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

NCT03238716 | Terminated

• 1 other identifier: AAMT0015
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Global Rating of Change Scale

  6 weeks, 3 months

• Urinary pad per day usage

  baseline, 6 weeks, 3 months

• Urogenital Distress Inventory

  baseline, 6 weeks, 3 months

Study Arms (2)

Electric DN, NM Re-ed, Exercise

EXPERIMENTAL

Other: Electric DN; Other: NM Re-ed; Other: Exercise

NM Re-ed and Exercise

ACTIVE COMPARATOR

Other: NM Re-ed; Other: Exercise

Interventions

Electric DN OTHER

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.

Electric DN, NM Re-ed, Exercise

NM Re-ed OTHER

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.

Electric DN, NM Re-ed, Exercise; NM Re-ed and Exercise

Exercise OTHER

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).

Electric DN, NM Re-ed, Exercise; NM Re-ed and Exercise

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alabama Physical Therapy & Acupuncture: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Research Physical Therapy Specialists

Columbia, South Carolina, 29203, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Exercise

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• James Dunning, DPT

  American Academy of Manipulative Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: July 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

US (1)