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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05391425
Enrollment
150
Registered
2022-05-26
Start date
2021-06-03
Completion date
2024-06-03
Last updated
2022-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urge Incontinence, Urgency-frequency Syndrome

Keywords

urgency, urge urinary incontinence, solifenacin, sexual function, menopause, anticholinergic

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.

Interventions

OTHERno intervention

no intervention planned, since it is an observational study

Sponsors

Arnavutkoy State Hospital
CollaboratorOTHER
Istanbul University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
the effect of solifenasin used for lower urinary tract symptoms on sexual function6 monthsFemale Sexual Function Index (FSFI) scores change between in baseline, 3 and 6 months after Solifenacin use for lower urinary tract symptoms.
the effect of solifenasin used for lower urinary tract symptoms on sexual function in premenapausal vs postmenapausal women6 monthsThe 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

MeasureTime frameDescription
the effect of Solifenacin treatment for lower urinary tract symptoms (LUTS) on sexual function and its correleation with the improvement in LUTS3 and 6 monthsThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactInci Sema Tas, MD
incisematas@gmail.com00905359509232

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026