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Completed

NCT Number: NCT04912830

Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years

Over the past 5-7 years there has been increasing concern about the use of polypropylene tapes in female incontinence surgery. There has been a special focus on pain in the vagina and lower abdomen and pain during sexual intercourse. Some have also asked if the polypropylene tape could cause impairment of the immune system leading to allergy, connective tissue disorders etc. There are still only a few publications on complications after sling surgery.

In Norway it is mandatory to register all incontinence surgery in the National incontinence registry (Norsk Kvinnelig Inkontinens Register (NKIR). In 2019 >99 % of all procedures were registered in this registry. Data about type and severity of incontinence are registered, as well as complications at surgery. The same data are entered at a 6 months and 3 years follow up. Data for the follow up visits are not complete. The NKIR registry and other similar registries have been criticized for not following the women long enough and therefore missing important information regarding long-term complications. Few studies have followed the women for a longer time after surgery. The main aim of this study is to find the prevalence of women still satisfied with the TVT surgery and the prevalence of long-term complications after 10 and 20 years.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • had TVT surgery in Norway January 2001-December 2002 (20-years follow-up cohort)
  • had TVT surgery in Norway, < 42 years at the time of surgery in 2011-2012 (10-years follow-up cohort)

Exclusion criteria

  • Dead
  • Not willing to participate
  • Moved out of Norway

Treatment and study plan

tension-free vaginal tape

Procedure

female incontinence surgery with polypropylene tape applied

Primary outcomes

  1. prevalence of persistant pelvic pain after TVT surgery

    Time frame: 20 years

  2. prevalence or persistant pelvic pain after TVT surgery

    Time frame: 10 years

  3. subjective cure rate

    Time frame: 20 years

    assessed by stress index; stress index <=3 is considered 'successful'

  4. subjective cure rate

    Time frame: 10 years

    assessed by stress index; stress index <=3 is considered 'successful'

  5. Urinary bladder microbiota

    Time frame: 20 years

    assessed by quadruplex PCR

  6. Urinary bladder microbiota

    Time frame: 10 years

    assessed by quadruplex PCR

  7. Tension free vaginal tape placement along the urethra assessed with ultrasound

    Time frame: 20 years

  8. Tension free vaginal tape placement along the urethra assessed with ultrasound

    Time frame: 10 years

  9. Sexually active

    Time frame: 20 years

    yes/no question

  10. Sexually active

    Time frame: 10 years

    yes/no question

  11. Levator avulsion assessed by ultrasound

    Time frame: 20 years

  12. Levator avulsion assessed by ultrasound

    Time frame: 10 years

Secondary outcomes

  1. prevalence of surgical TVT removal

    Time frame: 20 years

  2. prevalence of surgical TVT removal

    Time frame: 10 years

  3. Prevalence of recurrent surgery for stress urinary incontinence

    Time frame: 20 years

  4. prevalence of recurrent surgery for stress urinary incontinence

    Time frame: 10 years

  5. Quality of life assessed by RAND-36 questionnaire

    Time frame: 20 years

    The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation)

  6. Quality of life assessed by RAND-36 questionnaire

    Time frame: 10 years

    The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation)

  7. Pelvic organ prolapse assessed by POP-Q at clinical examination

    Time frame: 20 years

    Pelvic organ prolapse quantification system (POP-Q)

  8. Pelvic organ prolapse assessed by POP-Q at clinical examination

    Time frame: 10 years

    Pelvic organ prolapse quantification system (POP-Q)

  9. Symptoms of pelvic floor disorders assessed by PFDI questionnaire

    Time frame: 20 years

    Pelvic floor distress inventory (PFDI)

  10. Symptoms of pelvic floor disorders assessed by PFDI questionnaire

    Time frame: 10 years

    Pelvic floor distress inventory (PFDI)

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Alesund Hospital
  • Oslo University Hospital
  • St. Olavs Hospital

Registry information

Official study title

Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years: Success Rate and Long-term Complications

Acronym: TVTOPP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2021
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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