The FAST- Study: The Follow-up After Shorter Tapes Study Effectiveness and Safety of Shorter Trans-obturator Tapes: A Prospective Observational Study From the Norwegian Female Incontinence Registry
Conditions: Stress Urinary Incontinence, Postsurgical Pain, Follow-Up Studies
Sponsor: University Hospital, Akershus

 
 
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Cover page:  
 
The FAST- Study: The Follow-up After Shorter Tapes Study 
Effectiveness and Safety of Shorter Trans-obturator Tapes: A 
Prospective Observational Study From the Norwegian Female 
Incontinence Registry   
 
NCT ID not yet assigned 
 
Date of Document: 12.06.2023 
 

 
 
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Study protocol 
The FAST- study: The Follow-up After Shorter Tapes study 
Part 2 and 3 of the PhD project for Kjersti Rimstad MD 
Effectiveness and safety of shorter trans-obturator tapes:   
 
A prospective observational study from the Norwegian Female 
Incontinence Registry 
 
Study participants and roles:  
Kjersti Rimstad, MD1, 2  
 
 
Main study doctor, corresponding author 
Marie Ellström Engh, MD, PhD1, 2 
 
Study co-supervisor, co-author 
Sissel H. Oversand, MD, PhD3, 4 
 
Study co-supervisor, co-author 
Rune Svenningsen, MD, PhD2, 3, 4 
 
Study supervisor, senior author 
 
1Department of Obstetrics and Gynaecology, Akershus University Hospital, Oslo, Norway 
2Faculty of Medicine, University of Oslo 
3Department of Obstetrics and Gynaecology, Oslo University Hospital, Ullevål, Oslo, Norway 
4The Norwegian Female Incontinence Registry 
 
Collaborators 
• 
Tomislav Dimoski, MBA, System developer for the Norwegian Female Incontinence Registry 
(NFIR) will be credited under Acknowledgements 
• 
Jon Michael Gran, biostatistician at the Center for Biostatistics and Epidemiology at Oslo University 
Hospital will be credited under Acknowledgement 
 
Funding:  
Funded by Akershus University Hospital and the University of Oslo 
 
Table of contents: 
 
Title, participants and affiliations 
…….……………………………………… 1 
Funding  
…….……………………………………… 1 
Table of contents 
…….……………………………………… 1 
List of abbreviations 
…….……………………………………… 2 
Background 
…….……………………………………… 2 
Research questions, hypotheses, 
theoretical approach and 
methodology 
 
 
…….……………………………………… 4 
User participation 
…….……………………………………… 7 
Ethical considerations 
…….……………………………………… 7 
Potential impact of the proposed 
research 
……………………………………………. 7 
Publication of results 
…….……………………………………… 7 
References 
…….……………………………………… 8 
 

 
 
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List of abbreviations 
SUI 
 
Stress Urinary Incontinence 
MUS  
Mid-urethral Sling 
MUI 
 
Mixed Urinary Incontinence 
NFIR  
Norwegian Female Incontinence Registry 
TVT-O  
Inside-out tension-free tape obturator 
MUCP  
Maximum urethral closure pressure 
OUS 
 
Oslo University Hospital 
AHUS  
Akershus University Hospital 
REK 
Regional Committee for Medical and Health Research Ethics in the Southeast Norway 
TVT  
tension free vaginal tape 
SIMS 
Single incision mini-slings 
TVT-A 
TVT-O Abbrevo 
TPUS 
trans-perineal ultrasound 
PFIQ-7 
Pelvic Floor Impact Questionnaire 
QoL 
quality of life 
2D UL 
Two-dimensional Ultrasound 
3D UL 
Three-dimensional Ultrasound 
 
