Stress Incontinence, Male
Conditions
Brief summary
120 Patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy, group B receive Low Intensity Extracorporeal Shock Wave Therapy, group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises. Assessment at baseline, immediately after the intervention, to evaluate the degree of urinary incontinence and quality of life after three months from treatment.
Detailed description
120 Patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy, group B receive Low Intensity Extracorporeal Shock Wave Therapy, group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises. Assessment at baseline, immediately after the intervention, to evaluate the degree of urinary incontinence by Urodynamic investigation system, Severity index scale and Cytometry and quality of life by The quality of life questionnaire IQOL after three months from treatment.
Interventions
DEVICEThe DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)
The LiESWT was applied to Pilates and Shock Wave group and Shock Wave group with 0.25 mJ/mm2 of intensity, 3000 pulses of shock, and 3 pulses/s of frequency, applicator was placed on the suprapubic skin area one session in the week for twelve weeks, totaling 12 sessions. Pilates exercises were performed to Pilates and Shock Wave group and Pilates group. The sessions of Pilates were applied twice a week for twelve weeks, totaling 24 sessions. The 50 min Pilates sessions were divided into three phases: warm-up, strengthening, and stretching. They also received written orientations to perform three exercises and two of the Pilates session at home every day - Conventional pelvic floor exercises performed for all groups include Kegel exercise, squats, bridging, and squeeze and release exercises. These exercises were performed 3 times per day, lasting for 12 consecutive weeks
Sponsors
Cairo University
Khadra Mohamed Ali
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* All patients diagnosed as urinary incontinence. * Age between 40 -75 male patients or older. * All patients received the same medical treatment
Exclusion criteria
* adjuvant or neoadjuvant chemo-radiation therapy. * severe postoperative complications. * history of pelvic surgery, and diseases that could affect voiding function and limitations for the exercise program such as for patients with serious cardiovascular events or spinal or articular disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cystometry | before treatment and after 3 months | Ithe dynamic measurement of detrusor pressure during the continuous filling of the bladder. |
| Severity index scale | before treatment and after 3 months | measure frequency and amount of urine loss ,calculated by this equation: Severity index of incontinence = (Points for frequency of urine loss) × (Points for amount of urine loss) calculated by this equation: Severity index of incontinence = (Points for frequency of urine loss) × (Points for amount of urine loss) measure frequency and amount of urine loss to calculate severity of incontinence, o Frequency of urine loss grades: Never = 0 less than once a month= 1 once to several times a month = 2 once to several times a week = 3 Every day and/or night = 4 * o Amount of urine loss grades: No drop (completely dry) = 0 A few drops = 1 A little = 2 More = 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body mass index | before treatment and after 3 months | measure ( weight per height squares )of patients kg/m\^2 |
Countries
Egypt
Outcome results
None listed