Urinary IncontinencePregnanTNCT02999347
Pregnancy After Tension-free Vaginal Tape and Other Mid-urethral Sling Procedures
An observational study of Urinary Incontinence and Urinary Stress Incontinence, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to determine the interactions between pregnancy and urinary stress incontinence in women with a mid-urethral sling (MUS). The specific aims of the 2 sub studies are: Study 1: The main aims of Study 1 are to evaluate any potential impact on urinary stress continence after a… Read more about this study
- Who is it for?
- Ages Up to 45 years, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Stress Incontinence, Pregnancy Complications
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2014to Aug 2018
- 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 Up to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women included in the Norwegian Female Incontinence Registry.
Who may be able to join
- Cases, consisting of women identified by the coupling of The Norwegian female incontinence registry and The medical birth registry of Norway as having undergone at least one pregnancy/delivery after their MUS surgery
- Controls, consisting of randomly selected women from Ullevål Hospital registered in the The Norwegian female incontinence registry with MUS surgery. Every case will be matched with two controls. The women will be matched with the study cases' age and year of surgery (+- 2 years of age if a perfect match is not obtainable). These controls have not undergone a subsequent pregnancy/delivery.
Who cannot join
- The only exclusion criterion will be the inability to give consent either due to reduced mental capacity or the lack of language skills in Norwegian or English.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Gynekologisk avdeling, Oslo Universitetssykehus Ullevål
Oslo, 0424
About this study
Official title: The PregnanT-study: Pregnancy Outcomes After TVT and Other Mid-urethral Sling (MUS) Procedures
The purpose of this study is to determine the interactions between pregnancy and urinary stress incontinence in women with a mid-urethral sling (MUS). The specific aims of the 2 sub studies are:
Study 1:
Read more
The main aims of Study 1 are to evaluate any potential impact on urinary stress continence after a pregnancy/delivery following MUS surgery, and to evaluate any potential differences in continence status based on the mode of delivery for these women.
Study 2:
The aim of Study 2 is to examine how obstetric factors may affect the degree of incontinence in women registered in The Norwegian female incontinence registry prior to surgical treatment. In addition, we want to explore if there are obstetric risk factors predicting failure of a MUS surgery performed after pregnancy/delivery.
Read the detailed description
Stress urinary incontinence (SUI) is defined as involuntary leakage of urine on effort, or exertion, or on sneezing or coughing or laughing. This is the commonest form of incontinence in women affecting one in three over the age of 18 years with significant impact on their quality of life.
The Tension-free vaginal tape (TVT) was introduced in 1996 and has become one of the most widely used incontinence operations worldwide. In 2001, Delorme described a new mid-urethral sling using an outside-in transobturator approach, where the tape is inserted through the skin and the obturator foramen into the vagina (TOT). DeLeval developed a similar approach in 2003, where the tape is inserted inside-out from the vagina through the obturator foramen and the skin (TVT-O). TVT, TOT and TVT-O are collectively known as mid-urethral sling (MUS) operations.
Mid-urethral sling (MUS) operations can be performed as minimal invasive surgery in local anesthesia with short operative time and minimal surgical dissection. This type of surgery is now considered to be the standard surgical management for both SUI and mixed urinary incontinence (MUI) in which there is a predominant stress component. The short- and long term results are comparable to the Burch colposuspension and have been well documented.
Surgical treatment of SUI and MUI is generally recommended after the completion of childbearing for several reasons, one reason being that numerous studies have demonstrated pregnancy and delivery to be risk factors for SUI. Furthermore, in women treated with MUS, a new pregnancy and delivery might, in theory, change the position of the tape leading to the recurrence of incontinence symptoms. Women treated with MUS, who have recurrence of their SUI and MUI, also have a poorer outcome if given a second procedure (either a MUS or a bulking agent).
