Urinary IncontinenceVACS-DNCT06173180
VACS Device Clinical Study for Incontinence Treatment
A study testing TOT and VACS-D in people with 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
- What is being tested?
- TOT and VACS-D
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 7 Jan 2022to 6 Oct 2023
- Phase
- Interventional
- 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
Who may be able to join
- Those who have not received radiotherapy
- Women aged 40-65 years
- Accompanying infection according to urine culture results people who do not
- Informed about the study and participated in the study patients who have agreed to participate
- Acceptable contraception during work agree to continue to apply their methods those who
- According to the urodynamic test results, the researcher appropriate to be included in the study by patients with
- After physical and neurological examination inclusion in the study was made by the researcher. eligible patients
- Previous response to standard treatments (medication, etc.) non-responders (non-responders to methods such as pelvic floor muscle exercises (with or without physical therapy), behavioral and lifestyle modifications, continence-assisted pessaries, and pharmacotherapy)
Who cannot join
- Women who are pregnant, supported by biochemical laboratory findings
- Those in the urinary incontinence category other than SUI
- Those with significant pelvic organ prolapse (e.g., cystocele, rectocele); (as defined by the International Continence Society greater than phase II)
- Those with neurological disorders (e.g., multiple sclerosis, Parkinson's disease)
- Patients with morbid obesity (BMI greater than 40 Those who are)
- Those with abnormal bladder capacity (more than 300 cc large)
Show all 17Show fewer
- Those with abnormal post-void residuals (50 greater than cc)
- Urethral stricture and bladder neck contracture Those who are
- Spastic bladder
- Those with urinary tract infection (UTI)
- Those with vesicoureteral reflux
- Those with bladder stones
- Those with bladder tumors
- Difficulty understanding and adapting to work is mentally healthy to the extent that it can create patients without
- Fulfill the requirements of the work plan who may have trouble adapting to bring patients
- Negative, as determined by the researcher benefit/risk ratio
- Any research in the previous 30 days treatment (medication or device) has been received.
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
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, it is aimed to evaluate the effectiveness and safety of a newly developed, innovative medical device, as compared to TOT, in the patients diagnosed with urinary incontinence and requiring the surgical intervention.
Read the detailed description
The study is an open-label, prospective, parallel-group, randomized, controlled medical device clinical trial, conducted in two centers. The two arms of the trial consist of patients randomized to the new device group and to the TOT group. According to this distribution, one group will be subjected to the operation with the new device, and the other group will be subjected to the operation with a commercially available TOT. Primary objective: Evaluation of the effectiveness of using the new device in the surgical treatment of urinary incontinence. Secondary objectives: Evaluation of the effects of the new device use on patients' quality of life, treatment satisfaction, and sexual functions, as well as assessment of safety. The study includes evaluation of the progress employing objective (pad weight, number of incontinence episodes, urodynamic tests) and subjective tests (questionnaires, diaries) during the 12 months follow-up period.
- Conditions
- Urinary Incontinence
- Being tested
- TOT, VACS-D
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOTDevice
In the Transobturator Tape-TOT operation, the anterior vaginal wall is incised 2 cm sagittal 1.5 cm below the urethra in the dorsal lithotomy position and the paraurethral areas are separated by sharp and blunt dissection and the ischiopubic bone is reached with the finger. The skin is incised so as to remain 1 cm lateral to the ischiopubic ramus on the line passing through the clitoris, and the synthetic tape is placed from outside to inside with special inclined trocars, passing under the urethra close to the medial part of the obturator foramen. Cystoscopy is not performed during the procedure. The vagen mucosa is sutured and the procedure is terminated by inserting a urethral foley catheter. The urethral catheter is removed on postoperative day 1 after the investigator evaluates the patient.
