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Completed

NCT Number: NCT01754558

One Year Outcome Using the Ajust System for Treatment of Urinary Stress Incontinence

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

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Martin Rudnicki

Roskilde, 4000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. A medical history of stress urinary incontinence, i.e. leakage during coughing, sneezing or leakage during physical exertion. OR 2. A medical history of mixed urinary stress incontinence defined as complaint of involuntary leakage associated with urgency and stress incontinence. Stress incontinence has to the dominating symptom defined as more episodes of leakage due to coughing or physical exertion than with urgency.
  • A provocative stress test up to ten coughs at a standardized bladder volume (300 ml) confirming urinary leakage from the urethra while the patient is asked to cough or perform a Valsalva manoeuvre standing or lying (7). Furthermore, the patient has to present hypermobility of the urethra/bladder neck defined as significant downward rotation when coughing or during Valsalva.?

Exclusion criteria

  • Previous anti-incontinence surgery.
  • Residual urine volume >100 ml
  • Bladder capacity <200ml according to diary.
  • Planned or current pregnancy
  • Repeated urinary tract infections (>4 cystitis last year )
  • Current anticoagulation therapy that can´t be interrupted in due time prior to surgery
  • Known abnormal coagulation
  • Allergy to local anaesthetics
  • Co-existing pelvic pathology, such as ovarian mass etc
  • Vaginal POPQ anterior prolapse grade >=2
  • A medical history of predominantly urge urinary incontinence.
  • Patients unable to understand the protocol and a follow up
  • Patients younger than 18 and above or equal to 60 years.
  • Known or suspected neurological condition
  • Patients who have not paused acethylsalicylic acid (ASA) medication 7 days prior to surgery

Treatment and study plan

Ajust system

Procedure

The use of Ajust system for stress incontinence

TVT/TVT-O

Procedure

sling surgery

Primary outcomes

  1. A change in number of cured patients

    Time frame: Up to 1 year

    Primary endpoint: A change in number of cured patients. The number of patients cured is anticipated to be equal in each group.

    A cured patients is defined as having no subjective symptoms (i.e. no scores on the ICIQ-UI SF and ICIQ-OAB) and no objective detectable urinary leakage during coughing (300cc in the bladder and no leakage during coughing.

Secondary outcomes

  1. Pain-perception following surgery

    Time frame: Evaluated the first week following surgery, and at three and 12 months follow-up

    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

Other outcomes

  1. number of urinary tract infections and infections related to the vaginal closure during the first postoperative months.

    Time frame: Evaluated during the first week of follow-up and at 3 months follow-up

    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

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2012
Registry last updated
May 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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