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

Pilates Training Combined With Low Intensity Shock Wave Therapy on Post-prostatectomy Stress Incontinence: Randomized Controlled Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stress Incontinence, Male
• Intervention / Treatment: Device: The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • faculty of physical therapy , Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilates and Shock Wave group; 30 patients will receive Pilates exercises combined with Low Intensity Extracorporeal Shock Wave Therapy and conventional pelvic floor muscle exercises	Device: The 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; Other Names: Pilates exercises; conventional pelvic floor muscle exercises
Experimental: Shock Wave group; 30 patients will receive Low Intensity Extracorporeal Shock Wave Therapy and conventional pelvic floor muscle exercises.	Device: The 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; Other Names: Pilates exercises; conventional pelvic floor muscle exercises
Experimental: Pilates group; 30 patients will receive Pilates exercises and conventional pelvic floor muscle exercises	Device: The 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; Other Names: Pilates exercises; conventional pelvic floor muscle exercises
Experimental: control group; 30 patients will receive conventional pelvic floor muscle exercises	Device: The 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; Other Names: Pilates exercises; conventional pelvic floor muscle exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cystometry	Ithe dynamic measurement of detrusor pressure during the continuous filling of the bladder.	before treatment and after 3 months
Severity index scale	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	before treatment and after 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body mass index	measure ( weight per height squares )of patients kg/m^2	before treatment and after 3 months

Collaborators and Investigators

• Sponsor: Khadra Mohamed Ali
• Collaborators: Cairo University
• Investigators: Principal Investigator: Marwa Eid, Professor at Faculty of physical therapy, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence, Stress
• Other Study ID Numbers: 1422024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 120 male Patients with urinary incontinence would be randomly assigned to 4 groups all receive conventional pelvic floor exercises(CPFE) plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy (LiECSWT), group B receive (LiECSWT), group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises only. (LiECSWT) was applied with 0.25 mJ/mm2 of intensity, 3000 pulses of shock, and 3 pulses/s of frequency, one session in the week for twelve weeks. Pilates exercises twice a week for twelve weeks, totaling 24 sessions and (CPFE) were performed 3 times per day, lasting for 12 consecutive weeks. Assessment at baseline, immediately after the intervention, by Urodynamic investigation system, Severity index scale, Cytometry and The quality of life questionnaire IQOL.
• IPD Sharing Time Frame: 3 months

IPD Sharing Access Criteria

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 serious cardiovascular events or spinal or articular disease.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No