VACS-DDevice
The VACS-Minifiks procedure is a vaginal application of a natural tissue repair procedure whose efficacy has been proven in the abdominal route. The second difference is that the procedure is performed through a single incision instead of the three incisions used in the Transobturator Tape-TOT operation. Thus, the same goal will be achieved in a less invasive way without placing an artificial permanent implant. There is no difference in parameters such as anesthesia, operation time, and discharge time.
| Study group | Role | What they receive |
|---|---|---|
| VACS-Minifiks (VACS-D) | Active comparator | During the surgical procedure, this group operated with VACS-Minifiks. Receives: Device: VACS-D |
| Transobturator Tape (TOT) | Active comparator | During the surgical procedure, this group operated with the commercially available Transobturator Tape (TOT). Receives: Device: 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: Baseline, 6 weeks, 3 months, 6 months, 12 months
Twenty-Four-Hour Pad Testing
This test is performed at home. Women are provided with a set of pads and advised not to modify their normal drinking or activities. The aim of such tests is to document leakage in a normal home environment. Pad loss greater than 4 g is designated as significant or a 'positive pad test'.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months
Number of Total Daily Incontinence Episodes
It was obtained using a three-day bladder diary. Objective. Meaningful for patients. Correlates with patients' daily activities. It may not be directly related to the severity of urine leakage. Subject to variability. Requires patient compliance. Day and night urine leakages were recorded separately by the patient for three days. The mean total score for a day was calculated.
Measured: 6 weeks, 3 months, 6 months, 12 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: Baseline, 6 weeks, 12 months
Urodynamic Assessment
The bladder is filled using the catheter and pressure measurements are continuously recorded and patient feedback regarding bladder sensation and urgency. Testing for stress incontinence is performed with coughing and straining. Leak Point Pressure and leakage episodes are recorded and analyzed to provide information regarding the type and severity of incontinence. At the end of the test, urine is passed to assess bladder function further and look for blockage of urinary flow.
Measured: Baseline, 12 months
Secondary outcomes (7)
Symptomatic Assessment for Overactivitive Bladder
Overactive Bladder Assessment Form (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: Baseline, 12 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: Baseline, 12 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. The patient's daily activities are taken into account. OAB-V8, UDI-6, and IIQ-7 are validated questionnaires and subjective. It was not correlated with the severity of urine leakage.
Measured: Baseline, 12 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: Baseline, 12 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: Baseline, 12 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: Baseline, 12 months
Assessment of Serious Adverse Events and Adverse Events
Patients will be evaluated for adverse events intraoperatively and at visits.
Measured: Intraoperative, postoperative 6 weeks, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start7 Jan 2022
- Primary completion5 Jul 2023
- Study completion6 Oct 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were randomized into two groups and underwent surgery.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soranus ArGe ve Danismanlik Hizmetleri Sanayi Ticaret A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cagdas Sahin, Assoc. Prof., Principal investigator, Ege University Faculty of Medicine Department of Obstetrics and GynecologyCenk Yasa, Professor, Principal investigator, Istanbul Faculty of Medicine, Department of Obstetrics and GynecologyOzgur Yeniel, Professor, Study director, Ege University Faculty of Medicine Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173180
- Sponsor's protocol ID
- VACS-D 001
- Acronym
- VACS-D
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. 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
- ClinicalTrials.gov ID
- NCT06173180
- Acronym / sponsor ID
- VACS-D / VACS-D 001
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Soranus ArGe ve Danismanlik Hizmetleri Sanayi Ticaret A.S.Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 15 Dec 2023 (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, it is aimed to evaluate the effectiveness and safety of a newly developed, innovative medical device, as compared to TOT, in the patients diagnosed with urinary incontinence and requiring the surgical intervention.
Detailed description
The study is an open-label, prospective, parallel-group, randomized, controlled medical device clinical trial, conducted in two centers. The two arms of the trial consist of patients randomized to the new device group and to the TOT group. According to this distribution, one group will be subjected to the operation with the new device, and the other group will be subjected to the operation with a commercially available TOT. Primary objective: Evaluation of the effectiveness of using the new device in the surgical treatment of urinary incontinence. Secondary objectives: Evaluation of the effects of the new device use on patients' quality of life, treatment satisfaction, and sexual functions, as well as assessment of safety. The study includes evaluation of the progress employing objective (pad weight, number of incontinence episodes, urodynamic tests) and subjective tests (questionnaires, diaries) during the 12 months follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants were randomized into two groups and underwent surgery.
