Overactive Bladder (OAB)Phase 4NCT07473310
Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women
A Phase 4 study testing Low intensity shockwave therapy and Oral Solifenacin succinate 5 mg in people with Overactive Bladder (OAB) and Urge Incontinence, run by Mansoura University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness and safety of low-intensity shockwave therapy (Li-SWT) for the treatment of overactive bladder (OAB) in adult women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder (OAB), Urge Incontinence
- What is being tested?
- Low intensity shockwave therapy and Oral Solifenacin succinate 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2025to Dec 2027
- Phase
- Phase 4
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OAB symptoms persisting for ≥3 months.
- OAB Symptom Score (OABSS) ≥7.
- Ability and willingness to provide informed consent
Who cannot join
- Active urinary tract infection.
- Stress urinary incontinence as primary diagnosis.
- Pelvic organ prolapse stage ≥II.
- History of pelvic radiation or surgery within 6 months.
- Use of anticholinergics or β3-agonists for the past 4 weeks who are unwilling to undergo washout.
- Pregnancy or breast feeding.
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- Neuropathic diseases or psychological disorders.
- History of urogenital malignancy.
- Uncontrolled DM (HbA1c > 6.8)
- Uncorrected coagulopathy or severe cardiovascular disease.
- Contraindication to solifenacin e.g.: closed angle glaucoma)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura Faculty of medicine
Al Mansurah, Dakahlia Governorate, 35111
About this study
Official title: Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate the effectiveness and safety of low-intensity shockwave therapy (Li-SWT) for the treatment of overactive bladder (OAB) in adult women.
The main questions this study aims to answer are whether Li-SWT improves overactive bladder symptoms and quality of life, and whether these improvements are sustained over a 12-month follow-up period, compared with standard medical therapy.
Read more
Researchers will compare Li-SWT with oral solifenacin succinate, a commonly used antimuscarinic medication for OAB.
Participants will be randomly assigned to receive either Li-SWT once weekly for 8 weeks or solifenacin 5 mg taken orally once daily for 12 months. All participants will complete symptom questionnaires and three-day voiding diaries and will undergo uroflowmetry, post-void residual measurement, and filling cystometry at specified time points during follow-up.
- Conditions
- Overactive Bladder (OAB), Urge Incontinence
- Being tested
- Low intensity shockwave therapy, Oral Solifenacin succinate 5 mg
- Keywords
- OAB, overactive bladder, low intensity shockwave, solifenacin
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity shockwave therapyOther
Participants will receive Li-SWT which will be applied once weekly for 8 weeks, with a focused shockwave. The bladder will be scanned by US to ensure that t is filled with approximately 50% of the maximum cytometric capacity as measure by baseline cystometry. The patients will be asked to lie flat in a supine position. The device will be operated by a well-trained urologist. A commercially used gel for sonography will be applied to suprapubic region. The applicator will be applied to the S.P region in 3 horizontal sites. 2 cm from each other and 2 fingerbreadths above the pubic bone with 45° tilt.
Li-SWT will be applied with energy density of 0.12 mJ/mm² and frequency of 4 pulses/second for a total of 3000 pulses per session (1000 pulses per bladder dome and each lateral wall at 45° tilt).
Oral Solifenacin succinate 5 mgDrug
Participants will receive solifenacin succinate 5 orally once daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| LiSWT group | Experimental | Allocated to receive LiSWT Receives: Other: Low intensity shockwave therapy |
| Solifenacin Group | Active comparator | Allocated to receive oral Solifenacin succinate 5 mg Receives: Drug: Oral Solifenacin succinate 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Overactive Bladder Symptom Score (OABSS) from baseline to different points of follow up
self administered questionnaire with minimum score of 0 and maximum score of 15, higher score means worse symptoms
Measured: Baseline and 3 months
Secondary outcomes (6)
Changes in frequency on three-day urinary diary
Changes in the mean number of voiding episodes per days as measure by a self administered three-day urinary diary
Measured: from baseline to 1, 3, 6,9 and 12 months
Changes in number of urgency episodes on three-day urinary diary
Changes in the mean number of urgency episodes per day (strong desire to void that cannot be postponed or withheld) as measured by a self administered three-day voiding diary
Measured: baseline to 1, 2, 3,6,9 and 12 months
Changes in number of nocturia episodes on three-day urinary diary
changes in the mean number of nocturia episodes per night(waking up in the middle of the night to void) as measured by a self-administered three-day voiding diary
Measured: baseline to 1, 2, 3,6,9 and 12 months
Changes in number of incontinence episodes on three-day urinary diary
Changes in number of incontinence episodes per day (involuntary leakage of urine) as measured by a self administered three-day urinary diary
Measured: form baseline to 1,2,3,6,9 and 12 months
changes in International Consultation on Incontinence Questionnaire- Urinary Incontinence-Short Form (ICIQ-UI-SF) score
self administered questionnaire with minimum score of 0 and maximum score of 21, the higher score, the worse the symptoms
Measured: form baseline to 1,2,3,6,9 and 12 months
changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol)
self administered questionnaire with minimum score of 25 and maximum score of 160 , higher score indicated worse effect on the quality of life
Measured: from baseline to 1,2,3,6,9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start11 Nov 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- More trials run by Mansoura 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473310
- Sponsor's protocol ID
- MD.25.08.1022
- Status last verified
- Mar 2026
- First submitted
- 27 Dec 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07473310
- Acronym / sponsor ID
- MD.25.08.1022
- Conditions
- Overactive Bladder (OAB), Urge Incontinence
- Keywords
- OAB, overactive bladder, low intensity shockwave, solifenacin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Mar 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.
