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The Follow-up After Shorter Tapes Study. Effectiveness and Safety of Shorter Trans-obturator Tapes.

NCT06731985 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 750

Last updated 2024-12-13

No results posted yet for this study

Summary

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.

Conditions

  • Stress Urinary Incontinence
  • Postsurgical Pain
  • Follow-Up Studies

Sponsors & Collaborators

  • University Hospital, Akershus

    lead OTHER

Principal Investigators

  • Anna Marie Ellstrom Engh Professor, PhD · Akershus university hospital HC

Eligibility

Min Age
25 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-24
Primary Completion
2026-05-18
Completion
2026-10-31

Countries

  • Norway

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06731985 on ClinicalTrials.gov