Urge IncontinenceNCT05391425
The Effect of Solifenacin Used for Lower Urinary Tract Symptoms on Sexual Function
An observational study of Urge Incontinence and Urgency-frequency Syndrome, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Urge Incontinence, Urgency-frequency Syndrome
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2021to 3 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Arnavutkoy State Hospital
Istanbul, Arnavutkoy, 34275
Inci Sema Tas, MD, 00905359509232, incisematas@gmail.com
Inci Sema Tas, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Urge Incontinence, Urgency-frequency Syndrome
- Being tested
- no intervention
- Keywords
- urgency, urge urinary incontinence, solifenacin, sexual function, menopause, anticholinergic
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention planned, since it is an observational study
| Study group | Role | What they receive |
|---|---|---|
| premenopausal | Premenopausal patients, presented in Arnavutkoy State Hospital Gynecology Clinic with lower urinary tract symptoms that will be treated with Solifenacin (Vesicare 5mg). Receives: 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). Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start3 Jun 2021
- Primary completion3 Jun 2023 (estimated)
- Study completion3 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urge IncontinenceStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Arnavutkoy State Hospital
- Responsible party
- Principal investigator, inci sema tas, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391425
- Sponsor's protocol ID
- solifenacinpm
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Solifenacin Used for Lower Urinary Tract Symptoms on Sexual Function in Premenopausal vs Postmenopausal Women: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05391425
- Acronym / sponsor ID
- solifenacinpm
- Conditions
- Urge Incontinence, Urgency-frequency Syndrome
- Keywords
- urgency, urge urinary incontinence, solifenacin, sexual function, menopause, anticholinergic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Arnavutkoy State Hospital
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 3 Jun 2023 (estimated)
- Study completion
- 3 Jun 2024 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| premenopausal | – | Other: no interventionPremenopausal patients, presented in Arnavutkoy State Hospital Gynecology Clinic with lower urinary tract symptoms that will be treated with Solifenacin (Vesicare 5mg). |
| postmenopausal | – | Other: no interventionPostmenopausal patients, presented in Arnavutkoy State Hospital Gynecology Clinic with lower urinary tract symptoms that will be treated with Solifenacin (Vesicare 5mg). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention planned, since it is an observational study | Other | postmenopausal, premenopausal |
Primary outcome
the effect of solifenasin used for lower urinary tract symptoms on sexual function
Time frame: 6 months
Female 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 women
Time frame: 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.
1 secondary outcome
the effect of Solifenacin treatment for lower urinary tract symptoms (LUTS) on sexual function and its correleation with the improvement in LUTS
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urge Incontinence and Urgency-frequency Syndrome, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inci Sema Tas, MD (00905359509232, incisematas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of solifenasin used for lower urinary tract symptoms on sexual function (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.