Clinical Trials Logo

Clinical 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 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.

Clinical Trial 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

Related Conditions & MeSH terms

NCT number NCT02999347
Study type Observational
Source Oslo University Hospital
Status Completed
Start date August 2014
Completion date August 2018

See also
  Status Clinical Trial Phase
Completed NCT04071301 - Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence N/A
Active, not recruiting NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Not yet recruiting NCT03027986 - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy N/A
Recruiting NCT02490917 - ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence N/A
Enrolling by invitation NCT02529371 - Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients N/A
Enrolling by invitation NCT02530372 - Feasibility of the UriCap-F for Urine Collection in Hospitalized Women N/A
Completed NCT02549729 - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy N/A
Completed NCT02338726 - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study N/A
Completed NCT02600676 - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis N/A
Completed NCT02239796 - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence N/A
Completed NCT02368262 - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy N/A
Completed NCT01942681 - Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride N/A
Recruiting NCT01804153 - Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO) Phase 1/Phase 2
Completed NCT01520948 - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease Phase 3
Completed NCT01479816 - Urinary Continence Index for Prediction of Urinary Incontinence in Older Women N/A
Active, not recruiting NCT01599715 - Translating Unique Learning for Incontinence Prevention Phase 2
Completed NCT02226237 - Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy N/A
Completed NCT01276340 - Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation of Female Urinary Incontinence N/A
Completed NCT01239836 - Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women N/A
Completed NCT01578369 - Effect of Pelvic Floor Muscle Training Included in General Fitness Classes During Pregnacy N/A