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

Additive Role of Low-intensity Extracorporeal Shock Wave Therapy to Kegel's Exercise in Management of Female Stress Urinary Incontinence : A Prospective Randomized Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Female Stress Urinary Incontinence
• Intervention / Treatment: Radiation: low-intensity extracorporeal shock (LiESWT); Behavioral: Kegel's exercises (KE)

Detailed Description

Many women believe that urinary incontinence is an inevitable part of aging or the aftermath of childbirth and do not seek treatment because of embarrassment or a lack of knowledge about available therapies.

The main underlying mechanism of SUI is the weakening of the pelvic floor muscles and connective tissues supporting the bladder and urethra. This structural compromise leads to urethral hypermobility and insufficient urethral closure during physical strain.

Risk factors include vaginal delivery, menopause, obesity, and chronic respiratory conditions.

Effective treatment targets these musculoskeletal deficits to restore continence and reduce leakage episodes.

Kegel's exercise (KE), also known as pelvic floor muscle training, is the first-line conservative treatment for SUI. It involves repetitive contractions and relaxations of pelvic floor muscles to improve their strength, endurance, and coordination.

Pelvic Floor Muscle Training (PFMT) has shown positive outcomes in reducing urinary leakage and improving quality of life. However, patient adherence, correct technique, and the chronicity of symptoms influence its effectiveness. In some cases, KE alone may not provide sufficient relief, especially in moderate to severe SUI.

Low-intensity extracorporeal shock wave therapy (LiESWT) is a non-invasive modality that uses acoustic waves to stimulate tissue regeneration, angiogenesis, and neuromuscular repair. Originally developed for urological and musculoskeletal disorders, its application has expanded to include female pelvic floor dysfunctions. LiESWT has shown promising results in improving urinary control by enhancing blood flow and tissue remodeling in the pelvic region.

Its safety, lack of anesthesia, and outpatient delivery make it an attractive complementary therapy.

The integration of LiESWT with KE is hypothesized to provide synergistic effects.

While Kegel's exercises strengthen muscle tone, LiESWT enhances vascular and cellular repair, potentially accelerating functional improvement. The combination targets both structural and physiological aspects of SUI. This dual approach may be especially beneficial for specific patients who have plateaued with PFMT alone or those seeking non-surgical alternatives with quicker results.

Recent studies have suggested that LiESWT can reduce urinary incontinence severity, but high-quality evidence, especially in combination with PFMT, remains limited. Most available research focuses either on LiESWT or KE separately.

There is a lack of comparative trials directly evaluating the additive benefit of combining both interventions in a structured treatment plan. Therefore, more comprehensive studies are required to determine whether the combination yields superior outcomes in terms of continence, patient satisfaction, and long-term efficacy.

A well-structured clinical comparison between combined LiESWT and KE versus Kegel's alone can fill an essential gap in SUI management. strategies. Such research can provide data on effectiveness, patient compliance, and functional outcomes. It can also guide clinicians on optimizing conservative treatment pathways before progressing to pharmacological or surgical options. Furthermore, evaluating cost-effectiveness and patient-reported outcomes can inform health policy and patient counseling.

The present study aims to assess the additive role of LiESWT to KE for female stress urinary incontinence.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdelrhman Alshawadfy, Professor; Phone Number: 002 +201091091620; Email: abdelrhmanalshawadfy@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-intensity extracorporeal shock (LiESWT) + Kegel's exercise (KE); 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); 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.; Behavioral: Kegel's exercises (KE); 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.
Active Comparator: Kegel's exercise (KE) only; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Frequency of leakage: 0 (Never) to 5 (All the time); Volume of leakage: 0 (None) to 6 (A large amount); 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	Change in quality of life, assessed by the Incontinence Quality of Life Questionnaire (I-QOL). The Incontinence Quality of Life Questionnaire (I-QOL) is a specific tool designed to assess the impact of urinary incontinence on an individual's quality of life. It consists of various items that evaluate how incontinence affects aspects such as emotional well-being, social interactions, and everyday activities. The Incontinence Quality of Life Questionnaire (I-QOL) scoring system generally ranges in total scores from 0 to 100. Minimum Value: 0 (indicating the lowest quality of life due to urinary incontinence) Maximum Value: 100 (indicating the highest quality of life with no impact from urinary incontinence)	Patients will be assessed at 4 weeks, 8 weeks, 12 weeks, and 3 months from the date of the intervention startup.

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Study Director: Abdelrhman Alshawadfy, Faculty of Medicine, Suez Canal University Ismailia, , Egypt

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: extracorporeal shock

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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