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

NCT04912830 | Completed

• 1 other identifier: 141799
• Study Type: observational
• Target: 1,210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence,Stress

Keywords

Surgery; Suburethral Slings; Tension-free vaginal tape

Outcome Measures

Primary Outcomes (12)

• prevalence of persistant pelvic pain after TVT surgery

  20 years

• prevalence or persistant pelvic pain after TVT surgery

  10 years

• subjective cure rate

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

  20 years

• subjective cure rate

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

  10 years

• Urinary bladder microbiota

  assessed by quadruplex PCR

  20 years

• Urinary bladder microbiota

  assessed by quadruplex PCR

  10 years

• Tension free vaginal tape placement along the urethra assessed with ultrasound

  20 years

• Tension free vaginal tape placement along the urethra assessed with ultrasound

  10 years

• Sexually active

  yes/no question

  20 years

• Sexually active

  yes/no question

  10 years

• Levator avulsion assessed by ultrasound

  20 years

• Levator avulsion assessed by ultrasound

  10 years

Secondary Outcomes (10)

• prevalence of surgical TVT removal

  20 years

• prevalence of surgical TVT removal

  10 years

• Prevalence of recurrent surgery for stress urinary incontinence

  20 years

• prevalence of recurrent surgery for stress urinary incontinence

  10 years

• Quality of life assessed by RAND-36 questionnaire

  20 years

Study Arms (2)

20 years follow-up after TVT surgery

Women who had tension free vaginal tape surgery during January 2001-December 2002 in Norway, identified in the National Incontinence Registry

Procedure: Tension-free vaginal tape

10 years follow-up after TVT surgery, age 42 or younger

Women who had tension free vaginal tape surgery and aged \< 42 years at the time of surgery during 2011-2012 in Norway, identified in the National Incontinence Registry

Procedure: Tension-free vaginal tape

Interventions

Tension-free vaginal tape PROCEDURE

female incontinence surgery with polypropylene tape applied

10 years follow-up after TVT surgery, age 42 or younger; 20 years follow-up after TVT surgery

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who had tension free vaginal tape surgery 10 and 20 years ago in Norway, identified in the National Incontinence Registry (Norsk Kvinnelig Inkontinens Register (NKIR).

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Alesund Hospital: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

• Solhaug BR, Svenningsen R, Nyhus MO, Volloyhaug I. Long-term sexual function after mid-urethral slings for stress urinary incontinence in women. Acta Obstet Gynecol Scand. 2024 Aug;103(8):1664-1671. doi: 10.1111/aogs.14894. Epub 2024 Jun 13.

  PMID: 38867580 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Torstein Baade Rø, phd prof

  NTNU, Department of Clinical and Molecular Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: October 1, 2021
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)