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Completed

NCT Number: NCT07483138

VACS Device Clinical Study for Incontinence Treatment: 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.

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Key information

Conditions

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

Age range

40 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Gynecology and Obstetrics, Department of Surgical Medical Sciences, Istanbul Faculty of Medicine, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Symptomatic Assessment for Overactive Bladder

    Time frame: after 24 months

    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.

  2. Assess the Impact of the Dysfunction on Quality of Life

    Time frame: after 24 months

    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.

  3. Symptomatic Impact Assessment

    Time frame: after 24 months

    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.

  4. Assessment of Sexual Function

    Time frame: after 24 months

    It was used for impact on sexual function using the Female Sexual Function Inventory (FSFI), a validated, gender-specific measure of sexual function.

  5. Assessment of Sexual Function during Intercourse

    Time frame: after 24 months

    Coital Incontinence Questionnaire (CIQ) is a validated, gender-specific measure of sexual function. It was used for the impact on sexual function during Intercourse.

  6. Post-Voiding Residual (PVR) Urine Volume

    Time frame: after 24 months

    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.

Sponsors and collaborators

Lead sponsor

Soranus ArGe ve Danismanlik Hizmetleri Sanayi Ticaret A.S.

Industry

Registry information

Official study title

Clinical Evaluation of Vaginal Suture Knotting Device in the Treatment of Urinary Incontinence in Women: Long-term Follow-up Study

Acronym: VACS-D: FuS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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