The goal of this clinical trial is to evaluate the effectiveness and safety of low-intensity shockwave therapy (Li-SWT) for the treatment of overactive bladder (OAB) in adult women.
The main questions this study aims to answer are whether Li-SWT improves overactive bladder symptoms and quality of life, and whether these improvements are sustained over a 12-month follow-up period, compared with standard medical therapy.
Researchers will compare Li-SWT with oral solifenacin succinate, a commonly used antimuscarinic medication for OAB.
Participants will be randomly assigned to receive either Li-SWT once weekly for 8 weeks or solifenacin 5 mg taken orally once daily for 12 months. All participants will complete symptom questionnaires and three-day voiding diaries and will undergo uroflowmetry, post-void residual measurement, and filling cystometry at specified time points during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LiSWT group | Experimental | Other: Low intensity shockwave therapyAllocated to receive LiSWT |
| Solifenacin Group | Active comparator | Drug: Oral Solifenacin succinate 5 mgAllocated to receive oral Solifenacin succinate 5 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- OAB symptoms persisting for ≥3 months.
- OAB Symptom Score (OABSS) ≥7.
- Ability and willingness to provide informed consent
Key exclusion criteria (11 listed)
- Active urinary tract infection.
- Stress urinary incontinence as primary diagnosis.
- Pelvic organ prolapse stage ≥II.
- History of pelvic radiation or surgery within 6 months.
- Use of anticholinergics or β3-agonists for the past 4 weeks who are unwilling to undergo washout.
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 shockwave therapyParticipants will receive Li-SWT which will be applied once weekly for 8 weeks, with a focused shockwave. The bladder will be scanned by US to ensure that t is filled with approximately 50% of the maximum cytometric capacity as measure by baseline cystometry. The patients will be asked to lie flat in a supine position. The device will be operated by a well-trained urologist. A commercially used gel for sonography will be applied to suprapubic region. The applicator will be applied to the S.P region in 3 horizontal sites. 2 cm from each other and 2 fingerbreadths above the pubic bone with 45° tilt. Li-SWT will be applied with energy density of 0.12 mJ/mm² and frequency of 4 pulses/second for a total of 3000 pulses per session (1000 pulses per bladder dome and each lateral wall at 45° tilt). | Other | LiSWT group |
| Oral Solifenacin succinate 5 mgParticipants will receive solifenacin succinate 5 orally once daily for 12 months | Drug | Solifenacin Group |
Primary outcome
Changes in Overactive Bladder Symptom Score (OABSS) from baseline to different points of follow up
Time frame: Baseline and 3 months
self administered questionnaire with minimum score of 0 and maximum score of 15, higher score means worse symptoms
6 secondary outcomes
Changes in frequency on three-day urinary diary
Time frame: from baseline to 1, 3, 6,9 and 12 months
Changes in number of urgency episodes on three-day urinary diary
Time frame: baseline to 1, 2, 3,6,9 and 12 months
Changes in number of nocturia episodes on three-day urinary diary
Time frame: baseline to 1, 2, 3,6,9 and 12 months
Changes in number of incontinence episodes on three-day urinary diary
Time frame: form baseline to 1,2,3,6,9 and 12 months
changes in International Consultation on Incontinence Questionnaire- Urinary Incontinence-Short Form (ICIQ-UI-SF) score
Time frame: form baseline to 1,2,3,6,9 and 12 months
changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol)
Time frame: from baseline to 1,2,3,6,9 and 12 months
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 16 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low intensity shockwave therapy and Oral Solifenacin succinate 5 mg in people with Overactive Bladder (OAB) and Urge Incontinence, run by Mansoura University at 1 site in Egypt.
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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yahya H Elmorsy (00201100311999, Hossam.Yahya@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Overactive Bladder Symptom Score (OABSS) from baseline to different points of follow up (time frame: Baseline and 3 months). 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 16 Mar 2026.