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

Stress Incontinence, Female Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301818
• Other study ID #: 0300-17-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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• 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 USI repair.

Exclusion Criteria:

• Women with high grade pelvic floor prolapse.

Related Conditions & MeSH terms

• Stress Incontinence, Female
• Urinary Incontinence, Stress

Intervention

Device:
• Vaginal tactile imager
Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after during 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	up to 3 months from enrollment