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TVT-ABBREVO Versus SERASIS for the Treatment of Female Urinary Stress Incontinence: 1 Year Outcomes of a Comparative Study With 2 Trans-obturator Sub Mid Urethral Slings

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ClinicalTrials.gov Identifier: NCT02867748
Recruitment Status : Active, not recruiting
First Posted : August 16, 2016
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Western Galilee Hospital-Nahariya

Brief Summary:

Abstract:

Urinary Stress Incontinence (USI)- is a discomforting condition that negatively affects the quality of life of many female individuals and frequently treated by surgical intervention. The incontinence curative operations revolutionized at 1995, with the introduction of the first retro-pubic sub-mid urethral synthetic sling, firstly named Intra-Vaginal Sling-plasty (IVS) and then Tension Free Vaginal Tape (TVT), by Ulmsten and Petros. This was later proposed to be done trans-obturatorly (TOT), for avoiding operative bladder injuries.

Among other peri-operative complications attributed to the commonly used anti-incontinence TOT are the thigh and groin pain. These pains are subjects of concern for patients and physicians worldwide. Another, rare yet very disturbing post-operative complication is erosion of the polypropylene tape into the vagina. TOT palpation at vaginal examination was claimed to be a predictive sign for future erosion of the polypropylene tape into the vaginal cavity.

This current study aims to compare TVT-Abbrevo procedure (12 cm polypropylene tape, Ethicon J&J Somerville, NJ, USA ) to Serasis procedure (softly knitted monofilament non-absorbable polypropylene, Serag-Wiessner, Naila, Germany) for the cure of USI. The purpose of this study is to evaluate the feasibility, the safety and the cure rate of both procedures, as well as documenting the post-operative immediate, and long term thigh and groin pain levels, and dyspareunia. This study is aimed to evaluate the palpability of the implanted tapes at vaginal examination and the possible relation of this to further vaginal tape exposure.

Investigators hypothesized that using Serasis tape, which is made of a softer polypropylene material than rather rigid TVT-Abbrevo polypropylene tape might result in lower pain levels at the short and long term post-operative course, as well as to reduced tape palpability and exposure to the vaginal cavity. investigators believe that favorable results for this study might improve patients' post-operative quality of life and overall satisfaction.

Keywords: Serasis, TVT-Abbrevo, USI, pain, groin, thigh, dyspareunia, safety, urinary stress incontinence, sub mid urethral sling, trans-obturator, TOT, Intra-Vaginal-Sling plasty.


Condition or disease Intervention/treatment Phase
Urinary Stress Incontinence Procedure: TVT-Abbrevo Procedure: Serasis Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2016
Actual Primary Completion Date : September 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
TVT-Abbrevo
Procedure: TVT-Abbrevo
Experimental: 2
Serasis
Procedure: Serasis



Primary Outcome Measures :
  1. urinary stress incontinence cure [ Time Frame: one year follow up ]

    Primary outcome measure will be the cure of urinary stress incontinence subjective as reported by the patient in percentage of postoperative residual leak vs preoperative leak.

    Objective cure rate will be the leakage at physical examination cough test with full bladder (200-400ml) verified by US



Secondary Outcome Measures :
  1. Safety, intra and postoperative adverse effects [ Time Frame: 1 year follow up ]
    the ability to palpate the sling at vaginal examination (yes/no)



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women suffering from urinary incontinence during physical exertion proved by clinical examination

Exclusion Criteria:

  1. Women younger than 30 and older than 80 years old.
  2. Women who had surgical procedures involving the pelvic floor, either for the treatment of USI or for Pelvic Organ Prolapse (POP).
  3. Women who suffer from advanced POP (POP-Quantification system (POP-Q) stage more than 2).
  4. Patients who have absent or incomplete medical records.
  5. Women who refuse to participate with the study.
  6. Women who are not able to give informed consent or participate with this randomized research study for any other reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867748


Locations
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Israel
Western Galilee MC
Nahariya, Israel, 65432
Assuta MC
Tel Aviv, Israel, 45320
Sponsors and Collaborators
Western Galilee Hospital-Nahariya

Publications of Results:
Other Publications:

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Responsible Party: Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT02867748     History of Changes
Other Study ID Numbers: 0141-15-NHR
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: November 2017

Keywords provided by Western Galilee Hospital-Nahariya:
tvt abbrevo , Serasis

Additional relevant MeSH terms:
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Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms