Virtual Reality in the Treatment of Pelvic Floor Dysfunction in Women With Multiple Sclerosis

Universidad de Almeria

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Treatments: Other: Neuromodulation of the tibialis posterior nerve; Other: Virtual reality; Other: Pelvic floor muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT06576947

UALBIO2024/015

Details and patient eligibility

About

The purpose of the current randomized clinical trial was to compare the effectiveness of virtual reality versus posterior tibial nerve stimulation on the improvement of pelvic floor dysfunctions in women with multiple sclerosis.

Full description

• Design: Randomized Clinical Trial. Objective: to determine the effects of virtual reality versus posterior tibial nerve stimulation and muscle activation exercises on the improvement of pelvic floor dysfunctions in women with multiple sclerosis.
• Methods and Measures: forty five women will be randomly assigned to one of three groups.
• Intervention: For 8-week, the group 1 will undergo treatment with virtual reality (2/week), the group 2 will receive posterior tibial nerve stimulation (2/week) and the group 3 will receive muscle activation exercises of the pelvic floor.
• Main Outcome Measures: assessment of pelvic floor muscles function (strength and muscle tone), urodynamic studies, and validated questionnaires data will be collected at baseline, and 1 week after the last therapy application. Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure.

Enrollment: 45 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of multiple sclerosis
• Presence of pelvic floor dysfunction
• Acceptance participation
• Not undergoing another physical therapy treatment

Exclusion criteria

• Non-acceptance of participation
• Mental illness
• Interruption of adherence to protocolized treatment sessions
• Indication of surgical treatment in the pelvic floor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Virtual reality therapy

Experimental group

Description:

It will ve placement of virtual reality glasses that will indicate to the patient when to contract the pelvic floor.

Treatment:

Other: Virtual reality

Neuromodulation of the tibialis posterior

Experimental group

Description:

Is placed a external electrode 5 centimeters (cm) above the medial malleolus and 1 cm behind of the tibia and another electrode on the medial aspect of the foot, below the malleolus. The kind of electric current used will be rectangular, biphasic, with a pulse duration of 220 Ps and a frequency of 10 Hz. To avoid habituation to the current, a phase of 20 s stimulation with a 4 s rest phase. The intensity of the current will be inframotor, just below the contraction threshold of the flexor digitorum muscle brevis.

Treatment:

Other: Neuromodulation of the tibialis posterior nerve

Pelvic Floor Muscle Training

Experimental group

Description:

Patients will perform Pelvic Floor Muscle Training. Before performing this treatment at home, a session will be held with an expert physiotherapist in pelvic floor who will explain its implementation to the participants of this group.

Treatment:

Other: Pelvic floor muscle training