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| Name | Class |
|---|---|
| Cairo University | OTHER |
| Ain Shams University | OTHER |
| Alexandria University | OTHER |
| Zagazig University |
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Researchers are studying two medicines to see which works better for women with overactive bladder (OAB). OAB causes sudden urges to urinate, frequent bathroom trips, and sometimes leakage.
Women who join the study will be randomly placed into one of two groups:
One group will take tadalafil (5 mg), a medicine taken once a day.
The other group will take solifenacin (5 mg), a common treatment for OAB, also taken once a day.
The study will last 12 weeks. Participants will keep a bladder diary, answer short questionnaires, and have simple urine flow and bladder tests at several visits.
The main goal is to find out which medicine lowers OAB symptoms more, such as urgency and frequent urination. Researchers will also look at quality of life, bladder function, and side effects.
Women aged 18 to 75 years with OAB symptoms for at least 3 months may be able to take part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1, Low dose Tadalafil group | Experimental | Participants will receive tadalafil 5 mg orally once daily for the duration of 12 weeks |
|
| Group 2: Solifenacin Group | Active Comparator | Participants will receive solifenacin succinate 5 mg orally once daily for the duration of 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil 5 mg | Drug | Tadalafil 5 mg orally once daily for the duration of 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overactive Bladder Symptom Score percentage reduction | self administered questionnaire with minimum score of 0 and maximum score of 15, higher score means worse symptoms. Three points reduction in the total OABSS is determined as the minimal threshold for a meaningful change | from enrollment to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in frequnecy episodes in three-day voiding diary | Changes in the mean number of voiding episodes per days as measure by a self administered three-day urinary diary | from enrollment to follow up visits at 4,8 and 12 weeks |
| changes in International Consultation on Incontinence Questionnaire- Urinary Incontinence-Short Form (ICIQ-UI-SF) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Hegazy, M.D of Urology | Contact | +201028299216 | mhalem88@yahoo.com | |
| Yahya H ElMorsy, MSc of Urology | Contact | +201100311999 | hossam.yahya@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed A Shokeir, professor of urology | Urology & Nephrology Center, Masnoura university, Egypt | Study Director |
| Sherif Mourad, Professor of Urology | Ain Shams University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine, Menofia Univeristy | Recruiting | Shibīn al Kawm | Al-Minūfiyyah | Egypt |
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| OTHER_GOV |
| Tanta University | OTHER |
| Menoufia University | OTHER |
| Assiut University | OTHER |
| Sohag University | OTHER |
| South Valley University | OTHER |
| Beni-Suef University | OTHER |
| Minia University | OTHER |
| Aswan University | OTHER |
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| Solifenacin 5mg | Drug | solifenacin succinate 5 mg orally once daily for the duration of 12 weeks |
|
self administered questionnaire with minimum score of 0 and maximum score of 21, the higher score, the worse the symptoms |
| from enrollment to follow up visits at 4,8 and 12 weeks |
| changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol) | elf administered questionnaire with minimum score of 25 and maximum score of 160 , higher score indicated worse effect on the quality of life | All follow up visits at 4, 8, and 12 weeks |
| 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 | from enrollment to follow up visits at 4,8 and 12 weeks |
| 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 | from enrollment to follow up visits at 4,8 and 12 weeks |
| Changes in number of incontinence episodes on three-day voiding diary | Changes in number of incontinence episodes per day (involuntary leakage of urine) as measured by a self administered three-day urinary diary | from enrollment to follow up visits at 4,8 and 12 weeks |
| Faculty of medicine, Zagazig University | Recruiting | Zagazig | Al-Sharqia | Egypt |
|
| Urology and Nephrology Center, Mansoura University | Recruiting | Al Mansurah | Dakahlia Governorate | 35516 | Egypt |
|
| Faculty of medicine, Tanta University | Recruiting | Tanta | Gharbia Governorate | Egypt |
|
| faulty of medicine, Tanta Univeristy | Recruiting | Tanta | Gharbia Governorate | Egypt |
|
| Faculty of medicine, minia university | Recruiting | Al Minyā | Egypt |
|
| Faculty of medicine, Alexandria University | Recruiting | Alexandria | Egypt |
|
| Faculty of medicine, Aswan university | Recruiting | Aswān | Egypt |
|
| Faculty of Medicine - Assiut University | Recruiting | Asyut | Egypt |
|
| Faculty of Medicine - Banī Suwayf University | Recruiting | Banī Suwayf | Egypt |
|
| Faculty of medicine, Ain Shams University | Recruiting | Cairo | 1181 | Egypt |
|
| Cairo University, faculty of medicine | Recruiting | Cairo | 1211 | Egypt |
|
| Faculty of Medicine, South Valley University | Recruiting | Qina | Egypt |
|
| Faculty of medicine, Sohag Univeristy | Recruiting | Sohag | Egypt |
|
| 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 |
| 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 |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
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