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

NCT ID: NCT05391425

Last Updated: 2022-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-03

Study Completion Date

2024-06-03

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.

Conditions

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Urge Incontinence Urgency-frequency Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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premenopausal

Premenopausal patients, presented in Arnavutkoy State Hospital Gynecology Clinic with lower urinary tract symptoms that will be treated with Solifenacin (Vesicare 5mg).

no intervention

Intervention Type OTHER

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).

no intervention

Intervention Type OTHER

no intervention planned, since it is an observational study

Interventions

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no intervention

no intervention planned, since it is an observational study

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Arnavutkoy State Hospital

OTHER

Sponsor Role collaborator

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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inci sema tas

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Arnavutkoy State Hospital

Istanbul, Arnavutkoy, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Inci Sema Tas, MD

Role: CONTACT

00905359509232

Facility Contacts

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Inci Sema Tas, MD

Role: primary

00905359509232

Other Identifiers

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solifenacinpm

Identifier Type: -

Identifier Source: org_study_id

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