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Vaginal Elasticity Assessment Before and After Surgical Repair for Urinary Stress Incontinence.

Vaginal Elasticity Assessment Before and After the Affect of Surgical Repair for Urinary Stress Incontinence (USI) on Vaginal Elasticity as Measured by Vaginal Tactile Imaging.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03301818
Enrollment
23
Registered
2017-10-04
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

Stress Incontinence, Female

Brief summary

Female patients with USI will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after surgery for the repair of the USI. Surgical repair will be performed by a single surgeon who will perform a tension free vaginal tape obturator (TVT-O) repair.

Detailed description

Patients will be recruited and sign a consent form. The patients included are patients with USI that are candidates for a TVT-O 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 during a 3 month interval.

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

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

Inclusion criteria

* Any woman undergoing USI repair.

Exclusion criteria

* Women with high grade pelvic floor prolapse.

Design outcomes

Primary

MeasureTime frameDescription
Vaginal elasticity assessmentup to 3 months from enrollmentVaginal elasticity as measured by the vaginal tactile imager

Countries

Israel

Outcome results

None listed

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