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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urge Incontinence; Urgency-frequency Syndrome
• Intervention / Treatment: Other: no intervention

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Inci Sema Tas, MD; Phone Number: 00905359509232; Email: incisematas@gmail.com

Study Locations

• Turkey
  • Arnavutkoy
    • Istanbul, Arnavutkoy, Turkey, 34275
      • Recruiting
      • Arnavutkoy State Hospital
      • Contact: Inci Sema Tas, MD; Phone Number: 00905359509232; Email: incisematas@gmail.com
      • Principal Investigator: Inci Sema Tas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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) are enrolled in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
premenopausal; 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; no intervention planned, since it is an observational study
postmenopausal; 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; no intervention planned, since it is an observational study

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul University
• Collaborators: Arnavutkoy State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Anticipated): June 3, 2023
• Study Completion (Anticipated): June 3, 2024

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: menopause; sexual function; solifenacin; urgency; urge urinary incontinence; anticholinergic
• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Urination Disorders; Urinary Incontinence; Lower Urinary Tract Symptoms; Urinary Incontinence, Urge
• Other Study ID Numbers: solifenacinpm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No