Extracorporeal Shock Wave Therapy to Kegel's Exercise in Management of Female Stress Urinary

NCT07663968 | Not Yet Recruiting DMC

• 1 other identifier: extracorporeal shock
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

Stress urinary incontinence (SUI) is a common pelvic floor disorder among women, especially those with a history of childbirth, aging, or pelvic surgery. Stress urinary incontinence is defined as the complaint of involuntary leakage on effort or exertion, or on sneezing or coughing. The condition significantly affects quality of life, emotional well-being, and daily functioning.

Conditions

Female Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Change in frequency and severity of stress urinary incontinence episodes

  Change in frequency and severity of stress urinary incontinence episodes, evaluated by the validated International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) The ICIQ-SF consists of three main questions that contribute to the overall score. Each question is scored as follows: 1. Frequency of leakage: 0 (Never) to 5 (All the time) 2. Volume of leakage: 0 (None) to 6 (A large amount) 3. Impact on daily life: 0 (Not at all) to 10 (A very great deal) Total Score Range: Minimum Value: 0 (indicating no urinary incontinence, no leakage, and no impact on quality of life) Maximum Value: 21 (indicating severe urinary incontinence, with frequent leakage and a significant impact on daily life) The total score allows healthcare providers to evaluate the severity of a patient's urinary incontinence and track changes over time.

  Patients will be assessed at 4 weeks, 8 weeks, 12 weeks, and 3 months from the date of the intervention startup.

Secondary Outcomes (1)

• Change in quality of life

  Patients will be assessed at 4 weeks, 8 weeks, 12 weeks, and 3 months from the date of the intervention startup.

Study Arms (2)

Low-intensity extracorporeal shock (LiESWT) + Kegel's exercise (KE)

ACTIVE COMPARATOR

Receives low-intensity extracorporeal shock (LiESWT) once weekly. Frequency: 3 Hz, 3000 shocks/session; Duration: 15-20 minutes/session placed on the perineal region, the left side, and the right side of the labia minora. In addition to daily Kegel's exercise (KE) for 8 weeks.

Radiation: low-intensity extracorporeal shock (LiESWT); Behavioral: Kegel's exercises (KE)

Kegel's exercise (KE) only

ACTIVE COMPARATOR

Daily Kegel's exercise (KE) Frequency: 3 sessions/day each A session is 10 repetitive pelvic floor muscle contractions. Each contraction will be held for 5 seconds, followed by 5 seconds of relaxation for 8 weeks.

Behavioral: Kegel's exercises (KE)

Interventions

low-intensity extracorporeal shock (LiESWT) RADIATION

receives low-intensity extracorporeal shock (LiESWT) once weekly. Frequency: 3 Hz, 3000 shocks/session; Duration: 15-20 minutes/session placed on the perineal region, the left side, and the right side of the labia minora.

Low-intensity extracorporeal shock (LiESWT) + Kegel's exercise (KE)

Kegel's exercises (KE) BEHAVIORAL

Daily Kegel's exercise (KE) Frequency: 3 sessions/day each A session is 10 repetitive pelvic floor muscle contractions. Each contraction will be held for 5 seconds, followed by 5 seconds of relaxation for 8 weeks.

Kegel's exercise (KE) only; Low-intensity extracorporeal shock (LiESWT) + Kegel's exercise (KE)

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Married Females
• Diagnosed with stress urinary incontinence, confirmed by clinical evaluation.
• Ability and willingness to perform KE and attend follow-up visits.
• Accepting informed consent.

You may not qualify if:

• Mixed urinary incontinence.
• Active urinary tract infection (symptomatic or laboratory) confirmed).
• Known coagulopathy or ongoing anticoagulant therapy.
• Neurological disorders (e.g., multiple sclerosis, stroke, spinal cord injury) or use of medications affecting bladder control.
• Pregnancy or recent childbirth (within 6 months)
• History of pelvic malignancy affecting urinary continence.
• History of recent surgical intervention or indicated for surgery for urinary incontinence.

Sponsors & Collaborators

• Suez Canal University: lead

Study Officials

• Abdelrhman Alshawadfy

  Faculty of Medicine, Suez Canal University Ismailia, , Egypt

  STUDY DIRECTOR

Central Study Contacts

Abdelrhman Alshawadfy, Professor

CONTACT

+201091091620; abdelrhmanalshawadfy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisstant Professor

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 23, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share