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

Urinary Incontinence,Stress Clinical Trial

— TVTOPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04912830
• Other study ID #: 141799
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: February 15, 2023

Study information

• Verified date: January 2024
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1210
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

Procedure:
• Tension-free vaginal tape
female incontinence surgery with polypropylene tape applied

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Alesund Hospital, Oslo University Hospital, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of persistant pelvic pain after TVT surgery		20 years
Primary	prevalence or persistant pelvic pain after TVT surgery		10 years
Primary	subjective cure rate	assessed by stress index; stress index <=3 is considered 'successful'	20 years
Primary	subjective cure rate	assessed by stress index; stress index <=3 is considered 'successful'	10 years
Primary	Urinary bladder microbiota	assessed by quadruplex PCR	20 years
Primary	Urinary bladder microbiota	assessed by quadruplex PCR	10 years
Primary	Tension free vaginal tape placement along the urethra assessed with ultrasound		20 years
Primary	Tension free vaginal tape placement along the urethra assessed with ultrasound		10 years
Primary	Sexually active	yes/no question	20 years
Primary	Sexually active	yes/no question	10 years
Primary	Levator avulsion assessed by ultrasound		20 years
Primary	Levator avulsion assessed by ultrasound		10 years
Secondary	prevalence of surgical TVT removal		20 years
Secondary	prevalence of surgical TVT removal		10 years
Secondary	Prevalence of recurrent surgery for stress urinary incontinence		20 years
Secondary	prevalence of recurrent surgery for stress urinary incontinence		10 years
Secondary	Quality of life assessed by RAND-36 questionnaire	The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation)	20 years
Secondary	Quality of life assessed by RAND-36 questionnaire	The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation)	10 years
Secondary	Pelvic organ prolapse assessed by POP-Q at clinical examination	Pelvic organ prolapse quantification system (POP-Q)	20 years
Secondary	Pelvic organ prolapse assessed by POP-Q at clinical examination	Pelvic organ prolapse quantification system (POP-Q)	10 years
Secondary	Symptoms of pelvic floor disorders assessed by PFDI questionnaire	Pelvic floor distress inventory (PFDI)	20 years
Secondary	Symptoms of pelvic floor disorders assessed by PFDI questionnaire	Pelvic floor distress inventory (PFDI)	10 years