The Effect of Solifenacin Used for Lower Urinary Tract Symptoms on Sexual Function

Study Overview
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Brief Summary
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This study aims to determine whether Solifenacine used for lower urinary tract symptoms improves sexual function and if so does this improvement differs between premenopausal and postmenopausal women.

Detailed Description
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Solifenacin is an anticholinergic drug that is commonly used for lower urinary tract symptoms such as urgency, frequency and urge urinary incontinence. Solifenacin use and sexual function improvement is presented in some research, but the correlation between the improvement in sexual function and LUTS symptoms is yet not investigated. Also the effect on sexual function in premenopausal vs postmenopausal women are unknown.

Official Title
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The Effect of Solifenacin Used for Lower Urinary Tract Symptoms on Sexual Function in Premenopausal vs Postmenopausal Women: A Prospective Observational Study

Conditions
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Urge Incontinence, Urgency-frequency Syndrome

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women presented in Arnavutkoy State Hospital Gynecology Clinic with lower urinary tract symptoms that are planned to start treatment with Solifenacin 5 mg (Vesicare 5mg). Patients agreed to involve in the study, having discussed other treatment options and possible side effects of the medication. Informed consent obtained Exclusion Criteria: urinary tract infection stress urinary incontinence urinary retention grade 2 or above pelvic organ prolapse according to POP-Q scale Solifenacin contraindications such as narrow angle glaucoma, allergy of Solifenacin or other components of the drug.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| premenopausal<br>Premenopausal patients, presented in Arnavutkoy State Hospital Gynecology Clinic with lower urinary tract symptoms that will be treated with Solifenacin (Vesicare 5mg). | Other: no intervention<br>* no intervention planned, since it is an observational study<br>|
| postmenopausal<br>Postmenopausal patients, presented in Arnavutkoy State Hospital Gynecology Clinic with lower urinary tract symptoms that will be treated with Solifenacin (Vesicare 5mg). | Other: no intervention<br>* no intervention planned, since it is an observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect of solifenasin used for lower urinary tract symptoms on sexual function | Female Sexual Function Index (FSFI) scores change between in baseline, 3 and 6 months after Solifenacin use for lower urinary tract symptoms. | 6 months | 
| the effect of solifenasin used for lower urinary tract symptoms on sexual function in premenapausal vs postmenapausal women | The aim of this study is to determine whether Solifenacine used for lower urinary tract symptoms improve sexual function (measured by Female Sexual Function Index; higher scores meaning sexual dysfunction with the cut off value of 26.) and if so does this improvement differs between premenaupausal and postmenaupausal women. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect of Solifenacin treatment for lower urinary tract symptoms (LUTS) on sexual function and its correleation with the improvement in LUTS | The aim of this study is to determine whether Solifenacine used for lower urinary tract symptoms improve sexual function (measured by Female Sexual Function Index; higher scores meaning sexual dysfunction with the cut off value 26.)and if so does this correlates with the improvement with lower urinary tract disorders. | 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urgency, urge urinary incontinence, solifenacin, sexual function, menopause, anticholinergic