Actively Recruiting

Age: 25Years - 90Years
FEMALE
Healthy Volunteers
NCT06731985

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

Led by University Hospital, Akershus · Updated on 2024-12-13

750

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 25Years - 90Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women operated for stress urinary incontinence with TVT-O Abbrevo or Ajust incontinence sling between 2009 and 2020.
Not Eligible

You will not qualify if you...

  • Women who had other types of incontinence surgeries or slings besides TVT-O Abbrevo or Ajust.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Akershus University Hospital

Lorenskog, Norway, 1478

Actively Recruiting

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Research Team

K

Kjersti Rimstad Rimstad, Cand.Med.

CONTACT

A

Anna Marie Ellstrom Engh Professor, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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