NCT03311685

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

Vaginal Elasticity Assessment Before and After the Affect of Surgical Repair for Pelvic Organ Prolapse (POP) on Vaginal Elasticity as Measured by Vaginal Tactile Imaging

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
DEVICE	vaginal tactile imager	Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after surgery in a 3 month interval.

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-06-30
• Completion: 2020-07-20
• First posted: 2017-10-17
• Last updated: 2020-07-27

Locations

1 site across 1 country: Israel