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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LiSWT group | Experimental | Allocated to receive LiSWT |
|
| Solifenacin Group | Active Comparator | Allocated to receive oral Solifenacin succinate 5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity shockwave therapy | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from baseline to 1, 3, 6,9 and 12 months |
| Changes in number of urgency episodes on three-day urinary diary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yahya H Elmorsy | Contact | 00201100311999 | Hossam.Yahya@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura Faculty of medicine | Recruiting | Al Mansurah | Dakahlia Governorate | 35111 | Egypt |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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|
| Oral Solifenacin succinate 5 mg | Drug | Participants will receive solifenacin succinate 5 orally once daily for 12 months |
|
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 |
| 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 | 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 | 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 | 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 | from baseline to 1,2,3,6,9 and 12 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |