Whole Body Vibration and Pelvic Floor Exercises on Urinary Incontinence ([PTREC])
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|ClinicalTrials.gov Identifier: NCT03325660|
Recruitment Status : Completed
First Posted : October 30, 2017
Last Update Posted : July 5, 2019
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|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.|
|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|
Active Comparator: study group
whole body vibration
Other: whole body vibration
pelvic floor exercises
Other Name: pelvic floor exercises
No Intervention: control group
- 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
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
|Study Director:||Sayed A A Tantawy, PhD||Cairo University|