There is very limited knowledge about the consequences of a pregnancy in women who have undergone a mid-urethral sling operation, and only a few case reports exist in the literature. There is currently no consensus on either the management of a subsequent pregnancy or the mode of delivery after MUS surgery. Some clinical experts have claimed that vaginal delivery, where the baby's head exerts pressure on the anterior vaginal wall, may cause the tape to dislocate with potential injury to the bladder and urethra15. During the last decade, there has been a marked increase in the number of mid-urethral sling operations. This increase is probably due to the excellent short and long-term results, with less morbidity and a shorter hospital stay compared to colposuspension (the previous "gold standard" for SUI). It may therefore be expected in the future that more women of fertile age will request surgical treatment of SUI before the completion of their childbearing.
Several observational studies have shown that SUI is more prevalent in patients who have delivered at least one child. Obstetrical factors such as vaginal birth vs. elective cesarean section, parity, age at first pregnancy/birth and operative vaginal delivery have been associated with an increased risk of developing SUI. In addition, anal incontinence in fertile women is associated with SUI, probably due to more risk of pudendal nerve damage after an obstetrical anal sphincter injury with subsequent anal incontinence. Although obstetric factors are associated with the development of SUI, there are no studies on whether the same factors may negatively impact the outcome after SUI surgery.
The Norwegian Female Incontinence Registry (NFIR) was established in 1998. The purpose of the registry is to ensure the quality of incontinence surgery in Norway and that each department should be able to keep track of their results and use the information to improve the quality of their surgery. The majority of gynecological departments in Norway performing incontinence surgery report preoperative subjective and objective data, the type of incontinence procedures and complications, as well as 6-12 months' subjective and objective follow-up data to the registry. There are currently about 20 000 patients recorded in the registry, in a deidentified form, which means that only the Department that performed the operation has access to patient identity through a coded patient ID number (NFIR-number). Approximately 5 000 of these women are registered as being of childbearing age (< 45 years old) at the time of operation. In 2013 the NFIR obtained status as a National Quality Registry.
- Keywords
- Treatment Outcome, Mid-urethral slings, Gynecologic Surgery Procedures
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Women having undergone at least one pregnancy/delivery after their MUS surgery | |
| Controls | Every case will be matched with two controls. The controls will be matched with the study cases' age and year of surgery (+- 2 years of age if a perfect match is not obtainable). These controls have not undergone a subsequent pregnancy/delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective stress incontinence rates
Defined as the percentage of women having a stress incontinence index score < 5 on the validated questionnaire compared to women of equal age and follow-up time (also having undergone MUS surgery) not having undergone a subsequent delivery (controls)
Measured: Up to ten years
Treatment satisfaction rate
Defined as the percentage of women stating "very satisfied" on the validated questionnaire in both cases and Controls.
Measured: Up to ten years
The percentage of women not using urinary incontinence pads
Measured: Up to ten years
Any potential differences in subjective stress continence rates, the rate of women not using pads and treatment satisfaction rates based on the mode of delivery (spontaneous vaginal, operative vaginal and cesarean section)
Measured: Up to ten years
Secondary outcomes (7)
Any potential adverse effects of undergoing a subsequent delivery after previous MUS surgery
Measured: Up to ten years
The continence status during pregnancy (before delivery) and whether any subjective incontinence was persistent or transient after delivery
Assesed on a validated questionnaire
Measured: Up to ten years
The effect of time from MUS to subsequent delivery on stress continence status
Measured: Up to ten years
The impact on stress continence status from having undergone more than one subsequent delivery after MUS
Measured: Up to ten years
Differences in urgency score between controls and cases
Measured: Up to ten years
Any differences in subjective stress continence rates, treatment satisfaction rates or the rate of women not using pads when having undergone a subsequent delivery after previous MUS surgery based on the specific type of MUS (TVT, TOT or TVT-O)
Measured: Up to ten years
The effect of breastfeeding on subjective urinary stress continence rates having undergone pregnancy/delivery after MUS
Measured: Up to ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startAug 2014
- Primary completionApr 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole Aleksander Jonsbu Dyrkorn, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999347
- Sponsor's protocol ID
- 2015/434REK
- Acronym
- PregnanT
- Status last verified
- Feb 2019
- First submitted
- 19 Dec 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PregnanT-study: Pregnancy Outcomes After TVT and Other Mid-urethral Sling (MUS) Procedures
- ClinicalTrials.gov ID
- NCT02999347
- Acronym / sponsor ID
- PregnanT / 2015/434REK
- Keywords
- Treatment Outcome, Mid-urethral slings, Gynecologic Surgery Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 21 Dec 2016 (estimated)
- 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.
The purpose of this study is to determine the interactions between pregnancy and urinary stress incontinence in women with a mid-urethral sling (MUS). The specific aims of the 2 sub studies are:
Study 1:
The main aims of Study 1 are to evaluate any potential impact on urinary stress continence after a pregnancy/delivery following MUS surgery, and to evaluate any potential differences in continence status based on the mode of delivery for these women.
Study 2:
The aim of Study 2 is to examine how obstetric factors may affect the degree of incontinence in women registered in The Norwegian female incontinence registry prior to surgical treatment. In addition, we want to explore if there are obstetric risk factors predicting failure of a MUS surgery performed after pregnancy/delivery.
Detailed description
Stress urinary incontinence (SUI) is defined as involuntary leakage of urine on effort, or exertion, or on sneezing or coughing or laughing. This is the commonest form of incontinence in women affecting one in three over the age of 18 years with significant impact on their quality of life.
The Tension-free vaginal tape (TVT) was introduced in 1996 and has become one of the most widely used incontinence operations worldwide. In 2001, Delorme described a new mid-urethral sling using an outside-in transobturator approach, where the tape is inserted through the skin and the obturator foramen into the vagina (TOT). DeLeval developed a similar approach in 2003, where the tape is inserted inside-out from the vagina through the obturator foramen and the skin (TVT-O). TVT, TOT and TVT-O are collectively known as mid-urethral sling (MUS) operations.
Mid-urethral sling (MUS) operations can be performed as minimal invasive surgery in local anesthesia with short operative time and minimal surgical dissection. This type of surgery is now considered to be the standard surgical management for both SUI and mixed urinary incontinence (MUI) in which there is a predominant stress component. The short- and long term results are comparable to the Burch colposuspension and have been well documented.
Surgical treatment of SUI and MUI is generally recommended after the completion of childbearing for several reasons, one reason being that numerous studies have demonstrated pregnancy and delivery to be risk factors for SUI. Furthermore, in women treated with MUS, a new pregnancy and delivery might, in theory, change the position of the tape leading to the recurrence of incontinence symptoms. Women treated with MUS, who have recurrence of their SUI and MUI, also have a poorer outcome if given a second procedure (either a MUS or a bulking agent).
There is very limited knowledge about the consequences of a pregnancy in women who have undergone a mid-urethral sling operation, and only a few case reports exist in the literature. There is currently no consensus on either the management of a subsequent pregnancy or the mode of delivery after MUS surgery. Some clinical experts have claimed that vaginal delivery, where the baby's head exerts pressure on the anterior vaginal wall, may cause the tape to dislocate with potential injury to the bladder and urethra15. During the last decade, there has been a marked increase in the number of mid-urethral sling operations. This increase is probably due to the excellent short and long-term results, with less morbidity and a shorter hospital stay compared to colposuspension (the previous "gold standard" for SUI). It may therefore be expected in the future that more women of fertile age will request surgical treatment of SUI before the completion of their childbearing.
