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

K

Khadra Mohamed Ali

Status

Invitation-only

Conditions

Stress Incontinence, Male

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06322082
1422024

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

Male

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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