Pilates Training and Low Intensity Shock Wave Therapy for Post-prostatectomy Stress Incontinence

Not Applicable

• Conditions: Stress Incontinence, Male
• Interventions: Device: The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)

• Registration Number: NCT06322082
• Lead Sponsor: Khadra Mohamed Ali

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.

Study Timeline

• Study First Submitted: 2024-02-14
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-18
• Study Start: 2024-03-20
• Study First Posted: 2024-03-20
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pilates and Shock Wave group	The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)	30 patients will receive Pilates exercises combined with Low Intensity Extracorporeal Shock Wave Therapy and conventional pelvic floor muscle exercises
Pilates group	The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)	30 patients will receive Pilates exercises and conventional pelvic floor muscle exercises
Shock Wave group	The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)	30 patients will receive Low Intensity Extracorporeal Shock Wave Therapy and conventional pelvic floor muscle exercises.
control group	The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)	30 patients will receive conventional pelvic floor muscle exercises

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
body mass index	before treatment and after 3 months	measure ( weight per height squares )of patients kg/m\^2

Trial Locations

Locations (1)

faculty of physical therapy , Cairo university; 🇪🇬 Giza, Egypt