Effects of Neuromuscular Pelvic Realigning Exercises on Pelvic Floor Muscle Function in Continent SubjectS

Effects of Neuromuscular Pelvic Realigning Exercises on Pelvic Floor Muscle Function in Continent Subjects: A Randomized Control Trial

The goal of this research study is to investigate the effect of a new neuromuscular approach for correcting pelvic alignment and improving pelvic floor muscle function. Investigators hypothesized that this approach would be significantly superior than no intervention to improve the ability of pelvic floor muscle contraction, measured by transabdominal sonography as bladder base elevation. Participants will be randomized to the intervention and control groups. while intervention group will receive five supervised sessions of pelvic realigning exercises, the control group will receive no intervention. Bladder base elevation will be measured as an indicator of pelvic floor muscle function, before and after one week intervention in both control and intervention groups.

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence; Pelvic Floor Muscle Weakness; Pelvic Asymmetry
• Intervention / Treatment: Other: neuromuscual realigning exercise

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Dahlonega, Georgia, United States, 30533
      • Recruiting
      • University of North Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Positive Ober's test

Exclusion Criteria:

• pelvic/low back pain in previous 12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control
EXPERIMENTAL: intervention	Other: neuromuscual realigning exercise; neuromuscular realigning exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bladder base elevation	the ability to contract pelvic floor muscle measured as bladder base elevation by transabdominal ultrasound	one week

Collaborators and Investigators

• Sponsor: University of North Georgia
• Investigators: Study Director: Mahshid A Chehrehrazi, Student, University of North Georgia; Principal Investigator: Mohammad R Nourbakhsh, professor, University of North Georgia

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): July 30, 2020
• Study Completion (ANTICIPATED): August 29, 2020

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (ACTUAL): June 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Urination Disorders; Neuromuscular Manifestations; Urinary Incontinence; Muscle Weakness; Urinary Incontinence, Stress
• Other Study ID Numbers: UNorthGeorgia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No