| Arm | Type | Receives |
|---|---|---|
| VACS-Minifiks (VACS-D) | Active comparator | Device: VACS-DDuring the surgical procedure, this group operated with VACS-Minifiks. |
| Transobturator Tape (TOT) | Active comparator | Device: TOTDuring 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
Key inclusion criteria (8 listed)
- Those who have not received radiotherapy
- Women aged 40-65 years
- Accompanying infection according to urine culture results people who do not
- Informed about the study and participated in the study patients who have agreed to participate
- Acceptable contraception during work agree to continue to apply their methods those who
Key exclusion criteria (17 listed)
- Women who are pregnant, supported by biochemical laboratory findings
- Those in the urinary incontinence category other than SUI
- Those with significant pelvic organ prolapse (e.g., cystocele, rectocele); (as defined by the International Continence Society greater than phase II)
- Those with neurological disorders (e.g., multiple sclerosis, Parkinson's disease)
- Patients with morbid obesity (BMI greater than 40 Those who are)
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 |
|---|---|---|
| TOTIn the Transobturator Tape-TOT operation, the anterior vaginal wall is incised 2 cm sagittal 1.5 cm below the urethra in the dorsal lithotomy position and the paraurethral areas are separated by sharp and blunt dissection and the ischiopubic bone is reached with the finger. The skin is incised so as to remain 1 cm lateral to the ischiopubic ramus on the line passing through the clitoris, and the synthetic tape is placed from outside to inside with special inclined trocars, passing under the urethra close to the medial part of the obturator foramen. Cystoscopy is not performed during the procedure. The vagen mucosa is sutured and the procedure is terminated by inserting a urethral foley catheter. The urethral catheter is removed on postoperative day 1 after the investigator evaluates the patient. | Device | Transobturator Tape (TOT) |
| VACS-DThe VACS-Minifiks procedure is a vaginal application of a natural tissue repair procedure whose efficacy has been proven in the abdominal route. The second difference is that the procedure is performed through a single incision instead of the three incisions used in the Transobturator Tape-TOT operation. Thus, the same goal will be achieved in a less invasive way without placing an artificial permanent implant. There is no difference in parameters such as anesthesia, operation time, and discharge time. | Device | VACS-Minifiks (VACS-D) |
Primary outcome
One-Hour Pad Testing
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 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.
Twenty-Four-Hour Pad Testing
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months
This test is performed at home. Women are provided with a set of pads and advised not to modify their normal drinking or activities. The aim of such tests is to document leakage in a normal home environment. Pad loss greater than 4 g is designated as significant or a 'positive pad test'.
Number of Total Daily Incontinence Episodes
Time frame: 6 weeks, 3 months, 6 months, 12 months
It was obtained using a three-day bladder diary. Objective. Meaningful for patients. Correlates with patients' daily activities. It may not be directly related to the severity of urine leakage. Subject to variability. Requires patient compliance. Day and night urine leakages were recorded separately by the patient for three days. The mean total score for a day was calculated.
Evaluation of Quality of Life
Time frame: Baseline, 6 weeks, 12 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.
Urodynamic Assessment
Time frame: Baseline, 12 months
The bladder is filled using the catheter and pressure measurements are continuously recorded and patient feedback regarding bladder sensation and urgency. Testing for stress incontinence is performed with coughing and straining. Leak Point Pressure and leakage episodes are recorded and analyzed to provide information regarding the type and severity of incontinence. At the end of the test, urine is passed to assess bladder function further and look for blockage of urinary flow.
7 secondary outcomes
Symptomatic Assessment for Overactivitive Bladder
Time frame: Baseline, 12 months
Assess the Impact of the Dysfunction on Quality of Life
Time frame: Baseline, 12 months
Symptomatic Impact Assessment
Time frame: Baseline, 12 months
Assessment of Sexual Function
Time frame: Baseline, 12 months
Assessment of Sexual Function during Intercourse
Time frame: Baseline, 12 months
Post-Voiding Residual (PVR) Urine Volume
Time frame: Baseline, 12 months
Assessment of Serious Adverse Events and Adverse Events
Time frame: Intraoperative, postoperative 6 weeks, 3 months, 6 months, 12 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 15 Dec 2023.
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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.
Cagdas Sahin, Assoc. Prof. principal investigator
Ege University Faculty of Medicine Department of Obstetrics and Gynecology
Cenk Yasa, Professor principal investigator
Istanbul Faculty of Medicine, Department of Obstetrics and Gynecology
Ozgur Yeniel, Professor 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?
A study testing TOT and VACS-D in people with 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 8 inclusion and 17 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 15 Dec 2023. 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: Baseline, 6 weeks, 3 months, 6 months, 12 months). The study lists 5 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 15 Dec 2023.