Pregnancy After Tension-free Vaginal Tape and Other Mid-urethral Sling Procedures

NCT02999347 | Completed

• 1 other identifier: 2015/434REK
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Urinary Incontinence; Urinary Stress Incontinence; Pregnancy Complications

Keywords

Treatment Outcome; Mid-urethral slings; Gynecologic Surgery Procedures

Outcome Measures

Primary Outcomes (4)

• 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)

  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.

  Up to ten years

• The percentage of women not using urinary incontinence pads

  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)

  Up to ten years

Secondary Outcomes (7)

• Any potential adverse effects of undergoing a subsequent delivery after previous MUS surgery

  Up to ten years

• The continence status during pregnancy (before delivery) and whether any subjective incontinence was persistent or transient after delivery

  Up to ten years

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

  Up to ten years

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

  Up to ten years

• Differences in urgency score between controls and cases

  Up to ten years

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women included in the Norwegian Female Incontinence Registry.

You may qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Gynekologisk avdeling, Oslo Universitetssykehus Ullevål

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress; Pregnancy Complications

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 21, 2016
• Study Start: August 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

NO (1)