Neuromuscular Re-eduaction, Exercise and Electric Dry Needling vs. Neuromuscular Re-education and Exercise for Stress Urinary Incontinence

August 19, 2019 updated by: James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture

Neuromuscular Re-education, Impairment-based Exercise and Electric Dry Needling vs. Neuromuscular Re-education and Impairment-based Exercise for Stress Urinary Incontinence

The purpose of this research is to compare two different approaches for treating patients with stress urinary incontinence: neuromuscular re-education, impairment-based exercise and electric dry needling versus neuromuscular re-education and impairment-based exercise. Physical therapists commonly use all of these techniques to treat stress urinary incontinence. This study is attempting to find out if one treatment strategy is more effective than the other.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with stress urinary incontinence will be randomized to receive 2 treatment sessions per week for up to 6 weeks (8-12 sessions total) of either: (1) neuromuscular re-education, impairment-based exercise and electric dry needling (2) neuromuscular re-education and impairment-based exercise

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Research Physical Therapy Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Aged 35 - 75 years
  2. Female
  3. Meet the diagnosis of stress urinary incontinence - urine leakage with increased abdominal pressure from laughing, sneezing, coughing, or other physical stressors on abdominal cavity and bladder

Exclusion Criteria:

  1. Urge urinary incontinence or mixed urinary incontinence
  2. Greater than second degree prolapse
  3. Previous surgical intervention related to female anatomy
  4. Urinary tract infection
  5. Unable to participate in movement such as walking, stair climbing, or resistance training
  6. Taking medication that impacts bladder function
  7. Serious cardiovascular, cerebral disease, psychiatric disorder, cognitively impaired, injury of cauda equine, and/or myelopathy
  8. Pregnancy
  9. Sacral nerve stimulator implanted
  10. Cardiac pacemaker, metal allergy, or severe needle phobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Electric DN, NM Re-ed, Exercise
Other: Electric DN
Dry needling with electric stimulation to the erector spine and paraspinal muscles in the lumbar / sacral region and tibialis anterior / posterior. Dry needling with electric stimulation of peri-neural tissue associated with lumbar / sacral nerve roots, pudendal nerve and posterior tibial nerve. 8-12 treatment sessions over 6 weeks.
Other: NM Re-ed
sEMG targeting type I slow-twitch fibers and type II fast-twitch fibers. Type I fibers maintain continuous muscle activity over prolonged periods of time; therefore, training of type I fibers will be achieved through endurance and repetition training of the pelvic floor muscles. Type II fibers are recruited during sudden increases in intra-abdominal pressure, and these fibers will be recruited with "The Knack" training. The Knack is a term created to use rhythm or timing to the pelvic floor. Neuromuscular re-education will be performed during the first treatment, but it will be performed "as needed" on subsequent treatments.
Other: Exercise
Impairment-specific strength training, which may include transversus abdominis (TrA), gluteus maximus/medius/minimus and/or hip abductor/adductor muscle training. Treadmill, riding the recumbent bike at > 2 METs and/or stair climbing. Exercise training will be performed 7-11 treatment sessions over 6 weeks (following treatment 1).
Active Comparator: NM Re-ed and Exercise
Other: NM Re-ed
sEMG targeting type I slow-twitch fibers and type II fast-twitch fibers. Type I fibers maintain continuous muscle activity over prolonged periods of time; therefore, training of type I fibers will be achieved through endurance and repetition training of the pelvic floor muscles. Type II fibers are recruited during sudden increases in intra-abdominal pressure, and these fibers will be recruited with "The Knack" training. The Knack is a term created to use rhythm or timing to the pelvic floor. Neuromuscular re-education will be performed during the first treatment, but it will be performed "as needed" on subsequent treatments.
Other: Exercise
Impairment-specific strength training, which may include transversus abdominis (TrA), gluteus maximus/medius/minimus and/or hip abductor/adductor muscle training. Treadmill, riding the recumbent bike at > 2 METs and/or stair climbing. Exercise training will be performed 7-11 treatment sessions over 6 weeks (following treatment 1).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incontinence Impact Questionnaire - Short Form IIQ-7
Time Frame: baseline, 6 weeks, 3 months
7 questions, each worth 0-3 points. The average score of items responded to is calculated, then multiplied by 33 1/3 to put the scores on a scale of 0 to 100. High scores indicate greater impact of incontinence.
baseline, 6 weeks, 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Global Rating of Change Scale
Time Frame: 6 weeks, 3 months
15 point self-report scale (-7 to 7). High rating indicates a greater impact of change
6 weeks, 3 months
Urinary pad per day usage
Time Frame: baseline, 6 weeks, 3 months
Number of urinary pads that the patient requires per day secondary to stress urinary incontinence
baseline, 6 weeks, 3 months
Urogenital Distress Inventory
Time Frame: baseline, 6 weeks, 3 months
6 questions, each worth 0-3 points. The raw score is divided by 6 then multiplied by 25 for the total score. High scores indicate more distress due to bladder symptoms.
baseline, 6 weeks, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alabama Physical Therapy & Acupuncture

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad Rey Juan Carlos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAMT0015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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