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

NCT05391425 | Unknown DMC

• 1 other identifier: solifenacinpm
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Urge Incontinence; Urgency-frequency Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (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

Study Arms (2)

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

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

Interventions

no intervention OTHER

no intervention planned, since it is an observational study

postmenopausal; premenopausal

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead
• Arnavutkoy State Hospital: collaborator

Study Sites (1)

Arnavutkoy State Hospital

Istanbul, Arnavutkoy, 34275, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Inci Sema Tas, MD

CONTACT

00905359509232; incisematas@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 26, 2022
• Study Start: June 3, 2021
• Primary Completion: June 3, 2023
• Study Completion: June 3, 2024
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

TU (1)