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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam health care campus

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Any woman undergoing USI repair.

Exclusion criteria

Women with high grade pelvic floor prolapse.

Treatment and study plan

Vaginal tactile imager

Device

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

Primary outcomes

Vaginal elasticity assessment

Time frame: up to 3 months from enrollment

Vaginal elasticity as measured by the vaginal tactile imager

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Vaginal Elasticity Assessment Before and After the Affect of Surgical Repair for Urinary Stress Incontinence (USI) on Vaginal Elasticity as Measured by Vaginal Tactile Imaging.

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Oct 4, 2017
Registry last updated: Jul 27, 2020

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.

Published trials that share one or more normalized conditions with this study.

Completed