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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03238716
• Other study ID #: AAMT0015
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: August 2019
• Source: Alabama Physical Therapy & Acupuncture
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.
• 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.
• 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).

Locations

Country	Name	City	State
United States	Research Physical Therapy Specialists	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alabama Physical Therapy & Acupuncture	Universidad Rey Juan Carlos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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