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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence,Stress
• Intervention / Treatment: Procedure: Tension-free vaginal tape

• Study Type: Observational
• Enrollment (Actual): 1210

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; female incontinence surgery with polypropylene tape applied
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; female incontinence surgery with polypropylene tape applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation)	20 years
Quality of life assessed by RAND-36 questionnaire	The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation)	10 years
Pelvic organ prolapse assessed by POP-Q at clinical examination	Pelvic organ prolapse quantification system (POP-Q)	20 years
Pelvic organ prolapse assessed by POP-Q at clinical examination	Pelvic organ prolapse quantification system (POP-Q)	10 years
Symptoms of pelvic floor disorders assessed by PFDI questionnaire	Pelvic floor distress inventory (PFDI)	20 years
Symptoms of pelvic floor disorders assessed by PFDI questionnaire	Pelvic floor distress inventory (PFDI)	10 years

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Oslo University Hospital; St. Olavs Hospital; Alesund Hospital
• Investigators: Study Director: Torstein Baade Rø, phd prof, NTNU, Department of Clinical and Molecular Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Suburethral Slings; Tension-free vaginal tape
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: 141799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No