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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2024-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stress Incontinence, Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)

Intervention Type DEVICE

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

Shock Wave group

30 patients will receive Low Intensity Extracorporeal Shock Wave Therapy and conventional pelvic floor muscle exercises.

Group Type EXPERIMENTAL

The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)

Intervention Type DEVICE

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

Pilates group

30 patients will receive Pilates exercises and conventional pelvic floor muscle exercises

Group Type EXPERIMENTAL

The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)

Intervention Type DEVICE

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

control group

30 patients will receive conventional pelvic floor muscle exercises

Group Type EXPERIMENTAL

The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Pilates exercises conventional pelvic floor muscle exercises

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No