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New device aims to fix leaky bladder in women

NCT ID NCT07483138

Disease control Sponsor: Soranus ArGe ve Danismanlik Hizmetleri Sanayi Ticaret A.S. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a vaginal suture knotting device (VACS-MINIFIKS) in 36 women with stress urinary incontinence. The goal was to see if the device could reduce urine leakage and improve quality of life over 24 months. Participants had pad tests and questionnaires to measure success.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vaginal suture knotting device (VACS-MINIFIKS)
What this could lead to
If successful, this device could offer a surgical option for women with stress urinary incontinence, potentially improving quality of life.
What could go wrong
This is a small, completed follow-up study with only 36 participants. Results may not apply to all women, and long-term risks or device failures are not fully known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

36 people

The number who actually took part.

Started

Feb 2025

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

40 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

female stress incontinence Urinary Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urinary incontinence

Contacts and locations

Locations

  • Department of Gynecology and Obstetrics, Department of Surgical Medical Sciences, Istanbul Faculty of Medicine

    Istanbul, 34093, Turkey (Türkiye)

  • Ege University Faculty of Medicine, Department of Obstetrics and Gynecology

    Izmir, 35100, Turkey (Türkiye)

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