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

Not Applicable

Terminated

• Conditions: Stress Urinary Incontinence
• Interventions: Other: Electric DN; Other: NM Re-ed; Other: Exercise

• Registration Number: NCT03238716
• Lead Sponsor: Alabama Physical Therapy & Acupuncture

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

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-03
• Primary Completion: 2019-03-01
• Study Completion: 2019-05-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electric DN, NM Re-ed, Exercise	NM Re-ed	-
Electric DN, NM Re-ed, Exercise	Electric DN	-
Electric DN, NM Re-ed, Exercise	Exercise	-
NM Re-ed and Exercise	Exercise	-
NM Re-ed and Exercise	NM Re-ed	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Research Physical Therapy Specialists; 🇺🇸 Columbia, South Carolina, United States