Clinical trial NCT04584359: Effects of Osteopathic Manipulations and Muscle Training on the Myoelectric Activity of the Pelvic Floor
Official title: Comparasion of the Effects of Osteopathic Manipulations and Muscle Training on the Myoelectric Activity of the Pelvic Floor in Women With Stress Urinary Incontinence: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: pelvic floor training
osteopathy
urinary incontinence
Lead sponsor: University of Trás-os-Montes and Alto Douro
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This study randomized 40 women with symptoms of stress uriray incontinence who were divided into four intervention groups of ten women each (G1: only the high velocity, low amplitude manipulation for the sacroiliac joint and T10-L2; G2: global osteopathic protocol with myofascial, visceral, and articular techniques; G3: pelvic floor muscle training; and G4: control).
Primary purpose: TREATMENT

Brief summary: The objective of this study was to compare the effects of four different interventions on pelvic floor muscle electromyographic activity in women with stress urinary incontinece: i) a global osteopathic protocol (myofascial, visceral, and articular techniques), ii) one manipulation technique (high velocity, low amplitude (HVLA)/thrust) of the sacroiliac joint and T10-L2, iii) Pelvic Floor Muscle training, and iv) a control group with no intervention. The hypothesis is that the global osteopathic protocol and HVLA technique can increase pelvic floor muscle electromyographic activity to a level greater than or equal to the standard care established in the literature (pelvic floor muscle training).

Detailed description: Participants represented a convenience sample and were recruited from hospitals, urogynecology doctors' clinics, invitations via social networks, gyms, clubs, and sports consultants. Women had to be between 30 and 60 years old and report symptoms of urine loss due to exertion in the last six months.The participants were randomly allocated into four groups (G1 = intervention using an HVLA/thrust technique for the sacroiliac and T10-L2 joints, G2 = global osteopathic protocol, G3 = PFT, and G4 = control) by a blinded researcher with a spreadsheet of random numbers.The primary outcome measure was surface electromyography (EMG) performed at five different times: before the intervention and immediately, 30 minutes, 60 minutes, and four weeks after. This evaluation was performed by a physiotherapist with ten years of experience in urogynecology and expertise in PFM electromyographic evaluation who was blinded to the group allocation.

Eligibility criteria: Inclusion Criteria:

* symptoms of urine loss due to exertion in the last six months.

Exclusion Criteria:

* urgent or mixed urinary incontinency
* overactive bladder
* neurological disorder
* urinary or anal infection
* urogenital atrophy
* pelvic organ prolapse grade 3 or 4
* sensory pathways and motor not intact
* spine fracture

Primary outcomes:
measure: electromyographic activity
timeFrame: Change from baseline versus immediately post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Giselle Notini Arcanjo
state: CE
Study officials:
affiliation: Tras dos Montes Alto Douro University
name: Giselle N Arcanjo
role: PRINCIPAL_INVESTIGATOR
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