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

NCT01754558 | Completed

• 1 other identifier: SJ-252
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Urinary Stress Incontinence

Outcome Measures

Primary Outcomes (1)

• A change in number of cured patients

  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.

  Up to 1 year

Secondary Outcomes (1)

• Pain-perception following surgery

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

Other Outcomes (1)

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

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

Study Arms (2)

Ajust sling

EXPERIMENTAL

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; Procedure: TVT/TVT-O

TVT/TVT-O, polypropylne slings

EXPERIMENTAL

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; Procedure: TVT/TVT-O

Interventions

Ajust system PROCEDURE

The use of Ajust system for stress incontinence

Ajust sling; TVT/TVT-O, polypropylne slings

TVT/TVT-O PROCEDURE

sling surgery

Ajust sling; TVT/TVT-O, polypropylne slings

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.?

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Martin Rudnicki

Roskilde, Roskilde, 4000, Denmark

Location

Related Publications (2)

• Temtanakitpaisan T, Buppasiri P, Lumbiganon P, Laopaiboon M, Rattanakanokchai S. Prophylactic antibiotics for preventing infection after continence surgery in women with stress urinary incontinence. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD012457. doi: 10.1002/14651858.CD012457.pub2.

  PMID: 35349162 DERIVED

• Rudnicki M, von Bothmer-Ostling K, Holstad A, Magnusson C, Majida M, Merkel C, Prien J, Jakobsson U, Teleman P. Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence. A randomized controlled trial. Acta Obstet Gynecol Scand. 2017 Nov;96(11):1347-1356. doi: 10.1111/aogs.13205. Epub 2017 Sep 15.

  PMID: 28815547 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Professor

Study Record Dates

• First Submitted: December 28, 2011
• First Posted: December 21, 2012
• Study Start: May 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 2, 2014

Record last verified: 2014-05

Locations

DK (1)