<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02999347</url>
  </required_header>
  <id_info>
    <org_study_id>2015/434REK</org_study_id>
    <nct_id>NCT02999347</nct_id>
  </id_info>
  <brief_title>Pregnancy After Tension-free Vaginal Tape and Other Mid-urethral Sling Procedures</brief_title>
  <acronym>PregnanT</acronym>
  <official_title>The PregnanT-study: Pregnancy Outcomes After TVT and Other Mid-urethral Sling (MUS) Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the interactions between pregnancy and urinary&#xD;
      stress incontinence in women with a mid-urethral sling (MUS). The specific aims of the 2 sub&#xD;
      studies are:&#xD;
&#xD;
      Study 1:&#xD;
&#xD;
      The main aims of Study 1 are to evaluate any potential impact on urinary stress continence&#xD;
      after a pregnancy/delivery following MUS surgery, and to evaluate any potential differences&#xD;
      in continence status based on the mode of delivery for these women.&#xD;
&#xD;
      Study 2:&#xD;
&#xD;
      The aim of Study 2 is to examine how obstetric factors may affect the degree of incontinence&#xD;
      in women registered in The Norwegian female incontinence registry prior to surgical&#xD;
      treatment. In addition, we want to explore if there are obstetric risk factors predicting&#xD;
      failure of a MUS surgery performed after pregnancy/delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stress urinary incontinence (SUI) is defined as involuntary leakage of urine on effort, or&#xD;
      exertion, or on sneezing or coughing or laughing. This is the commonest form of incontinence&#xD;
      in women affecting one in three over the age of 18 years with significant impact on their&#xD;
      quality of life.&#xD;
&#xD;
      The Tension-free vaginal tape (TVT) was introduced in 1996 and has become one of the most&#xD;
      widely used incontinence operations worldwide. In 2001, Delorme described a new mid-urethral&#xD;
      sling using an outside-in transobturator approach, where the tape is inserted through the&#xD;
      skin and the obturator foramen into the vagina (TOT). DeLeval developed a similar approach in&#xD;
      2003, where the tape is inserted inside-out from the vagina through the obturator foramen and&#xD;
      the skin (TVT-O). TVT, TOT and TVT-O are collectively known as mid-urethral sling (MUS)&#xD;
      operations.&#xD;
&#xD;
      Mid-urethral sling (MUS) operations can be performed as minimal invasive surgery in local&#xD;
      anesthesia with short operative time and minimal surgical dissection. This type of surgery is&#xD;
      now considered to be the standard surgical management for both SUI and mixed urinary&#xD;
      incontinence (MUI) in which there is a predominant stress component. The short- and long term&#xD;
      results are comparable to the Burch colposuspension and have been well documented.&#xD;
&#xD;
      Surgical treatment of SUI and MUI is generally recommended after the completion of&#xD;
      childbearing for several reasons, one reason being that numerous studies have demonstrated&#xD;
      pregnancy and delivery to be risk factors for SUI. Furthermore, in women treated with MUS, a&#xD;
      new pregnancy and delivery might, in theory, change the position of the tape leading to the&#xD;
      recurrence of incontinence symptoms. Women treated with MUS, who have recurrence of their SUI&#xD;
      and MUI, also have a poorer outcome if given a second procedure (either a MUS or a bulking&#xD;
      agent).&#xD;
&#xD;
      There is very limited knowledge about the consequences of a pregnancy in women who have&#xD;
      undergone a mid-urethral sling operation, and only a few case reports exist in the&#xD;
      literature. There is currently no consensus on either the management of a subsequent&#xD;
      pregnancy or the mode of delivery after MUS surgery. Some clinical experts have claimed that&#xD;
      vaginal delivery, where the baby's head exerts pressure on the anterior vaginal wall, may&#xD;
      cause the tape to dislocate with potential injury to the bladder and urethra15. During the&#xD;
      last decade, there has been a marked increase in the number of mid-urethral sling operations.&#xD;
      This increase is probably due to the excellent short and long-term results, with less&#xD;
      morbidity and a shorter hospital stay compared to colposuspension (the previous &quot;gold&#xD;
      standard&quot; for SUI). It may therefore be expected in the future that more women of fertile age&#xD;
      will request surgical treatment of SUI before the completion of their childbearing.&#xD;
&#xD;
      Several observational studies have shown that SUI is more prevalent in patients who have&#xD;
      delivered at least one child. Obstetrical factors such as vaginal birth vs. elective cesarean&#xD;
      section, parity, age at first pregnancy/birth and operative vaginal delivery have been&#xD;
      associated with an increased risk of developing SUI. In addition, anal incontinence in&#xD;
      fertile women is associated with SUI, probably due to more risk of pudendal nerve damage&#xD;
      after an obstetrical anal sphincter injury with subsequent anal incontinence. Although&#xD;
      obstetric factors are associated with the development of SUI, there are no studies on whether&#xD;
      the same factors may negatively impact the outcome after SUI surgery.&#xD;
&#xD;
      The Norwegian Female Incontinence Registry (NFIR) was established in 1998. The purpose of the&#xD;
      registry is to ensure the quality of incontinence surgery in Norway and that each department&#xD;
      should be able to keep track of their results and use the information to improve the quality&#xD;
      of their surgery. The majority of gynecological departments in Norway performing incontinence&#xD;
      surgery report preoperative subjective and objective data, the type of incontinence&#xD;
      procedures and complications, as well as 6-12 months' subjective and objective follow-up data&#xD;
      to the registry. There are currently about 20 000 patients recorded in the registry, in a&#xD;
      deidentified form, which means that only the Department that performed the operation has&#xD;
