Urinary IncontinenceVACS-D: FuSNCT07483138
VACS Device Clinical Study for Incontinence Treatment: Follow up Study
An observational study of Urinary Incontinence, run by Soranus ArGe ve Danismanlik Hizmetleri Sanayi Ticaret A.S. at 2 sites in Turkey (Türkiye).
Trial summary
Stress Urinary Incontinence (SUI) is a common health condition in the female population. Mid-urethral slings (MUS) have proven to be effective in the treatment of female SUI. Trans-obturator tape (TOT) has been demonstrated to be as effective as retropubic tension-free vaginal tape (TVT) with fewer major… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Urinary Incontinence
- How many people
- 36 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 4 Feb 2025to 10 Mar 2026
- How long will I take part?
- 36 Months
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who participated in the study titled "Clinical Evaluation of Vaginal Suture Knotting Device in the Treatment of Urinary Incontinence in Women" (protocol code VACS-D) and completed their final follow-up visit (the 6-12-month visit).
Who may be able to join
- Patients who participated in the study titled "Clinical Evaluation of Vaginal Suture Knotting Device in the Treatment of Urinary Incontinence in Women" (protocol code VACS-D) and completed their final follow-up visit (the 6-12-month visit).
- Volunteers who are willing to participate, have been informed about the study, and have provided a signed informed consent form (ICF), stating that they can comply with the requirements and restrictions listed in the ICF and this protocol.
Who cannot join
- Having received radiotherapy during the postoperative period as part of the VACS-D study.
- Women who are pregnant based on the results of a urine pregnancy test.
- Those who have been enrolled in any other clinical trial following the VACS-D protocol study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Department of Gynecology and Obstetrics, Department of Surgical Medical Sciences, Istanbul Faculty of Medicine
Istanbul, 34093
Ege University Faculty of Medicine, Department of Obstetrics and Gynecology
Izmir, 35100
About this study
Official title: Clinical Evaluation of Vaginal Suture Knotting Device in the Treatment of Urinary Incontinence in Women: Long-term Follow-up Study
Stress Urinary Incontinence (SUI) is a common health condition in the female population. Mid-urethral slings (MUS) have proven to be effective in the treatment of female SUI. Trans-obturator tape (TOT) has been demonstrated to be as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. In this study, the aim is an evaluation of the efficacy of vacs-minifiks in the surgical treatment of stress urinary ıncontinence 24 months post-operatively.
Read the detailed description
For this planned follow-up study, 57 patients (28 VACS-D and 29 TOT patients) who had been enrolled in the study designated as VACS-D-which was completed in October 2023 in accordance with the study protocol-and who had completed their final follow-up visits (the 6-12-month follow-up visit) were invited to participate. Those volunteers who agreed to participate were included in this study.
The study was designed to include a single visit. During this visit, the patients' medical histories were taken. Body weight measurements will be taken, and volunteers will be asked to complete certain questionnaires/surveys to assess their quality of life, sexual function, and treatment satisfaction (Incontinence Quality of Life Scale (I-QOL), Female Sexual Function Index (FSFI), Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6), Overactive Bladder Questionnaire (OAB-V8), Urinary Sympthomatic Questionnaire, and Short Form of Patient Satisfaction Assessment (PSS) to assess their quality of life, sexual function, and treatment satisfaction.
In addition to these, post-void residual urine volume (PVR) measurements will be performed via ultrasound. Furthermore, volunteers were asked to keep a three-day bladder diary.
If there were findings suggesting a urinary tract infection, a complete urinalysis was performed; if deemed necessary by the physician, a Urine Culture and Antibiogram test was also conducted.
Volunteers in whom a urinary tract infection was detected during the study visit were evaluated after completing treatment for the infection.
Information was recorded for patients who received incontinence treatment and/or underwent incontinence surgery during the postoperative period. Statistical analysis was performed.
- Conditions
- Urinary Incontinence
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VACS-D | During the surgical procedure, this group operated with VACS-Minifiks. | |
| TOT | During the surgical procedure, this group operated with the commercially available Transobturator Tape (TOT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-Hour Pad Testing
This test is performed in a clinical setting. They include a filling phase, during which the patient spends 15 minutes drinking 500 ml of fluid. This is followed by a series of provocative maneuvers, such as coughing and jumping, to try to stimulate urinary leakage. Pads are weighed before and at the end of the test. Pad loss ≥ 2 g is designated as significant or a 'positive pad test.
