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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedStudy Start
First participant enrolled
March 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2024
CompletedMarch 28, 2024
March 1, 2024
7 months
February 14, 2024
March 27, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
body mass index
before treatment and after 3 months
Study Arms (4)
Pilates and Shock Wave group
EXPERIMENTAL30 patients will receive Pilates exercises combined with Low Intensity Extracorporeal Shock Wave Therapy and conventional pelvic floor muscle exercises
Shock Wave group
EXPERIMENTAL30 patients will receive Low Intensity Extracorporeal Shock Wave Therapy and conventional pelvic floor muscle exercises.
Pilates group
EXPERIMENTAL30 patients will receive Pilates exercises and conventional pelvic floor muscle exercises
control group
EXPERIMENTAL30 patients will receive conventional pelvic floor muscle exercises
Interventions
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
Eligibility Criteria
You may qualify if:
- All patients diagnosed as urinary incontinence.
- Age between 40 -75 male patients or older.
- All patients received the same medical treatment
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Khadra Mohamed Alilead
- Cairo Universitycollaborator
Study Sites (1)
faculty of physical therapy , Cairo university
Giza, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marwa Eid
Professor at Faculty of physical therapy, Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- assist professor
Study Record Dates
First Submitted
February 14, 2024
First Posted
March 20, 2024
Study Start
March 20, 2024
Primary Completion
October 30, 2024
Study Completion
December 15, 2024
Last Updated
March 28, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- 3 months
- 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.
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.