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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Other: Electric DN
* Other: NM Re-ed
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electric DN, NM Re-ed, Exercise<br> | Other: Electric DN<br>* 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.<br>Other: NM Re-ed<br>* 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.<br>Other: Exercise<br>* 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).<br>|
| Active Comparator: NM Re-ed and Exercise<br> | Other: NM Re-ed<br>* 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.<br>Other: Exercise<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 6 weeks, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Rating of Change Scale | 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 | Number of urinary pads that the patient requires per day secondary to stress urinary incontinence | baseline, 6 weeks, 3 months | 
| 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. | baseline, 6 weeks, 3 months |