Measured: after 24 months
Evaluation of Quality of Life
The Incontinence Quality of Life Scale (I-QOL), consisting of 22 questions, was used to analyze the improvement in quality of life. It is a validated questionnaire. Higher scores indicate a better level of quality of life compared to lower scores.
Measured: after 24 months
Cough Stress Test
A cough stress test (CST) is a simple, non-invasive diagnostic procedure used, primarily in women, to identify stress urinary incontinence (SUI). During the test, a patient with a comfortably full bladder coughs or strains while a healthcare provider directly observes for urine leakage, which confirms the diagnosis.
Measured: after 24 months
Secondary outcomes (6)
Symptomatic Assessment for Overactive Bladder
Overactive Bladder Questionnaire (OAB-V8), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. A higher score means a worse outcome. Meaningful for patients. It is standardized. The patient's daily activities are taken into account.
Measured: after 24 months
Assess the Impact of the Dysfunction on Quality of Life
Urogenital Distress Inventory (UDI-6), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. A lesser score means a better outcome. Meaningful for patients. It is standardized. The patient's daily activities are taken into account.
Measured: after 24 months
Symptomatic Impact Assessment
Incontinence Impact Questionnaire (IIQ-7), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. A lesser score means a better outcome. Meaningful for patients. It is standardized.
Measured: after 24 months
Assessment of Sexual Function
It was used for impact on sexual function using the Female Sexual Function Inventory (FSFI), a validated, gender-specific measure of sexual function.
Measured: after 24 months
Assessment of Sexual Function during Intercourse
Coital Incontinence Questionnaire (CIQ) is a validated, gender-specific measure of sexual function. It was used for the impact on sexual function during Intercourse.
Measured: after 24 months
Post-Voiding Residual (PVR) Urine Volume
Volume: Since the device has the potential to affect bladder emptying, measurement of PVR and clinical significance are important. PVR volume will be measured with a catheter as per standardization and an abnormal value above 100 ml will be accepted.
Measured: after 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start4 Feb 2025
- Primary completion25 Dec 2025
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 36 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Soranus ArGe ve Danismanlik Hizmetleri Sanayi Ticaret A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cenk Yasa, Professor, Principal investigator, Istanbul Faculty of Medicine, Department of Obstetrics and GynecologyGokay Ozceltik, Principal investigator, Ege University Faculty of Medicine Department of Obstetrics and GynecologyOzgur Yeniel, Study director, Ege University Faculty of Medicine Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483138
- Sponsor's protocol ID
- VACS-D 002
- Acronym
- VACS-D: FuS
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Vaginal Suture Knotting Device in the Treatment of Urinary Incontinence in Women: Long-term Follow-up Study
- ClinicalTrials.gov ID
- NCT07483138
- Acronym / sponsor ID
- VACS-D: FuS / VACS-D 002
- Conditions
- Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Soranus ArGe ve Danismanlik Hizmetleri Sanayi Ticaret A.S.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 19 Mar 2026 (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.
Stress Urinary Incontinence (SUI) is a common health condition in the female population. Mid-urethral slings (MUS) have proven to be effective in the treatment of female SUI. Trans-obturator tape (TOT) has been demonstrated to be as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. In this study, the aim is an evaluation of the efficacy of vacs-minifiks in the surgical treatment of stress urinary ıncontinence 24 months post-operatively.
Detailed description
For this planned follow-up study, 57 patients (28 VACS-D and 29 TOT patients) who had been enrolled in the study designated as VACS-D-which was completed in October 2023 in accordance with the study protocol-and who had completed their final follow-up visits (the 6-12-month follow-up visit) were invited to participate. Those volunteers who agreed to participate were included in this study.
