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

• Conditions: Urge Incontinence; Urgency-frequency Syndrome
• Interventions: Other: no intervention

• Registration Number: NCT05391425
• Lead Sponsor: Istanbul University

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-06-03
• Status Verified: 2022-05
• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-20
• Last Update Submitted: 2022-05-20
• Study First Posted: 2022-05-26
• Last Update Posted: 2022-05-26
• Primary Completion: 2023-06-03
• Study Completion: 2024-06-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
postmenopausal	no intervention	Postmenopausal patients, presented in Arnavutkoy State Hospital Gynecology Clinic with lower urinary tract symptoms that will be treated with Solifenacin (Vesicare 5mg).
premenopausal	no intervention	Premenopausal patients, presented in Arnavutkoy State Hospital Gynecology Clinic with lower urinary tract symptoms that will be treated with Solifenacin (Vesicare 5mg).

Primary Outcome Measures

Name	Time	Method
the effect of solifenasin used for lower urinary tract symptoms on sexual function in premenapausal vs postmenapausal women	6 months	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.
the effect of solifenasin used for lower urinary tract symptoms on sexual function	6 months	Female Sexual Function Index (FSFI) scores change between in baseline, 3 and 6 months after Solifenacin use for lower urinary tract symptoms.

Secondary Outcome Measures

Name	Time	Method
the effect of Solifenacin treatment for lower urinary tract symptoms (LUTS) on sexual function and its correleation with the improvement in LUTS	3 and 6 months	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.

Trial Locations

Locations (1)

Arnavutkoy State Hospital; 🇹🇷 Istanbul, Arnavutkoy, Turkey