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

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Device: vaginal tactile imager

• Registration Number: NCT03311685
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Study Timeline

• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-17
• 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: 30

Inclusion Criteria

• Any woman undergoing POP repair

Exclusion Criteria

• Women above or below the age limit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal POP repair	vaginal tactile imager	Patients undergoing vaginal surgery for the repair of pelvic organ prolapse. vaginal tactile imager
Laparoscopic POP repair	vaginal tactile imager	Patients undergoing laparoscopic surgery for the repair of pelvic organ prolapse. 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 measuring the local vaginal pressure (in mmHg)

Secondary Outcome Measures

Name	Time	Method
Comparison of vaginal elasticity between repair methods	Up to 3 months from enrollment	Assessment of the difference in vaginal elasticity (measured in mmHg) between the laparoscopic and vaginal surgical repair groups.

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel