Transobturator Subtrigonal Tape vs Transobturator Suburethral Tape for Stress Urinary Incontinence (S-TOTvsTOT)
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:
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.
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.
|Stress Urinary Incontinence||Procedure: transobturator subtrigonal tape S-TOT Procedure: Transobturator suburethral tape (TOT)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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|
- Stress urinary incontinence resolution, without postoperative obstruction [ Time Frame: six month ]
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
- Complications [ Time Frame: Two Years ]
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
|Study Start Date:||July 2016|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02112591
|Contact: Eduardo A Serrano-Brambila, MCs||52 55 email@example.com|
|Contact: Jorge Moreno-Palacios, MSc||52 55 firstname.lastname@example.org|
|IMSS Commission on Ethics in Research, Block B Bldg., Unidad de Congresos 4th Floor, Centro Médico Nacional Siglo XXI, Av. Cuauhtémoc 330, Colonia Doctores||Recruiting|
|Mexico City, Distrito Federal, Mexico, 06725|
|Contact: Eduardo A Serrano-Brambila, MSc 52 55 2128 9760 email@example.com|
|Contact: Jorge Moreno-Palacios, MSc 52 55 5457 2275 firstname.lastname@example.org|
|Principal Investigator: Eduardo A Serrano-Brambila, MSc|
|Principal Investigator:||Eduardo A. Serrano-Brambila, MSc||Instituto Mexicano del Seguro Social|