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

Rambam Health Care Campus

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Device: vaginal tactile imager

Study type: Interventional

Funder types: Other

Identifiers

NCT03311685

0295-17-RMB

Details and patient eligibility

About

Female patients with POP will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after surgery for the repair of the POP. Surgical repair will be performed by a single surgeon who will perform either a laparoscopic or vaginal repair.

Full description

Patients will be recruited and sign a consent form. The patients included are patients with POP that are candidates for either laparoscopic or vaginal 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: 30 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any woman undergoing POP repair

Exclusion criteria

• Women above or below the age limit

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Laparoscopic POP repair

Experimental group

Description:

Patients undergoing laparoscopic surgery for the repair of pelvic organ prolapse. vaginal tactile imager

Treatment:

Device: vaginal tactile imager

Vaginal POP repair

Experimental group

Description:

Patients undergoing vaginal surgery for the repair of pelvic organ prolapse. vaginal tactile imager

Treatment:

Device: vaginal tactile imager