NCT03975686

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

May 31, 2019

Last Update Submit

March 30, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • bladder base elevation

    the ability to contract pelvic floor muscle measured as bladder base elevation by transabdominal ultrasound

    one week

Study Arms (2)

intervention

EXPERIMENTAL
Other: neuromuscual realigning exercise

control

NO INTERVENTION

Interventions

neuromuscular realigning exercise

intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Positive Ober's test

You may not qualify if:

  • pelvic/low back pain in previous 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Georgia

Dahlonega, Georgia, 30533, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mahshid A Chehrehrazi, Student

    University of North Georgia

    STUDY DIRECTOR
  • Mohammad R Nourbakhsh, professor

    University of North Georgia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad R Nourbakhsh, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

May 31, 2019

First Posted

June 5, 2019

Study Start

June 1, 2020

Primary Completion

July 30, 2020

Study Completion

August 29, 2020

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations