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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martin Rudnicki, Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT01754558
First received: December 28, 2011
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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

Condition Intervention
Urinary Stress Incontinence
Procedure: Ajust system
Procedure: TVT/TVT-O

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Roskilde County Hospital:

Primary Outcome Measures:
  • A change in number of cured patients [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • Pain-perception following surgery [ Time Frame: Evaluated the first week following surgery, and at three and 12 months follow-up ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 500
Study Start Date: May 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ajust sling
The sling a a new device for stress urinary incontinence. The sling is ajustable and is not penetrating the skin, i.e. is only attached to the obturator membrane
Procedure: Ajust system
The use of Ajust system for stress incontinence
Procedure: TVT/TVT-O
sling surgery
Experimental: TVT/TVT-O, polypropylne slings
TVT/TVT-O system. These two systems is wellknown and used for treatment of stress urinary incontinence. The sling penetrate the skin in order to secure adjustment.
Procedure: Ajust system
The use of Ajust system for stress incontinence
Procedure: TVT/TVT-O
sling surgery

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

3. 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:

  1. Previous anti-incontinence surgery.
  2. Residual urine volume >100 ml
  3. Bladder capacity <200ml according to diary.
  4. Planned or current pregnancy
  5. Repeated urinary tract infections (>4 cystitis last year )
  6. Current anticoagulation therapy that can´t be interrupted in due time prior to surgery
  7. Known abnormal coagulation
  8. Allergy to local anaesthetics
  9. Co-existing pelvic pathology, such as ovarian mass etc
  10. Vaginal POPQ anterior prolapse grade >=2
  11. A medical history of predominantly urge urinary incontinence.
  12. Patients unable to understand the protocol and a follow up
  13. Patients younger than 18 and above or equal to 60 years.
  14. Known or suspected neurological condition
  15. Patients who have not paused acethylsalicylic acid (ASA) medication 7 days prior to surgery
  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: NCT01754558

Locations
Denmark
Martin Rudnicki
Roskilde, Denmark, 4000
Sponsors and Collaborators
Roskilde County Hospital
  More Information

No publications provided

Responsible Party: Martin Rudnicki, Ass. Professor, Roskilde County Hospital
ClinicalTrials.gov Identifier: NCT01754558     History of Changes
Other Study ID Numbers: SJ-252
Study First Received: December 28, 2011
Last Updated: May 1, 2014
Health Authority: Denmark: The Danish National Scientific Board

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

ClinicalTrials.gov processed this record on July 22, 2014