Background: 
Stress urinary incontinence can significantly diminish the quality of life for many women, limiting their 
physical activity and impairing sexual function (1). This condition, defined as urinary leakage when 
coughing, sneezing, or exerting physical effort, has a prevalence of 12-46 % among the general female 
population (2, 3). For the past two decades, mid-urethral sling (MUS) procedures have been the dominant 
surgical treatment for SUI and stress-dominant mixed urinary incontinence (MUI). The traditional MUS 
procedures involve placing a polypropylene mesh under the urethra either in front of the bladder, passing 
through the pelvis to the lower abdomen (tension-free vaginal tape (TVT))(4)), or to the side of the pelvis in 
the groin area (tension-free vaginal tape obturator inside-out (TVT-O)) (5) (Fig. I). These traditional 
techniques have well-documented, long-lasting results (6, 7), and have improved the quality of life for many 
women with SUI (8, 9). MUS procedures have good subjective and objective results for both SUI and stress-
dominant MUI and are generally considered safe with low rates of complications (2). 
However, in recent years there has been increasing awareness of long-term complications associated with 
synthetic materials used in these slings, such as chronic pain, dyspareunia, and voiding dysfunction (10). 
Although these complications are rare, affected women may experience a lifetime of severely reduced 
quality of life, even if the synthetic material is entirely removed (11). As a result, the health regulatory 
bodies, hospital administrators, individual surgeons and patients have started to seek out alternative surgical 
methods.  
 
Single incision mini-slings (SIMS) such as Ajust (Fig. I), which contain much less synthetic mesh than 
traditional slings, were introduced worldwide in 2006 (12). Later, in 2010, the intermediate sling TVT-O 
Abbrevo (TVT-A), was introduced hoping to improve the clinical performance of shorter slings (Fig. I) (13). 
However, there is still a significant knowledge gap regarding short- and long-term results of these new and 
shorter slings, particularly in terms of complications such as chronic pelvic pain. While some studies have 
shown promising short-term results for SIMS and intermediate slings, these studies are often small and 
hampered by selection bias and high rates of lost follow-up (14-22).  
 
FIG.I: The photos depict the traditional slings (TVT and TVT-O), SIMS Ajust and TVT-A. 
TVT (23) 
  TVT-O (24) 
       

 
 
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SIMS Ajust (25) 
 TVT-A (26)  
                    
 
Given that shorter slings could represent a middle ground between the risk of severe complications and a 
diminished quality of life (QOL) due to untreated stress urinary incontinence, data on the long-term effects 
and safety of the newer shorter slings are urgently needed. Retrieving such knowledge would enable the 
updating of surgical guidelines and provide patients considering surgical options with evidence-based 
recommendations. 
 
In Norway more than 90% of all female incontinence operations are carried out in public hospitals, and since 
2017 the coverage of reporting female incontinence operations has been more than 98 % from public 
hospitals to the mandatory Norwegian Female Registry (NFIR) (27). This Registry, established in 1998 by 
The Norwegian Urogynecology Group, is now a compulsory, nationwide quality registry based at Oslo 
University Hospital (27, 28).  Reliable data are collected before surgery, at the time of surgery and at follow-
up consultations 6-12-months and 3 years after the surgery. The 6-12 months data has good coverage and 
will be used in the first part of this PhD project (Part I: REK 22/397503). However, the 3-years reporting has 
low coverage and are mostly subjective questionnaire-based data. According to the yearly public report from 
the NFIR, hospitals using the SIMS Ajust and TVT-A slings seem to have fewer short-term complications 
than hospitals using the traditional slings (either retropubic or transobturator sling) (29). However, there is 
still a disagreement about whether the SIMS Ajust and TVT-A, due to their shorter length, are as effective as 
the traditional slings. Since its introduction, the TVT-A has mainly been classified as a TVT-O sling in the 
NFIR, and any potential differences in results and complications from regular TVT-O slings have therefore 
not been evaluated. Furthermore, there are to date only a few published studies evaluating the effectiveness 
and complication rates of the SIMS Ajust and TVT-A (14-22, 30-33). Therefore, it would be of great benefit 
to surgeons and patients if better scientific data on the short- and long-term effectiveness and complication 
rates of these slings could be evaluated. 
 
