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

Primary Purpose

Stress Urinary Incontinence

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electric DN
NM Re-ed
Exercise
Sponsored by
Alabama Physical Therapy & Acupuncture
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Research Physical Therapy Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electric DN, NM Re-ed, Exercise

NM Re-ed and Exercise

Arm Description

Outcomes

Primary Outcome Measures

Incontinence Impact Questionnaire - Short Form IIQ-7
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.

Secondary Outcome Measures

Global Rating of Change Scale
15 point self-report scale (-7 to 7). High rating indicates a greater impact of change
Urinary pad per day usage
Number of urinary pads that the patient requires per day secondary to stress urinary incontinence
Urogenital Distress Inventory
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.

Full Information

First Posted
August 1, 2017
Last Updated
August 19, 2019
Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT03238716
Brief Title
Neuromuscular Re-eduaction, Exercise and Electric Dry Needling vs. Neuromuscular Re-education and Exercise for Stress Urinary Incontinence
Official Title
Neuromuscular Re-education, Impairment-based Exercise and Electric Dry Needling vs. Neuromuscular Re-education and Impairment-based Exercise for Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit an adequate number of patients with stress urinary incontinence (based on inclusion / exclusion criteria) to participate in the study
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electric DN, NM Re-ed, Exercise
Arm Type
Experimental
Arm Title
NM Re-ed and Exercise
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Electric DN
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
NM Re-ed
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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).
Primary Outcome Measure Information:
Title
Incontinence Impact Questionnaire - Short Form IIQ-7
Description
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.
Time Frame
baseline, 6 weeks, 3 months
Secondary Outcome Measure Information:
Title
Global Rating of Change Scale
Description
15 point self-report scale (-7 to 7). High rating indicates a greater impact of change
Time Frame
6 weeks, 3 months
Title
Urinary pad per day usage
Description
Number of urinary pads that the patient requires per day secondary to stress urinary incontinence
Time Frame
baseline, 6 weeks, 3 months
Title
Urogenital Distress Inventory
Description
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.
Time Frame
baseline, 6 weeks, 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 35 - 75 years Female 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: Urge urinary incontinence or mixed urinary incontinence Greater than second degree prolapse Previous surgical intervention related to female anatomy Urinary tract infection Unable to participate in movement such as walking, stair climbing, or resistance training Taking medication that impacts bladder function Serious cardiovascular, cerebral disease, psychiatric disorder, cognitively impaired, injury of cauda equine, and/or myelopathy Pregnancy Sacral nerve stimulator implanted Cardiac pacemaker, metal allergy, or severe needle phobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Dunning, DPT
Organizational Affiliation
American Academy of Manipulative Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Physical Therapy Specialists
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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