Several observational studies have shown that SUI is more prevalent in patients who have delivered at least one child. Obstetrical factors such as vaginal birth vs. elective cesarean section, parity, age at first pregnancy/birth and operative vaginal delivery have been associated with an increased risk of developing SUI. In addition, anal incontinence in fertile women is associated with SUI, probably due to more risk of pudendal nerve damage after an obstetrical anal sphincter injury with subsequent anal incontinence. Although obstetric factors are associated with the development of SUI, there are no studies on whether the same factors may negatively impact the outcome after SUI surgery.
The Norwegian Female Incontinence Registry (NFIR) was established in 1998. The purpose of the registry is to ensure the quality of incontinence surgery in Norway and that each department should be able to keep track of their results and use the information to improve the quality of their surgery. The majority of gynecological departments in Norway performing incontinence surgery report preoperative subjective and objective data, the type of incontinence procedures and complications, as well as 6-12 months' subjective and objective follow-up data to the registry. There are currently about 20 000 patients recorded in the registry, in a deidentified form, which means that only the Department that performed the operation has access to patient identity through a coded patient ID number (NFIR-number). Approximately 5 000 of these women are registered as being of childbearing age (< 45 years old) at the time of operation. In 2013 the NFIR obtained status as a National Quality Registry.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Women having undergone at least one pregnancy/delivery after their MUS surgery |
| Controls | – | –Every case will be matched with two controls. The controls will be matched with the study cases' age and year of surgery (+- 2 years of age if a perfect match is not obtainable). These controls have not undergone a subsequent pregnancy/delivery. |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women included in the Norwegian Female Incontinence Registry.
Key inclusion criteria (2 listed)
- Cases, consisting of women identified by the coupling of The Norwegian female incontinence registry and The medical birth registry of Norway as having undergone at least one pregnancy/delivery after their MUS surgery
- Controls, consisting of randomly selected women from Ullevål Hospital registered in the The Norwegian female incontinence registry with MUS surgery. Every case will be matched with two controls. The women will be matched with the study cases' age and year of surgery (+- 2 years of age if a perfect match is not obtainable). These controls have not undergone a subsequent pregnancy/delivery.
Key exclusion criteria (1 listed)
- The only exclusion criterion will be the inability to give consent either due to reduced mental capacity or the lack of language skills in Norwegian or English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective stress incontinence rates
Time frame: Up to ten years
Defined as the percentage of women having a stress incontinence index score < 5 on the validated questionnaire compared to women of equal age and follow-up time (also having undergone MUS surgery) not having undergone a subsequent delivery (controls)
Treatment satisfaction rate
Time frame: Up to ten years
Defined as the percentage of women stating "very satisfied" on the validated questionnaire in both cases and Controls.
The percentage of women not using urinary incontinence pads
Time frame: Up to ten years
Any potential differences in subjective stress continence rates, the rate of women not using pads and treatment satisfaction rates based on the mode of delivery (spontaneous vaginal, operative vaginal and cesarean section)
Time frame: Up to ten years
7 secondary outcomes
Any potential adverse effects of undergoing a subsequent delivery after previous MUS surgery
Time frame: Up to ten years
The continence status during pregnancy (before delivery) and whether any subjective incontinence was persistent or transient after delivery
Time frame: Up to ten years
The effect of time from MUS to subsequent delivery on stress continence status
Time frame: Up to ten years
The impact on stress continence status from having undergone more than one subsequent delivery after MUS
Time frame: Up to ten years
Differences in urgency score between controls and cases
Time frame: Up to ten years
Any differences in subjective stress continence rates, treatment satisfaction rates or the rate of women not using pads when having undergone a subsequent delivery after previous MUS surgery based on the specific type of MUS (TVT, TOT or TVT-O)
Time frame: Up to ten years
The effect of breastfeeding on subjective urinary stress continence rates having undergone pregnancy/delivery after MUS
Time frame: Up to ten 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 15 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Urinary Stress Incontinence, run by Oslo University Hospital 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 1 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 15 Feb 2019. 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?
Subjective stress incontinence rates (time frame: Up to ten years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2019.