Transobturator Subtrigonal Tape vs Transobturator Suburethral Tape for Stress Urinary Incontinence (S-TOTvsTOT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Coordinación de Investigación en Salud, Mexico
Sponsor:
Collaborators:
Juan Talavera Piña
Hector Eduardo Meza Vazquez
Jorge Moreno Palacios
Efrain Maldonado Alcaraz
Jose Fugarolas Marin
Edna Cortes Fuentes
Information provided by (Responsible Party):
Eduardo Serrano Brambila, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT02112591
First received: April 9, 2014
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Stress Urinary Incontinence
Procedure: transobturator subtrigonal tape S-TOT
Procedure: Transobturator suburethral tape (TOT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Transobturator Subtrigonal Tape vs Transobturator Tension-free Suburethral Tape for the Correction of Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • Stress urinary incontinence resolution, without postoperative obstruction [ Time Frame: six month ] [ Designated as safety issue: Yes ]

    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



Secondary Outcome Measures:
  • Complications [ Time Frame: Two Years ] [ Designated as safety issue: Yes ]

    Presence of:

    Recurrent Urinary Infection: Symptoms, irregular general urine test and urine culture with bacterial growth >1 occurrence per year after the procedure Groin pain (visual analog scale) >3 months after the procedure (none, mild, moderate and severe) Extrusion of the tape: Exposure of the mesh outside the body (by observation) Intrusion of the tape: Migration of the mesh inside the urinary or digestive system (by open or endoscopic observation) Infection of the mesh and/or wound: Presence of erythema, exudate and local swelling of the wound or tissues surrounding the mesh, by direct observation with or without microbiological testBladder perforation: Intraoperative bladder opening caused by needles or any other instrument Significant bleeding: Hemorrhage and/or intraoperative or postoperative hematoma >1000ml



Estimated Enrollment: 68
Study Start Date: June 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transobturator suburethral tape (TOT)
transobturator approaches for the placement in mid-urethral position of polypropylene tape that is 1.5cm wide
Procedure: Transobturator suburethral tape (TOT)
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
Other Name: Trans-Obturator Tape
Experimental: S-TOT
transobturator subtrigonal tape: S-TOT
Procedure: transobturator subtrigonal tape S-TOT
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.
Other Name: S-TOT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • History of previous anti-incontinence surgery
  • Intrinsic sphincter deficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112591

Contacts
Contact: Eduardo A Serrano-Brambila, MCs 52 55 21289760 eserranob@hotmail.com
Contact: Jorge Moreno-Palacios, MSc 52 55 54572275 jorgemorenomd@hotmail.com

Locations
Mexico
IMSS Commission on Ethics in Research, Block B Bldg., Unidad de Congresos 4th Floor, Centro Médico Nacional Siglo XXI, Av. Cuauhtémoc 330, Colonia Doctores Not yet recruiting
Mexico City, Distrito Federal, Mexico, 06725
Contact: Eduardo A Serrano-Brambila, MSc    52 55 2128 9760    eserranob@hotmail.com   
Contact: Jorge Moreno-Palacios, MSc    52 55 5457 2275    jorgemorenomd@hotmail.com   
Principal Investigator: Eduardo A Serrano-Brambila, MSc         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Juan Talavera Piña
Hector Eduardo Meza Vazquez
Jorge Moreno Palacios
Efrain Maldonado Alcaraz
Jose Fugarolas Marin
Edna Cortes Fuentes
Investigators
Principal Investigator: Eduardo A. Serrano-Brambila, MSc Instituto Mexicano del Seguro Social
  More Information

No publications provided

Responsible Party: Eduardo Serrano Brambila, Master in Science, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT02112591     History of Changes
Other Study ID Numbers: F-CNIC-2012-160
Study First Received: April 9, 2014
Last Updated: April 11, 2014
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Coordinación de Investigación en Salud, Mexico:
Stress urinary incontinence
mesh
tape
micturition dysfunction
urinary obstruction
TOT

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

ClinicalTrials.gov processed this record on August 27, 2014