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

• Sponsor: Istanbul University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05391425
• Collaborator: Arnavutkoy State Hospital (Other)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urge Incontinence; Urgency-frequency Syndrome	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 Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Effect of Solifenacin Used for Lower Urinary Tract Symptoms on Sexual Function in Premenopausal vs Postmenopausal Women: A Prospective Observational Study
• Actual Study Start Date: Jun 3, 2021
• Anticipated Primary Completion Date: Jun 3, 2023
• Anticipated Study Completion Date: Jun 3, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arnavutkoy State Hospital	Istanbul	Arnavutkoy	Turkey	34275

Sponsors and Collaborators

• Istanbul University
• Arnavutkoy State Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: inci sema tas, MD, Istanbul University
• ClinicalTrials.gov Identifier: NCT05391425
• Other Study ID Numbers: solifenacinpm
• First Posted: May 26, 2022
• Last Update Posted: May 26, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by inci sema tas, MD, Istanbul University: urgency; urge urinary incontinence; solifenacin; sexual function; menopause; anticholinergic
• Additional relevant MeSH terms: Urinary Incontinence, Urge; Lower Urinary Tract Symptoms

Study Results

No Results Posted as of May 26, 2022