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

Urge Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391425
• Other study ID #: solifenacinpm
• Status: Recruiting
• Start date: June 3, 2021
• Est. completion date: June 3, 2024

Study information

• Verified date: May 2022
• Source: Istanbul University
• Contact: Inci Sema Tas, MD
• Phone: 00905359509232
• Email: incisematas[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 3, 2024
• Est. primary completion date: June 3, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Urge Incontinence
• Urgency-frequency Syndrome
• Urinary Incontinence, Urge

Intervention

Other:
• no intervention
no intervention planned, since it is an observational study

Locations

Country	Name	City	State
Turkey	Arnavutkoy State Hospital	Istanbul	Arnavutkoy

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University	Arnavutkoy State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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