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

Rambam Health Care Campus

Status: Completed

Conditions: Stress Incontinence, Female

Treatments: Device: Vaginal tactile imager

Study type: Interventional

Funder types: Other

Identifiers

NCT03301818

0300-17-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any woman undergoing USI repair.

Exclusion criteria

• Women with high grade pelvic floor prolapse.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Patients undergoing USI repair

Experimental group

Treatment:

Device: Vaginal tactile imager