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Whole Body Vibration and Pelvic Floor Exercises on Urinary Incontinence ([PTREC])

A

Ahlia University

Status

Completed

Conditions

Urinary Incontinence

Treatments

Other: whole body vibration

Study type

Interventional

Funder types

Other

Identifiers

NCT03325660
P.T. REC/012/001250

Details and patient eligibility

About

Stress urinary incontinence is common in men following prostate cancer surgery. Rehabilitative interventions incorporate pelvic floor muscle training, biofeedback, electrical stimulation, lifestyle changes, or a combination of these strategies. However, little is known about the physiological impact of whole-body vibration for stress urinary incontinence following radical prostatectomy. Participants: Sixty-one patients with mild Stress urinary incontinence after radical prostatectomy.

Intervention: patients were randomly assigned into two groups: group 1 included 30 patients who received pelvic floor muscle training and whole-body vibration training with a frequency and amplitude of 20 Hz/ 2 mm for the first 2 sessions and 40 Hz/ 4 mm for the rest of intervention; while group 2 included 31 patients who performed only pelvic floor muscle training. The intervention in both groups was performed three times per week for 4 weeks.

Full description

Participants were recruited from Cairo University Hospitals who suffered from mild SUI for at least 6 months after RP. The diagnosis was confirmed by the referred physician via 24-h pad test which supposed to be less than 100 grams gain of weight of the pad/s worn by the patient.

The exclusion criteria were artificial pacemaker, body mass index (BMI)> 35 kg/m2, urinary infection, bleeding from the urinary bladder or the digestive tract, polyuria, diabetes mellitus, detrusor over-activity, neuromuscular disorder, ear problems or any other medical condition that would affect participation in the training program. Main outcomes: Incontinence Visual Analogue Scale (I-VAS), the International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) and 24-hour pad test.

Enrollment

61 patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The initial sample was adult patients suffering from urinary incontinence at least 6 months after radical prostatectomy.

Exclusion criteria

  • The exclusion criteria included patients with an artificial pacemaker, body mass index more than 35 kg/ m2, urinary infection, bleeding from the urinary bladder or the digestive tract, polyuria, diabetes mellitus, detrusor instability, neuromuscular disorders, and any other medical condition that affects participation in the training program.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

61 participants in 2 patient groups

study group
Active Comparator group
Description:
whole body vibration
Treatment:
Other: whole body vibration
control group
No Intervention group
Description:
No intervention

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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