Most of the 39 departments offering female incontinence surgeries in Norway use traditional MUS. 
However, one of the largest hospitals, Akershus University hospital (AHUS), has been using shorter slings as 
their preferred MUS since 2009, initially SIMS Ajust and later TVT-A. At AHUS, we therefore have a 
unique opportunity to study the long-term results and complication rates of shorter slings by inviting women 
back for a long-term follow-up after undergoing sling surgery at AHUS. In addition to quality of life, 
complications, and patient satisfaction, this follow-up provides the possibility of investigating sling position 
using 2D dynamic and 3D transperineal ultrasound (TPUS) (34-37). This innovative technique that 
dynamically investigates the pelvic floor and sling placement is not widely used in Norway, but is available 
at AHUS, which also has expertise in advanced ultrasound within the research group. How the positioning of 
intermediate slings under the urethra may affect long-term success rates and adverse events is largely 
unknown. Studies on traditional slings suggest that placement more proximal or distal to the mid-part of the 
urethra is associated with poorer outcomes (34-36). 
Whether this is coincidental or represents an actual association between sling position and long-term success 
and complication rates is not established for intermediate slings. To go even further, we will evaluate if there 
is an “optimal sling placement zone”, particularly for shorter slings. This information is currently lacking and 
makes it difficult for gynaecologists evaluating patients in need of repeat surgery, due to either treatment 
failure or long-term complications. Understanding the biomechanical effects visualized by ultrasound of the 
increasingly popular shorter slings would be pioneering work and enable researchers and doctors to further 
develop the treatment techniques for female incontinence.  
 
 

 
 
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Research questions and hypotheses, theoretical approach and methodology  
 
 
PhD-project, Part 2 
Our over-all aim is to evaluate long-term subjective and objective outcomes of shorter slings.   
Study design: Prospective observational study   
 
1) Long-term subjective outcomes 
Study population: Women treated with SIMS Ajust (n = 744) at Akershus University Hospital between 2009 
and 2016 and Intermediate sling TVT-A (n= 318) at Akershus University Hospital between 2016 and 2020.  
Follow-up: Potential study participants for both groups will be identified in the local quality database for 
female incontinence surgery (local NFIR) at AHU S and invited to a long-term follow-up (4-14 years) with 
questionnaires. The following questionnaires will be sent electronically to the patients together with study 
invitation and consent form: The validated NFIR questionnaire, the validated Pelvic Floor Impact 
Questionnaire (PFIQ-7) (38, 39) as well as additional questions regarding pain (40).   
a. Primary outcomes: Long-term subjective cure rate. 
• 
Long-term subjective cure is estimated by calculating a stress urinary incontinence index score 
(SUIS) from 4 clusters of questions measuring degree of symptom bother in the validated NFIR 
questionnaire, from 0 (no symptoms) to 12 (high symptom load) where a score < 3 is defined as 
subjective cure (41).  
 
b. Secondary outcomes: Long-term treatment satisfaction scores, quality of life score and 
complication rates. 
• 
Differences in improvement of quality-of-life using a Quality-of-life index score (QoLIS) generated 
from 4 questions in the NFIR questionnaire measuring QoL impact. This index ranges from 0 
(excellent quality of life) to 16 (poor quality of life) (41). In addition, the Pelvic Floor Impact 
Questionnaire (PFIQ-7) (38, 39) will be used to further evaluate the Quality-of-life impact.  

 
 
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• 
Differences in treatment satisfaction rates are defined as the percentage of women answering “very 
satisfied with treatment” given the options “very satisfied”, “moderately satisfied”, “neither satisfied 
nor dissatisfied”, “moderately dissatisfied” or “very dissatisfied” in the NFIR questionnaire.   
• 
Differences in total complication rates (all types included), re-operation rates, vaginal tape 
exposure, persistent and de novo urgency incontinence and prolonged pain.  
o 
Persistent and de novo urgency incontinence is calculated from the NFIR questionnaire 
using 4 clusters of questions that generate an urgency urinary incontinence score (UUIS) 
quantifying the degree of urgency symptom bother from 0 (no symptoms) to 8 (high 
symptom load) (41). De novo urgency incontinence will be defined as having had a UUIS 
of ≥ 4 at the long term follow up in women who had no urgency incontinence symptoms 
before surgery (preoperative urgency urinary incontinence score = 0). 
o 
 Differences in prolonged pain defined as postoperative pain more than 3 months after 
surgery in the NFIR questionnaire or having had treatment for pain caused by the surgery, 
e.g removal of the sling or part of the sling. Patients having persistent ongoing pain will 
further be asked to answer a newly developed non-validated NFIR pain questionnaire (40).   
 
2) Long-term objective outcomes 
Study population: The 318 women having been treated with the currently most used shorter sling (TVT-A) at 
Akershus University Hospital between 2016 and 2020 will be invited to a physical follow-up were they will 
undergo a clinical examination including assessment of objective cure, sling erosions and development of 
pelvic organ prolapse using the POP-Q system (42).  
Exposure: Having had TVT-A sling operation at AHUS.      
a. Primary outcomes: Long-term objective cure rates.  
• 
Objective cure will be defined as having no leakage (0 g) at a cough-jump pad weighing stress 
test (43). 
 
b. Secondary outcomes: The same as defined under 1) Long-term subjective outcomes. 
• 
In addition, we will evaluate differences in the rate of mesh exposures and the development of 
pelvic organ prolapse (POP) using the POP-Q evaluation system (42). 
• 
The severity of tape exposure will be evaluated using the ICS and IUGA prosthesis and graft 
complication classification system (44). In addition, we will evaluate the intervention for 
surgical complications using the Clavien-Dindo Classification (45, 46).  
 
PhD-project, Part 3 
We will study the positioning of the shorter sling TVT-A under the urethra using dynamic 2D and 3D 
ultrasound. We will evaluate if there is an “optimal sling placement zone” for shorter slings.  
  
  (35) 

 
 
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Our aim is to study the association between sling position, tension and anchoring under the urethra, and 
subjective and objective cure rate, and long-term complication rates, especially chronic pelvic pain.   
Our null hypothesis is that there are no associations between sling position, tension or anchoring of the 
tape and subjective and objective outcomes including complications such as chronic pain development.   
Study design: Prospective observational study   
Study population: 318 women having had surgery with the intermediate sling TVT-A at AHUS between 
2016 and 2020. 
Follow-up: Women who consent to study participation and attend the physical follow-up will undergo a 
clinical examination that includes a transperineal ultrasound (TPUS) examination in the dorsal lithotomy 
position using a 3,5-6 MHz curved array abdominal probe (47). The TPUS volumes and images will be 
obtained with an empty bladder at rest and under full Valsalva (48).   
Exposure: Position, tension (shape) and anchoring of the sling, and measuring sling position in relation to 
well-defined anatomical markers.  
a. Primary outcomes: Any association between sling position, tension or anchoring and 
subjective and objective cure rate, complication rates and especially the development of 
chronic pelvic pain. For the definitions of cure rates, see under part 2. 
b. Secondary outcomes: Any association between sling position, tension or anchoring and 
long-term complications, especially chronic pelvic pain, see part 2. 
 
Statistics, power and sample size:    
PhD-project, Part 2  
This is a follow-up study of all women having been operated at AHUS with SIMS Ajust or TVT-A in the 
study period. Few studies with long-term outcomes after shorter slings have been published. The first part of 
the long-term follow-up will therefore be a prospective follow-up study with no group comparisons. For this 
part, power calculations are not feasible as all women having had SIMS Ajust or TVT-A in the study period 
consenting to study participation will be analysed for subjective outcomes, whereas all women in the TVT-A 
group consenting to study participation will be analysed for objective outcomes.   
 
PhD-project, Part 3  
For the transperineal ultrasound (TPUS) part of the project, various outcomes will be evaluated based on sub 
urethral sling position, tension and anchoring. As there is little scientific published data on how sling 
placement affect subjective and objective outcomes of sling surgeries, a pre-study sample size estimation 
must in part be made on best clinical guess. Based on the following assumptions:  
We estimate that 80 % of the women will have the sling placed in the “optimal position” and 20 % outside 
the optimal position as shown in a small study published in 2017 by Hegde and co-workers (37). Therefore, 
the estimated group ratio will be 1:4.  
A clinically relevant effect size (group difference) regarding subjective outcomes is not established, but 
based on our clinical experience, we have set the minimal relevant group difference in success rate to 30 % 
(85 % subjectively cured in the “optimal position” group vs 55 % in the “non-optimal position group”).  
With a significance level (α) of 0,05 and a statistical power (β) of 80%, the estimated sample size to be 
included for TPUS evaluation is 107 women (37). Even though we invite all 318 TVT-A women to attend 
the physical long-term follow-up with ultrasound evaluation, realistically we estimate that only 50 % will 
want to participate. Even with 50 % participation we should, based on our sample size calculation, be able to 
draw valid conclusions. 
 
 

 
 
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Risk evaluation and countermeasures 
The main risk to the project is patient inclusion. To get robust and valid scientific data we are depending on 
women being willing to participate in the project with clinical examinations and ultrasound measurements. 
Based on previous experience, Norwegian women usually do want to participate in long-term follow-up 
studies. In the 10-year follow-up study of retropubic TVTs conducted by the main supervisor Svenningsen 
89 % consented to study participation, and 60 % to a physical follow-up (6). Even a conservative estimate of 
50 % would therefore be enough to draw valid conclusions. However, if less than 50 % agree to study 
participation, we do have the possibility to extend the study period to include women operated in 2021. 
According to the work plan for the PhD project (below) these women will then be evaluated in 2024 at the 
earliest and as such have follow-up of minimum 4 years. 
 
User Participation 
The project has two user representatives, Trude Lyng as part of NFIRs national Advisory Unit and Lene 
Marie Brobakken as user representative at the Women’s Clinic, AHUS. They have both participated in the 
planning of the project and given valuable comments in developing the study protocol. Both have agreed to 
stay on as part of the project group. We plan on having quarterly meetings with the user representatives 
throughout the whole project period.  
Ethical considerations 
The Department Head at AHUS has already approved the study. Furthermore, the study will be sought 
approved by NFIR Management team, NFIRs professional council, The Data Protection Officer at AHUS as 
well as the Regional Committee for Medical and Health Research Ethics in the Southeast of Norway (REC 
South East). Signed consent will be obtained from all study participants.  
Study participants will only be examined using established techniques for the evaluation of women after 
incontinence surgery, the exception being the 3D ultrasound examination. None of them involves any 
additional risk for the participants.  
Questionnaires and consent forms will be sent electronically and stored at the Services for Sensitive Data 
(TSD), as well as the research server at AHUS. Study participants who report persistent or recurring 
incontinence as well as any long-term complications related to the slings will be offered a full new clinical 
evaluation. 
 
Potential impact of the proposed research 
The proposed research has the potential to significantly impact the surgical management and treatment of 
women with urinary incontinence, both nationally and abroad. This study aims to address critical knowledge 
gaps that, when filled, could improve the quality of life for women with this condition. The study's 
pioneering approach of establishing an "optimal placement zone" for slings may prove to be an innovative 
tool in decision-making after failed surgery and in women experiencing severe long-term complications, 
such as chronic pelvic pain. Providing women with evidence-based data on short- and long-term success 
rates of shorter slings and the incidence of long-term risks for severe complications, such as chronic pain, is 
highly sought after in the ongoing controversy surrounding the use of synthetic implants vaginally. 
 
Publication of results 
The results from the PhD project will be published as three Papers in internationally peer-reviewed journals. 
Furthermore, the study´s findings will be presented at the Annual Meeting of The Norwegian Society for 
Gynecology and Obstetrics, and at the Yearly NFIR meeting, and at international Urogynecology 
conferences such as the Annual Meeting of the International Continence Society. This is crucial in ensuring 

 
 
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that new knowledge derived from this project reaches surgeons in Norway and abroad who use these 
methods. The results will be communicated to all women, in cooperation with the user representatives, 
through the hospital Blogs, related websites and research meetings as well as through podcasts and women’s 
magazines. 
 
6. References 
 
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37. 
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