Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03311685
Enrollment
30
Registered
2017-10-17
Start date
2018-08-01
Completion date
2020-07-20
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

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.

Interventions

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

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Any woman undergoing POP repair

Exclusion criteria

* Women above or below the age limit

Design outcomes

Primary

MeasureTime frameDescription
Vaginal elasticity assessmentUp to 3 months from enrollmentVaginal elasticity as measured by the vaginal tactile imager measuring the local vaginal pressure (in mmHg)

Secondary

MeasureTime frameDescription
Comparison of vaginal elasticity between repair methodsUp to 3 months from enrollmentAssessment of the difference in vaginal elasticity (measured in mmHg) between the laparoscopic and vaginal surgical repair groups.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026