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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03325660
Recruitment Status : Completed
First Posted : October 30, 2017
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Dr Sayed Tantawy, Ahlia University

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.


Condition or disease Intervention/treatment Phase
Urinary Incontinence Other: whole body vibration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The study group included 30 patients participated in pelvic floor muscle training and whole-body vibrations, 3 times weekly for 4 consecutive weeks; the frequency and peak-to-peak displacement of vibration were 2 mm/20 Hz for the first week for 5 minutes, 3mm/25 Hz, 10 minutes for the second week and 4 mm/30 Hz, 15 minutes for the last two weeks. The control group included 31 patients received only pelvic floor training only. Pelvic floor exercises: Each patient was prepared and taught a program of pelvic floor exercises to be performed in daily sessions in lying, sitting, and standing positions consisting of 10 seconds of contractions followed by 10 seconds of relaxation and repeating the exercises 15 times each session.
Primary Purpose: Treatment
Official Title: The Role of Whole Body Vibration and Pelvic Floor Muscle Exercises in Treating Urinary Incontinence Following Prostate Cancer Surgery: A Comparative Randomized Controlled Trial
Actual Study Start Date : July 3, 2016
Actual Primary Completion Date : March 5, 2017
Actual Study Completion Date : October 27, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: study group
whole body vibration
Other: whole body vibration
pelvic floor exercises
Other Name: pelvic floor exercises

No Intervention: control group
No intervention



Primary Outcome Measures :
  1. Incontinence Visual Analogue Scale (I-VAS) [ Time Frame: 7 months ]
    For the I-VAS, patients were asked to depict their subjective burden of incontinence on a 100-mm VAS. The question above the VAS line was: 'How annoyed are you by incontinence currently?' The 100-mmVAS scale scores ranged from 0 ('not irritated') to 10 ('extremely disturbed'). A 100-mm line labelled from 0 to 10 was used, with patients asked to mark their answer on the line. The I-VAS is a valid, reproducible and responsive tool for UI treatment and improving the quality of life of patients after urogynaecologic surgery



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male patients suffering from urinary incontinence after prostate cancer surgery
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325660


Sponsors and Collaborators
Ahlia University
Cairo University
Investigators
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Study Director: Sayed A A Tantawy, PhD Cairo University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Sayed Tantawy, Associate Professor, Ahlia University
ClinicalTrials.gov Identifier: NCT03325660    
Other Study ID Numbers: P.T. REC/012/001250
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr Sayed Tantawy, Ahlia University:
Whole body vibration, Pelvic floor muscle
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders