Urinary Incontinence,StressTVTOPPNCT04912830
Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years
An observational study of Urinary Incontinence,Stress, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 40 to 95 years, women only
- Conditions the study is for
- Urinary Incontinence,Stress
- What is being tested?
- Tension-free vaginal tape
- Type of treatment
- Surgery or procedure
- How many people
- 1,210 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2021to 15 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- Dead
- Not willing to participate
- Moved out of Norway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Urinary Incontinence,Stress
- Being tested
- Tension-free vaginal tape
- Keywords
- Surgery, Suburethral Slings, Tension-free vaginal tape
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tension-free vaginal tapeProcedure or surgery
female incontinence surgery with polypropylene tape applied
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Tension-free vaginal tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of persistant pelvic pain after TVT surgery
Measured: 20 years
prevalence or persistant pelvic pain after TVT surgery
Measured: 10 years
subjective cure rate
assessed by stress index; stress index <=3 is considered 'successful'
Measured: 20 years
subjective cure rate
assessed by stress index; stress index <=3 is considered 'successful'
Measured: 10 years
Urinary bladder microbiota
assessed by quadruplex PCR
Measured: 20 years
Urinary bladder microbiota
assessed by quadruplex PCR
Measured: 10 years
Tension free vaginal tape placement along the urethra assessed with ultrasound
Measured: 20 years
Tension free vaginal tape placement along the urethra assessed with ultrasound
Measured: 10 years
Sexually active
yes/no question
Measured: 20 years
Sexually active
yes/no question
Measured: 10 years
Levator avulsion assessed by ultrasound
Measured: 20 years
Levator avulsion assessed by ultrasound
Measured: 10 years
Secondary outcomes (10)
prevalence of surgical TVT removal
Measured: 20 years
prevalence of surgical TVT removal
Measured: 10 years
Prevalence of recurrent surgery for stress urinary incontinence
Measured: 20 years
prevalence of recurrent surgery for stress urinary incontinence
Measured: 10 years
Quality of life assessed by RAND-36 questionnaire
The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation)
Measured: 20 years
Quality of life assessed by RAND-36 questionnaire
The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation)
Measured: 10 years
Pelvic organ prolapse assessed by POP-Q at clinical examination
Pelvic organ prolapse quantification system (POP-Q)
Measured: 20 years
Pelvic organ prolapse assessed by POP-Q at clinical examination
Pelvic organ prolapse quantification system (POP-Q)
Measured: 10 years
Symptoms of pelvic floor disorders assessed by PFDI questionnaire
Pelvic floor distress inventory (PFDI)
Measured: 20 years
Symptoms of pelvic floor disorders assessed by PFDI questionnaire
Pelvic floor distress inventory (PFDI)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Oct 2021
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence,StressStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Alesund Hospital, Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Torstein Baade Rø, phd prof, Study director, NTNU, Department of Clinical and Molecular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912830
- Sponsor's protocol ID
- 141799
- Acronym
- TVTOPP
- Status last verified
- Jan 2024
- First submitted
- 28 May 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Volloyhaug I, Solhaug BR, Larssen KW, Haugum K, Nyhus MO, Svenningsen R, Afset JE. Culture-detected urinary bacteria 10-20 years after tension-free vaginal tape surgery and associations with incontinence, pelvic pain, and dissatisfaction: a cross-sectional study. BMC Urol. 2026 May 18;26(1):167. doi: 10.1186/s12894-026-02181-7.
PubMed 42151963Solhaug 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.
PubMed 38867580
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years: Success Rate and Long-term Complications
- ClinicalTrials.gov ID
- NCT04912830
- Acronym / sponsor ID
- TVTOPP / 141799
- Conditions
- Urinary Incontinence,Stress
- Keywords
- Surgery, Suburethral Slings, Tension-free vaginal tape
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,210 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Alesund Hospital, Oslo University Hospital
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 years follow-up after TVT surgery | – | Procedure: Tension-free vaginal tapeWomen who had tension free vaginal tape surgery during January 2001-December 2002 in Norway, identified in the National Incontinence Registry |
| 10 years follow-up after TVT surgery, age 42 or younger | – | Procedure: Tension-free vaginal tapeWomen 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 |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- Dead
- Not willing to participate
- Moved out of Norway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tension-free vaginal tapefemale incontinence surgery with polypropylene tape applied | Procedure or surgery | 10 years follow-up after TVT surgery, age 42 or younger, 20 years follow-up after TVT surgery |
Primary outcome
prevalence of persistant pelvic pain after TVT surgery
Time frame: 20 years
prevalence or persistant pelvic pain after TVT surgery
Time frame: 10 years
subjective cure rate
Time frame: 20 years
assessed by stress index; stress index <=3 is considered 'successful'
subjective cure rate
Time frame: 10 years
assessed by stress index; stress index <=3 is considered 'successful'
Urinary bladder microbiota
Time frame: 20 years
assessed by quadruplex PCR
Urinary bladder microbiota
Time frame: 10 years
assessed by quadruplex PCR
Tension free vaginal tape placement along the urethra assessed with ultrasound
Time frame: 20 years
Tension free vaginal tape placement along the urethra assessed with ultrasound
Time frame: 10 years
Sexually active
Time frame: 20 years
yes/no question
Sexually active
Time frame: 10 years
yes/no question
Levator avulsion assessed by ultrasound
Time frame: 20 years
Levator avulsion assessed by ultrasound
Time frame: 10 years
10 secondary outcomes
prevalence of surgical TVT removal
Time frame: 20 years
prevalence of surgical TVT removal
Time frame: 10 years
Prevalence of recurrent surgery for stress urinary incontinence
Time frame: 20 years
prevalence of recurrent surgery for stress urinary incontinence
Time frame: 10 years
Quality of life assessed by RAND-36 questionnaire
Time frame: 20 years
Quality of life assessed by RAND-36 questionnaire
Time frame: 10 years
Pelvic organ prolapse assessed by POP-Q at clinical examination
Time frame: 20 years
Pelvic organ prolapse assessed by POP-Q at clinical examination
Time frame: 10 years
Symptoms of pelvic floor disorders assessed by PFDI questionnaire
Time frame: 20 years
Symptoms of pelvic floor disorders assessed by PFDI questionnaire
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 42151963Volloyhaug I, Solhaug BR, Larssen KW, Haugum K, Nyhus MO, Svenningsen R, Afset JE. Culture-detected urinary bacteria 10-20 years after tension-free vaginal tape surgery and associations with incontinence, pelvic pain, and dissatisfaction: a cross-sectional study. BMC Urol. 2026 May 18;26(1):167. doi: 10.1186/s12894-026-02181-7.
- Derived from this study: PubMed 38867580Solhaug 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torstein Baade Rø, phd prof study director
NTNU, Department of Clinical and Molecular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence,Stress, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of persistant pelvic pain after TVT surgery (time frame: 20 years). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04912830, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.