Stress Urinary Incontinence
Conditions
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
Interventions
OTHERElectric 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.
OTHERNM 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.
OTHERExercise
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).
Sponsors
Universidad Rey Juan Carlos
Alabama Physical Therapy & Acupuncture
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incontinence Impact Questionnaire - Short Form IIQ-7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Rating of Change Scale | 6 weeks, 3 months | 15 point self-report scale (-7 to 7). High rating indicates a greater impact of change |
| Urinary pad per day usage | baseline, 6 weeks, 3 months | Number of urinary pads that the patient requires per day secondary to stress urinary incontinence |
| Urogenital Distress Inventory | 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. |
Countries
United States
Outcome results
None listed