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This study will include women who will undergo pelvic reconstructive surgery and/or anti-incontinence sling procedures. Patients will be randomized to the combination of L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract in tablet or placebo twice a day during the seven days before and after surgery (total of 14 days). In this randomized, double-blind study, the investigators will assess treatment of clinically suspected or culture-proven urinary tract infections within 3 weeks of surgery (primary outcome), and risk factors for treatment for postoperative urinary tract infections (secondary outcomes) between the two study groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract | Active Comparator | The combination of L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract will be administered in tablet twice a day 7 days before and after surgery |
|
| Placebo | Placebo Comparator | Placebo tablet twice a day 7 days before and after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract | Drug | L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract tablet twice a day 7 days before and after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment for urinary tract infection after surgery. | To assess any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery. | 3 weeks after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Umberto Leone Roberti Maggiore, MD | IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University | Principal Investigator |
| Stefano Salvatore, MD | IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University | Milan | Lombardy | 20100 | Italy |
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| Placebo | Other | Placebo tablet twice a day 7 days before and after surgery |
|
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D056887 | Pelvic Organ Prolapse |
| D014549 | Urinary Incontinence |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008715 | Methionine |
| ID | Term |
|---|---|
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000601 | Amino Acids, Essential |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D021542 | Amino Acids, Neutral |
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