Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03301818
Other study ID # 0300-17-RMB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT03625843 - Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing N/A
Not yet recruiting NCT06012370 - Injecting Plasma-rich Platelets & Hyaluronic Acid for Patients With Stress Urinary Incontinence N/A
Completed NCT03672461 - A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women N/A
Completed NCT03010800 - A Feasibility Device Study to Prevent Female Urinary Stress Incontinence N/A
Recruiting NCT06232525 - A Randomized Comparison of Transobturator Tape With the Plication of Urethral Ligaments in the Treatment of Stress Urinary Incontinence N/A
Recruiting NCT05768607 - Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension N/A
Recruiting NCT03397368 - Evaluation of Transperineal US in Stress Incontinence
Completed NCT05210738 - Single-incision Sling vs Urethral Bulking During Prolapse Surgery for Occult Stress Incontinence
Terminated NCT03847922 - Nitrous Oxide for Analgesia During Office Urethral Bulking Phase 4
Completed NCT03866356 - The Effectiveness of a Stress Incontinence Care Protocol N/A
Completed NCT03267719 - Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence N/A
Recruiting NCT05858125 - Social Media Navigation Aid Kits for Urinary Incontinence N/A