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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311685
• Other study ID #: 0295-17-RMB
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: July 20, 2020

Study information

• Verified date: July 2020
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 20, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Any woman undergoing POP repair

Exclusion Criteria:

• Women above or below the age limit

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal elasticity assessment	Vaginal elasticity as measured by the vaginal tactile imager measuring the local vaginal pressure (in mmHg)	Up to 3 months from enrollment
Secondary	Comparison of vaginal elasticity between repair methods	Assessment of the difference in vaginal elasticity (measured in mmHg) between the laparoscopic and vaginal surgical repair groups.	Up to 3 months from enrollment