Transobturator Subtrigonal Tape vs Transobturator Suburethral Tape for Stress Urinary Incontinence

NCT02112591 | Unknown

• 1 other identifier: F-CNIC-2012-160
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Minimally invasive procedures TOT (tension-free suburethral tape using transobturator approach)have been the standard for correction of SUI. However, around 28% of these patients exhibit alteration of urinary flow. Recently, in 40 patients who underwent open surgery, an abdominal fascia tape was placed in a subtrigonal position with a success rate of 87.5% without obstruction. Our intention is to make the most of the idea of subtrigonal position in minimally invasive procedures with transobturator polypropylene vaginal tape (S-TOT). Object of the Study: To evaluate the efficacy and security of S-TOT compared with TOT. Materials and Methods: Study Population: Patients of the Mexican Institute of Social Security (IMSS) with an SUI diagnosis. Eligibility requirements: history of at least 3 months with symptoms of isolated SUI or symptoms of SUI associated with urge urinary incontinence (mixed UI). The size of the sample was estimated 34 subjects are required per group. Study Design: It is a parallel group randomized clinical trial. Success (efficacy) will be defined as when the SUI has been corrected with negative pad test and normal urinary flow. The results (efficacy) will be compared between the two groups using chi2 (group a/b versus success/lack of success). In all cases, p \<0.05 will be considered significant. The data will be obtained with clinical evaluation, laboratory and radiological/imaging tests and the respective questionnaires during the visits before surgery, and at 2 and 6 weeks, and 6, 12, and 24 months after surgery.

Conditions

Stress Urinary Incontinence

Keywords

Stress urinary incontinence; mesh; tape; micturition dysfunction; urinary obstruction; TOT

Outcome Measures

Primary Outcomes (1)

• Stress urinary incontinence resolution, without postoperative obstruction

  Resolution of SUI: Negative 1/h pad test and regular urination (without change or obstruction in the Blaivas Nomogram and/or the Female Urinary Symptom Score). Negative pad test, \<3g/1 hours. -Postoperative Obstruction: Female Urinary Symptom Score (FUSS): 1-7 points = mild obstruction, 8-18 = moderate obstruction, and \>19 = severe obstruction AND/ OR Ascending change in the level of obstruction provided that there is an increase of ≥ 5 points compared to the baseline AND/ OR Qmax: ≤20ml/s, provided there is a reduction compared to the baseline AND/ OR Blaivas Nomogram: The intersection of Qmax (abscissa) and maximum contraction of the detrusor (ordinate) will fall in one of four possible areas: not obstructed, mild obstruction, moderate obstruction or severe obstruction

  six month

Secondary Outcomes (1)

• Complications

  Two Years

Study Arms (2)

Transobturator suburethral tape (TOT)

ACTIVE COMPARATOR

transobturator approaches for the placement in mid-urethral position of polypropylene tape that is 1.5cm wide

Procedure: Transobturator suburethral tape (TOT)

S-TOT

EXPERIMENTAL

transobturator subtrigonal tape: S-TOT

Procedure: transobturator subtrigonal tape S-TOT

Interventions

transobturator subtrigonal tape S-TOT PROCEDURE

Minimally invasive surgery for placement of suburethral polypropylene tape (TOT), which is widely used around the world and considered the standard of treatment at present, has very limited efficacy when considering the correction of SUI without affecting normal micturition. There is evidence that the placement of autologous fascia tape in subtrigonal position has higher efficacy. Thus, the subtrigonal placement of polypropylene mesh tape through minimally invasive procedures could have higher efficacy.

Also known as: S-TOT

S-TOT

Transobturator suburethral tape (TOT) PROCEDURE

Minimally invasive procedures in which needles are inserted via transobturator approach for the placement in mid-urethral position of polypropylene tape that is 1.5cm wide for the treatment of SUI

Also known as: Trans-Obturator Tape

Transobturator suburethral tape (TOT)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-report of SUI symptoms lasting at least 3 months as shown on ICIQ-SF questionnaire
• Observation of urinary leakage following a cough and stress test with a cough and/or Valsalva maneuver, with bladder volume \<300ml.
• Bladder capacity \>200ml
• Post-void residual bladder volume \<100ml

You may not qualify if:

• Inability to walk (allowed with walking aids)
• Positive pregnancy test
• Prolapse of pelvic organs beyond the vaginal vestibule during stress
• Current chemotherapy or history of pelvic radiotherapy
• Systemic disease affecting bladder function (i.e., Parkinson's disease, multiple sclerosis, bifid spinal, spinal cord injury or any trauma)
• Urethral diverticulum, current or previous
• History of augmentation cystoplasty or artificial sphincter
• Nerve stimulator implant for urinary symptoms
• History of synthetic vaginal sling for SUI or vaginal reconstruction
• Less than 12 months since giving birth
• Pelvic surgery, open or laparoscopic, \<3 months ago
• Current evaluation or treatment for chronic pelvic pain
• Participation in other intervention study for treatment that may interfere with the results of this study
• Need for concomitant surgery that requires an open or laparoscopic abdominal incision
• The use of synthetic material or the use of biological material in the anterior compartment

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

IMSS Commission on Ethics in Research, Block B Bldg., Unidad de Congresos 4th Floor, Centro Médico Nacional Siglo XXI, Av. Cuauhtémoc 330, Colonia Doctores

Mexico City, Mexico City, 06725, Mexico

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Eduardo A. Serrano-Brambila, MSc

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo A Serrano-Brambila, MCs

CONTACT

52 55 21289760; eserranob@hotmail.com

Jorge Moreno-Palacios, MSc

CONTACT

52 55 54572275; jorgemorenomd@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in Science

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 14, 2014
• Study Start: July 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

ME (1)