Whole Body Vibration and Pelvic Floor Exercises on Urinary Incontinence

NCT ID: NCT03325660

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-03
• Study Completion Date: 2017-10-27

Brief Summary

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.

Detailed 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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

study group

whole body vibration

Group Type: ACTIVE_COMPARATOR

whole body vibration

Intervention Type: OTHER

pelvic floor exercises

control group

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

whole body vibration

pelvic floor exercises

Intervention Type: OTHER

Other Intervention Names

pelvic floor exercises

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Ahlia University

OTHER

Sponsor Role: lead

Responsible Party

Dr Sayed Tantawy

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sayed A A Tantawy, PhD

Role: STUDY_DIRECTOR

Cairo University

References

Tantawy SA, Elgohary HMI, Abdelbasset WK, Kamel DM. Effect of 4 weeks of whole-body vibration training in treating stress urinary incontinence after prostate cancer surgery: a randomised controlled trial. Physiotherapy. 2019 Sep;105(3):338-345. doi: 10.1016/j.physio.2018.07.013. Epub 2018 Sep 25.

Reference Type: DERIVED

PMID: 30630622 (View on PubMed)

Other Identifiers

P.T. REC/012/001250

Identifier Type: -

Identifier Source: org_study_id