Vaginal Elasticity Assessment Before and After Surgical Repair for Urinary Stress Incontinence.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-07-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Female patients with USI will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after surgery for the repair of the USI. Surgical repair will be performed by a single surgeon who will perform a tension free vaginal tape obturator (TVT-O) repair.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vaginal Tactile Imaging for the Assessment of Pelvic Organ Prolapse Repair Efficiency

NCT03311685

Pelvic Organ Prolapse

COMPLETED NA

Vaginal Elasticity Assessment Before and After Vaginal Carbon Dioxide Laser Treatment.

NCT03630406

Laser Burn

COMPLETED

Void Trials After Two Voiding Trials (TVT)

NCT03937531

Postoperative Voiding Dysfunction Postoperative Urinary Retention

WITHDRAWN NA

Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI

NCT01392651

Urinary Stress Incontinence

COMPLETED

Anterior Vaginal Wall Repair With Mesh in Combination With TVT-O to Reduce Urinary Stress Incontinence

NCT01507714

Pelvic Organ Prolapse

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients will be recruited and sign a consent form. The patients included are patients with USI that are candidates for a TVT-O repair.

Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:

* The day of surgery before surgery.
* The day after surgery.
* 3 months post-operational. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Incontinence, Female

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients undergoing USI repair

Group Type EXPERIMENTAL

Vaginal tactile imager

Intervention Type DEVICE

Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after during a 3 month interval.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vaginal tactile imager

Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after during a 3 month interval.

Intervention Type DEVICE