The study was designed to include a single visit. During this visit, the patients' medical histories were taken. Body weight measurements will be taken, and volunteers will be asked to complete certain questionnaires/surveys to assess their quality of life, sexual function, and treatment satisfaction (Incontinence Quality of Life Scale (I-QOL), Female Sexual Function Index (FSFI), Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6), Overactive Bladder Questionnaire (OAB-V8), Urinary Sympthomatic Questionnaire, and Short Form of Patient Satisfaction Assessment (PSS) to assess their quality of life, sexual function, and treatment satisfaction.
In addition to these, post-void residual urine volume (PVR) measurements will be performed via ultrasound. Furthermore, volunteers were asked to keep a three-day bladder diary.
If there were findings suggesting a urinary tract infection, a complete urinalysis was performed; if deemed necessary by the physician, a Urine Culture and Antibiogram test was also conducted.
Volunteers in whom a urinary tract infection was detected during the study visit were evaluated after completing treatment for the infection.
Information was recorded for patients who received incontinence treatment and/or underwent incontinence surgery during the postoperative period. Statistical analysis was performed.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VACS-D | – | –During the surgical procedure, this group operated with VACS-Minifiks. |
| TOT | – | –During the surgical procedure, this group operated with the commercially available Transobturator Tape (TOT). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who participated in the study titled "Clinical Evaluation of Vaginal Suture Knotting Device in the Treatment of Urinary Incontinence in Women" (protocol code VACS-D) and completed their final follow-up visit (the 6-12-month visit).
Key inclusion criteria (2 listed)
- Patients who participated in the study titled "Clinical Evaluation of Vaginal Suture Knotting Device in the Treatment of Urinary Incontinence in Women" (protocol code VACS-D) and completed their final follow-up visit (the 6-12-month visit).
- Volunteers who are willing to participate, have been informed about the study, and have provided a signed informed consent form (ICF), stating that they can comply with the requirements and restrictions listed in the ICF and this protocol.
Key exclusion criteria (3 listed)
- Having received radiotherapy during the postoperative period as part of the VACS-D study.
- Women who are pregnant based on the results of a urine pregnancy test.
- Those who have been enrolled in any other clinical trial following the VACS-D protocol study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
One-Hour Pad Testing
Time frame: after 24 months
This test is performed in a clinical setting. They include a filling phase, during which the patient spends 15 minutes drinking 500 ml of fluid. This is followed by a series of provocative maneuvers, such as coughing and jumping, to try to stimulate urinary leakage. Pads are weighed before and at the end of the test. Pad loss ≥ 2 g is designated as significant or a 'positive pad test.
Evaluation of Quality of Life
Time frame: after 24 months
The Incontinence Quality of Life Scale (I-QOL), consisting of 22 questions, was used to analyze the improvement in quality of life. It is a validated questionnaire. Higher scores indicate a better level of quality of life compared to lower scores.
Cough Stress Test
Time frame: after 24 months
A cough stress test (CST) is a simple, non-invasive diagnostic procedure used, primarily in women, to identify stress urinary incontinence (SUI). During the test, a patient with a comfortably full bladder coughs or strains while a healthcare provider directly observes for urine leakage, which confirms the diagnosis.
6 secondary outcomes
Symptomatic Assessment for Overactive Bladder
Time frame: after 24 months
Assess the Impact of the Dysfunction on Quality of Life
Time frame: after 24 months
Symptomatic Impact Assessment
Time frame: after 24 months
Assessment of Sexual Function
Time frame: after 24 months
Assessment of Sexual Function during Intercourse
Time frame: after 24 months
Post-Voiding Residual (PVR) Urine Volume
Time frame: after 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No. Data available from the corresponding author upon reasonable request.
Related trials for Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
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Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
Urinary Incontinence (UI)
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
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.
Cenk Yasa, Professor principal investigator
Istanbul Faculty of Medicine, Department of Obstetrics and Gynecology
Gokay Ozceltik principal investigator
Ege University Faculty of Medicine Department of Obstetrics and Gynecology
Ozgur Yeniel study director
Ege University Faculty of Medicine Department of Obstetrics and Gynecology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by Soranus ArGe ve Danismanlik Hizmetleri Sanayi Ticaret A.S. at 2 sites 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-Hour Pad Testing (time frame: after 24 months). The study lists 3 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 19 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.