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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | after 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Cenk Yasa, Professor | Istanbul Faculty of Medicine, Department of Obstetrics and Gynecology | Principal Investigator |
| Gokay Ozceltik | Ege University Faculty of Medicine Department of Obstetrics and Gynecology | Principal Investigator |
| Ozgur Yeniel | Ege University Faculty of Medicine Department of Obstetrics and Gynecology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecology and Obstetrics, Department of Surgical Medical Sciences, Istanbul Faculty of Medicine | Istanbul | 34093 | Turkey (Türkiye) |
Data available from the corresponding author upon reasonable request.
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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. |
| 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. | 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. | 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. | 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. | after 24 months |
| Ege University Faculty of Medicine, Department of Obstetrics and Gynecology | Izmir | 35100 | Turkey (Türkiye) |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |