About this trial
Urinary incontinence after pregnancy and labor affects 1 in 3 women and has a negative impact on quality of life (QOL), limiting women's physical activity and impairing sexual function. The traditional surgical method treating female urinary incontinence is to implant a sub-urethral synthetic sling, the currently preferred method in Norway. The majority of women treated with synthetic slings obtain great improvement in QOL, but a few experience severe complications including chronic pelvic pain. Several countries, therefore, have reverted to older, less effective surgical methods to avoid synthetic material. Awareness of severe complications has, in some Norwegian hospitals, led to a shift in technique towards shorter slings. With shorter slings, the goal is to achieve the same grade of continence as traditional slings, but with fewer serious complications. The long-term results and complications of these shorter slings are mostly unknown. Akershus University Hospital (AHUS) shifted to shorter slings early, in 2009, using a single incision mini-sling (SIMS) Ajust. Due to costs, AHUS changed to the intermediate sling TVT-O Abbrevo in 2016.
Through this study, we hope to establish if shorter slings have the same long-term results as traditional slings, and to investigate if shorter slings are safer than traditional slings, with less long-term complications, such as chronic pelvic pain. We plan to perform a long-term follow-up of women having had surgery with shorter slings at AHUS.
All patients operated with either SIMS Ajust or TVT-O Abbrevo at AHUS between 2009 and 2020 will be invited to a long-term follow-up. The study participants will be asked to fill in validated questionnaires regarding symptoms of urine leakage, QOL, any chronic pain related to the surgery, debut of pain, level of pain and any treatments for the pain. All women treated with the current used sling Abbrevo is invited to a physical examination including testing of their voiding function and a gynecologic examination to check for complications.
2D- and 3D ultrasound scans will be done on the TVT-O Abbrevo group to evaluate the position-, attachment- and any misplacement of the sling.
Women experiencing insufficient long-term results, such as chronic pain, will be offered a full examination and treatment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All women operated for stress-urinary incontinence with TVT-O Abbrevo of Ajust incontinence sling between 2009 and 2020.
Disqualifiers
Women operated with other incontinence operations or slings.
Trial population
Female incontinence patients operated at AHUS between 2009 and 2021, aged between 25 and 90.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
NFIR questionnaire subjective cure rate
Rate of subjective cure defined as a stress urinary incontinence index score \<3 estimated by calculating a stress urinary incontinence index score from 4 clusters of questions in the NFIR questionnaire measuring degree of symptom bother from 0 to 12.
Objective cure rate on validated NFIR stress test
Objective cure defined as 0g leakage at a cough-jump pad weighing stress test.
Secondary outcomes
NFIR questionnaire quality of life score
Level of quality of life score generated from 4 questions in the NFIR questionnaire measuring QoL impact. This index ranges from 0 (excellent quality of life) to 16 (poor quality of life).
Long-term complications
Rate of complications at long-term follow-up clinical examination.
NFIR treatment satisfaction rate
Rate of women answering "very satisfied with treatment" given the options "very satisfied", "moderately satisfied", "neither satisfied nor dissatisfied", "moderately dissatisfied" or "very dissatisfied" in the NFIR questionnaire.
NFIR total complication rate
Total complication rates in the NFIR questionnaire.
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.