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Female Stress Urinary IncontinenceNCT07663968

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

A study testing low-intensity extracorporeal shock (LiESWT) and Kegel's exercises (KE) in people with Female Stress Urinary Incontinence, run by Suez Canal University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 60 years, women only
Conditions the study is for
Female Stress Urinary Incontinence
What is being tested?
low-intensity extracorporeal shock (LiESWT) and Kegel's exercises (KE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
No sites listed yet
Study dates
1 Jul 2026to 30 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Abdelrhman Alshawadfy, Professor contact

+201091091620 ext. 002

abdelrhmanalshawadfy@gmail.com

About this study

Official title: 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.

Read the 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.

Being tested
low-intensity extracorporeal shock (LiESWT), Kegel's exercises (KE)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Kegel's exercises (KE)Behavioural

    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.

Study groups in NCT07663968
Study groupRoleWhat they receive
Low-intensity extracorporeal shock (LiESWT) + Kegel's exercise (KE)Active comparatorReceives 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.
Receives: Radiation: low-intensity extracorporeal shock (LiESWT); Behavioral: Kegel's exercises (KE)
Kegel's exercise (KE) onlyActive comparatorDaily 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.
Receives: Behavioral: Kegel's exercises (KE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07663968
Sponsor's protocol ID
extracorporeal shock
Status last verified
Jun 2026
First submitted
11 Jun 2026
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing low-intensity extracorporeal shock (LiESWT) and Kegel's exercises (KE) in people with Female Stress Urinary Incontinence, run by Suez Canal University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abdelrhman Alshawadfy, Professor (+201091091620 ext. 002, abdelrhmanalshawadfy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in frequency and severity of stress urinary incontinence episodes (time frame: Patients will be assessed at 4 weeks, 8 weeks, 12 weeks, and 3 months from the date of the intervention startup.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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