      access to patient identity through a coded patient ID number (NFIR-number). Approximately 5&#xD;
      000 of these women are registered as being of childbearing age (&lt; 45 years old) at the time&#xD;
      of operation. In 2013 the NFIR obtained status as a National Quality Registry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective stress incontinence rates</measure>
    <time_frame>Up to ten years</time_frame>
    <description>Defined as the percentage of women having a stress incontinence index score &lt; 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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment satisfaction rate</measure>
    <time_frame>Up to ten years</time_frame>
    <description>Defined as the percentage of women stating &quot;very satisfied&quot; on the validated questionnaire in both cases and Controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The percentage of women not using urinary incontinence pads</measure>
    <time_frame>Up to ten years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>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)</measure>
    <time_frame>Up to ten years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Any potential adverse effects of undergoing a subsequent delivery after previous MUS surgery</measure>
    <time_frame>Up to ten years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The continence status during pregnancy (before delivery) and whether any subjective incontinence was persistent or transient after delivery</measure>
    <time_frame>Up to ten years</time_frame>
    <description>Assesed on a validated questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of time from MUS to subsequent delivery on stress continence status</measure>
    <time_frame>Up to ten years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The impact on stress continence status from having undergone more than one subsequent delivery after MUS</measure>
    <time_frame>Up to ten years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in urgency score between controls and cases</measure>
    <time_frame>Up to ten years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>Up to ten years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of breastfeeding on subjective urinary stress continence rates having undergone pregnancy/delivery after MUS</measure>
    <time_frame>Up to ten years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Urinary Incontinence</condition>
  <condition>Urinary Stress Incontinence</condition>
  <condition>Pregnancy Complications</condition>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
    <description>Women having undergone at least one pregnancy/delivery after their MUS surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women included in the Norwegian Female Incontinence Registry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cases, consisting of women identified by the coupling of The Norwegian female&#xD;
             incontinence registry and The medical birth registry of Norway as having undergone at&#xD;
             least one pregnancy/delivery after their MUS surgery&#xD;
&#xD;
          -  Controls, consisting of randomly selected women from Ullevål Hospital registered in&#xD;
             the The Norwegian female incontinence registry with MUS surgery. Every case will be&#xD;
             matched with two controls. The women will be matched with the study cases' age and&#xD;
             year of surgery (+- 2 years of age if a perfect match is not obtainable). These&#xD;
             controls have not undergone a subsequent pregnancy/delivery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The only exclusion criterion will be the inability to give consent either due to&#xD;
             reduced mental capacity or the lack of language skills in Norwegian or English.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gynekologisk avdeling, Oslo Universitetssykehus Ullevål</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Ole Aleksander Jonsbu Dyrkorn</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Treatment Outcome</keyword>
  <keyword>Mid-urethral slings</keyword>
  <keyword>Gynecologic Surgery Procedures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02999347
org study id: 2015/434REK
nct id: NCT02999347
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Retrospective
measure: Subjective stress incontinence rates
time frame: Up to ten years
description: 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)
measure: Treatment satisfaction rate
time frame: Up to ten years
description: Defined as the percentage of women stating "very satisfied" on the validated questionnaire in both cases and Controls.
measure: The percentage of women not using urinary incontinence pads
time frame: Up to ten years
measure: 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
measure: Any potential adverse effects of undergoing a subsequent delivery after previous MUS surgery
time frame: Up to ten years
measure: The continence status during pregnancy (before delivery) and whether any subjective incontinence was persistent or transient after delivery
time frame: Up to ten years
description: Assesed on a validated questionnaire
measure: The effect of time from MUS to subsequent delivery on stress continence status
time frame: Up to ten years
measure: The impact on stress continence status from having undergone more than one subsequent delivery after MUS
time frame: Up to ten years
measure: Differences in urgency score between controls and cases
time frame: Up to ten years
measure: 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
measure: The effect of breastfeeding on subjective urinary stress continence rates having undergone pregnancy/delivery after MUS
time frame: Up to ten years
arm group label: Cases
description: Women having undergone at least one pregnancy/delivery after their MUS surgery
arm group label: Controls
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Ole Aleksander Jonsbu Dyrkorn
investigator title: MD
mesh term: Urinary Incontinence
mesh term: Pregnancy Complications
mesh term: Urinary Incontinence, Stress
sharing ipd: Undecided