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

Not Applicable

Completed

• Conditions: Stress Incontinence, Female
• Interventions: Device: Vaginal tactile imager

• Registration Number: NCT03301818
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-09-29
• Study First Posted: 2017-10-04
• Study Start: 2018-08-01
• Primary Completion: 2020-06-30
• Status Verified: 2020-07
• Study Completion: 2020-07-20
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

• Any woman undergoing USI repair.

Exclusion Criteria

• Women with high grade pelvic floor prolapse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing USI repair	Vaginal tactile imager	-

Primary Outcome Measures

Name	Time	Method
Vaginal elasticity assessment	up to 3 months from enrollment	Vaginal elasticity as measured by the vaginal tactile imager

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel