (HRQL) for overactive bladder. The short form OAB-q SF, provides a quick assessment of symptom bother, consisting of a 6-item symptom bother scale. The questionnaire is on a 6 point scale, 1 indicates symptom is not bothersome (best outcome), 6 indicates symptom bothers the participant "a very great deal" (worst possible outcome). The majority of the participants were missing the HRQL portion of the questionnaire, so this portion of the questionnaire was not included in the analysis. These are the raw scores ranges for each question prior to being transformed. The possible scores for complete surveys range from 13 (if the participant marked "not bothersome" for all 6) to 78 (if the participant marked "a very great deal" for all 6 questions) once transformed. The reported numbers are the transformed scores \[(actual raw score-lowest possible score)/possible raw score range\] X 100.

  Three months after change in program from cycling to continuous or vice versa.

Secondary Outcomes (2)

• Voiding Diary: Urge Incontinence Episodes

  Three months after change in program from cycling to continuous or vice versa.

• Patient Global Impression of Improvement (PGI-I) Questionnaire Scale Results

  Three months after change in program from cycling to continuous or vice versa.

Study Arms (2)

Cycling

ACTIVE COMPARATOR

Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a "cycling" program.

Device: sacral neuromodulator

Continuous

ACTIVE COMPARATOR

Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a "continuous" program.

Device: sacral neuromodulator

Interventions

sacral neuromodulator DEVICE

The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.

Also known as: Interstim

Continuous; Cycling

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women at least 21 years old or older eligible for implantation of a neuromodulator
• Women with successful Stage #1 implantation for treatment of refractory OAB
• Subjects may be enrolled in other studies as long as there are no changes to the neuromodulation device. Women may continue other OAB therapies that they are on, but as asked to not start new therapies.
• Not currently pregnant and with no plans to become pregnant during the course of the trial.
• Willing as well as mentally and physically capable of completing all study related procedures and materials

You may not qualify if:

• Males (we do not care for males in our urogynecology clinic)
• Incarcerated women
• Non-English speakers
• Pregnant women
• Scheduled or planned MRIs or diathermy

Sponsors & Collaborators

• University of New Mexico: lead
• Society of Urologic Nurses and Associates: collaborator

Study Sites (2)

University of New Mexico Hospital

Albuquerque, New Mexico, 87108, United States

Location

University of New Mexico Health Science Center

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

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

Results Point of Contact

• Title: Dr. Yuko Komesu, MD
• Organization: University of New Mexico Health Sciences Center, Department of Obstetrics & Gynecology, Division of Urogynecology

YKomesu@salud.unm.edu

505-272-6382

Study Officials

• Yuko M Komesu, MD

  University of New Mexico Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Gwendolyn Beer, RN

  University of New Mexico Health Sciences Center

  STUDY CHAIR

• Rebecca G Rogers, MD

  University of New Mexico Health Sciences Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 16, 2015
• Study Start: July 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 27, 2018
• Results First Posted: April 27, 2018

Record last verified: 2018-04

Locations

US (2)