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.
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)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- 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.
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.
- Conditions
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Kegel's exercises (KE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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)
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.
- First posted23 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
- Investigators
- Abdelrhman Alshawadfy, Study director, Faculty of Medicine, Suez Canal University Ismailia, , Egypt
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07663968
- Acronym / sponsor ID
- extracorporeal shock
- Conditions
- Female Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-intensity extracorporeal shock (LiESWT) + Kegel's exercise (KE) | Active comparator | Radiation: low-intensity extracorporeal shock (LiESWT), Behavioral: Kegel's exercises (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. |
| Kegel's exercise (KE) only | Active comparator | 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Low-intensity extracorporeal shock (LiESWT) + Kegel's exercise (KE) |
| 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. | Behavioural | Kegel's exercise (KE) only, Low-intensity extracorporeal shock (LiESWT) + Kegel's exercise (KE) |
Primary outcome
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.
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.
1 secondary outcome
Change in quality of life
Time frame: Patients will be assessed at 4 weeks, 8 weeks, 12 weeks, and 3 months from the date of the intervention startup.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abdelrhman Alshawadfy study director
Faculty of Medicine, Suez Canal University Ismailia, , Egypt
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.