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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Norway

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 groups in NCT02999347
Study groupRoleWhat they receive
CasesWomen having undergone at least one pregnancy/delivery after their MUS surgery
ControlsEvery 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.

  1. 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

  2. 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

  3. The percentage of women not using urinary incontinence pads

    Measured: Up to ten years

  4. 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)
  1. Any potential adverse effects of undergoing a subsequent delivery after previous MUS surgery

    Measured: Up to ten years

  2. 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

  3. The effect of time from MUS to subsequent delivery on stress continence status

    Measured: Up to ten years

  4. The impact on stress continence status from having undergone more than one subsequent delivery after MUS

    Measured: Up to ten years

  5. Differences in urgency score between controls and cases

    Measured: Up to ten years

  6. 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

  7. 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.

  1. First posted21 Dec 2016 (estimated)
  2. Study startAug 2014
  3. Primary completionApr 2018
  4. Study completionAug 2018

Resources

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)
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

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.

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