Clinical Trials Logo

Clinical Trial Summary

During the last decade numerous new procedures have been presented regarding surgical treatment of urinary stress incontinence (1,2). Development of the midurethral tape procedure (TVT) changed the surgical procedure dramatically both regarding the extent of the surgical procedure and also decreased the morbidity remarkably. The success rate of the TVT procedure has been proven to be high (1,2 ). However, the development of the TOT/TVT-O procedures disclosed a new fixation point and further decreased the risk of bladder injury (1,2). Since the introduction of trans-obturator slings several mini-slings have been introduced in order to reduce the need of perforation of the skin and muscles (3,4,5). Although some systems seem promising (5) others have disclosed a long learning curve, pain problems following the procedure and lower success rates, compared to the traditional sling procedures. None of these mini-slings have been adjustable.

Recently the Ajust system for treatment of stress urinary incontinence was introduced. The system is a single incision sling procedure and consists of an adjustable Polypropylene mesh sling with self fixation anchors (6). In a feasibility study (6), the 6 months objective cure rate was 82%, but there is a lack of information regarding adverse events and durability of treatment success. Our preliminary experiences suggest, that the procedure has a rapid learning curve, low pain scores postoperatively and a 94% cure rate at 3 months follow-up (personal observation). Recently, several abstracts have indicated that the cure rate obtained by Ajust is comparable to TVT or TVT-O (10-12).

The purpose of the present study is (primary outcome):

To test the hypothesis that the Ajust and TVT, TVT-O and TOT, respectively are equal regarding subjective cure rate (cure is defined as subjectively not incontinent at all), i.e. the study is designed as a non-inferiority study. The study is performed as a randomised controlled trial without blinding. The study is powered to detect a 9% difference between the two groups. The subjective cure rate is based on ICIQ measurement

Secondary outcome:

- To test the hypothesis that Ajust is associated with a significantly lower postoperative pain perception.

- To test the hypothesis that antibiotic treatment is not necessary


Clinical Trial Description

Primary endpoint: A cured patients is defined as no subjective symptoms (ICIQ-UI SF and ICIQ-OAB) and no objective detectable urinary leakage during coughing (300cc in the bladder and no leakage during coughing)

Secondary outcome: Pain-perception is evaluated by VAS scoring daily during the first postoperative week, including assessing the need for painkilling medication

The endpoint regarding the use of antibiotics is based on the number of urinary tract infections and infections related to the vaginal closure during the first postoperative months. All patients will evaluated postoperative by physical examination and by urinary dipstick ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01754558
Study type Interventional
Source Roskilde County Hospital
Contact
Status Completed
Phase N/A
Start date May 2012
Completion date April 2014

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02867748 - 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 N/A
Recruiting NCT02617797 - Radiofrequency in the Female Stress Urinary Incontinence N/A
Active, not recruiting NCT02538991 - TVT Versus Bulkamid®-Injections in Treatment of Stress Urinary Incontinence N/A
Completed NCT02480231 - Mid-Urethral Sling Tensioning Trial N/A
Terminated NCT02591381 - Transcorporal Versus Standard Artificial Urinary Sphincter Placement N/A
Completed NCT00984958 - Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure N/A
Completed NCT00190567 - Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence Phase 2
Completed NCT02423486 - The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback N/A
Recruiting NCT00136071 - Transvaginal Tension Free Vaginal Tape-Obturator (TVT-O) Versus Transobturator Tape-Mentor (TOT) in the Management of Urodynamic Stress Urinary Incontinence N/A
Completed NCT00190619 - Efficacy and Safety of Duloxetine Phase 3
Completed NCT04288648 - Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence
Active, not recruiting NCT05182632 - Tele-rehabilitation Group Program for Urinary Incontinence in Older Women N/A
Completed NCT03672461 - A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women N/A
Completed NCT02407145 - Safety and Efficacy of PVDF (DynaMesh®-SIS Soft) Retropubic Midurethral Slings in Stress Urinary Incontinence in Women
Completed NCT01784172 - Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial Phase 2
Not yet recruiting NCT06469320 - Urinary Incontinence and Other Pelvic Floor Dysfunctions in Trail Runners
Recruiting NCT02935803 - A Study on the Anti-incontinent Effectiveness of the mTVM Method in POPQ Stage II-III Patients N/A
Active, not recruiting NCT02039830 - Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women N/A
Recruiting NCT04817839 - Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures N/A
Completed NCT03439527 - Multisystem Cell Therapy for Improvement of Urinary Continence Phase 1