Dataset Information

Previous obstetrical history does not impact short-term mid-urethral sling outcomes.

ABSTRACT:

Introduction and hypothesis

Pregnancy and delivery are known risk factors for stress and mixed urinary incontinence. The most common surgical treatment is mid-urethral sling (MUS) surgery. This study evaluated the potential impact of the obstetrical history on the short-term subjective and objective failure rates after MUS surgery.

Methods

A registry-based surgical cohort study using data from the Medical Birth Registry of Norway (MBRN) and the national Norwegian Female Incontinence Registry (NFIR). Data from 14,787 women that underwent MUS surgery from 1998 to 2016 with complete registrations in the MBRN were included. Outcomes were 6-12-month postoperative subjective and objective failure rates. The potential impact of obstetrical and constitutional factors on both outcomes was tested in a multivariate logistic regression model.

Results

Several obstetrical variables seemed to impact both outcomes in the univariate analyses. However, in the multivariate analyses, none of the obstetrical variables significantly impacted subjective failure, and only being nulliparous before MUS surgery remained a risk factor for objective failure [aOR 1.60, (95% CI 1.07-2.40), p = 0.022]. High body mass index at time of surgery, non-retropubic slings, high preoperative urgency symptom load, and surgical complications were all strong risk factors for poor outcomes in the multivariate analyses.

Conclusion

Although childbirth is considered a risk factor for developing stress urinary incontinence, childbirth does not appear to affect the result of MUS in parous women. Our results suggest that nulliparous women with SUI may have a different pathophysiology than SUI after childbirth.

SUBMITTER: Dyrkorn OA

PROVIDER: S-EPMC8295164 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach.PurposeTo present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation.MethodsThe challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network.ResultsThe ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization.LimitationsGiven the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability.ConclusionFindings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible with regards to data collection and be constantly aware of unanticipated opportunities for unmasking. Future surgical trials should be aware of potential challenges in maintaining masking and collection of cost-related information.