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

• ClinicalTrials.gov Identifier: NCT03325660
• Recruitment Status: Completed
• First Posted: October 30, 2017
• Last Update Posted: July 5, 2019
• Sponsor: Ahlia University
• Collaborator: Cairo University
• Information provided by (Responsible Party): Dr Sayed Tantawy, Ahlia University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Sponsors and Collaborators

Ahlia University

Cairo University

Investigators

• Study Director: Sayed A A Tantawy, PhD; Cairo University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• 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:

Urinary Incontinence; Enuresis; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders