Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
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


Options:
A: Arm Label: Cranberry Extract Capsules; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Cranberry extract capsules | Arm Label: Placebo Capsules; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo capsule | Intervention Type: DIETARY_SUPPLEMENT; Name: Cranberry extract capsules; Assigned to Arm(s): Cranberry Extract Capsules | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo capsule; Assigned to Arm(s): Placebo Capsules
B: Arm Label: Treatment; Type: EXPERIMENTAL; Interventions: Drug: Nitrofurantoin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Nitrofurantoin; Assigned to Arm(s): Treatment | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: BMI <30; Type: N/A; Interventions: N/A | Arm Label: BMI 30-39; Type: N/A; Interventions: N/A | Arm Label: BMI >40; Type: N/A; Interventions: N/A
D: Arm Label: Ajust sling; Type: EXPERIMENTAL; Interventions: Procedure: Ajust system, Procedure: TVT/TVT-O | Arm Label: TVT/TVT-O, polypropylne slings; Type: EXPERIMENTAL; Interventions: Procedure: Ajust system, Procedure: TVT/TVT-O | Intervention Type: PROCEDURE; Name: Ajust system; Assigned to Arm(s): Ajust sling, TVT/TVT-O, polypropylne slings | Intervention Type: PROCEDURE; Name: TVT/TVT-O; Assigned to Arm(s): Ajust sling, TVT/TVT-O, polypropylne slings

Answer: D