Assessing the value of the BSUG database for understanding variations in outcomes of surgery for Stress Urinary Incontinence.

Bach, Fiona Louise ORCID: 0000-0001-8688-9127 (2023). Assessing the value of the BSUG database for understanding variations in outcomes of surgery for Stress Urinary Incontinence. University of Birmingham. M.D.

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Abstract

Introduction: Stress urinary incontinence (SUI) is a common, bothersome condition in women, that can be treated by retropubic mesh tapes (RPT), periurethral bulking agents (PUB), autologous fascial sling (AFS) or colposuspension. The British Society of Urogynaecology (BSUG) hosts a surgical database where members record patient and surgical characteristics, outcomes, and complications related to SUI surgery. Data within the database has the potential to demonstrate real life outcomes of surgery, including patient reported outcomes and complications, and to explore the relationship of different characteristics on outcomes to help informed consent and decision making. Variable clinician engagement means the database needs review for ongoing utility.

Methods: A pilot study was undertaken to determine outcomes and complication rates of RPT (n=18763) and PUB (n=1386) and how these varied with the characteristics recorded on the BSUG database: age, BMI, pelvic floor muscle training (PFMT), urodynamic diagnosis (UDS) and grade of operator as isolated variables. Outcomes studied were patient reported global impression or improvement (PGII), cured/improved SUI, new overactive bladder symptoms (OAB), return to hospital and bladder injury. Following the government enforced pause in vaginal mesh products, the analysis was expanded to include an updated dataset, of RPT (n=24923), PUB (n=4740), AFS (n=538) and colposuspension (n=1700), from 2008 to 2019.

Multivariable logistic regression was used to compare outcomes between the 4 procedures and a second multivariable model used to assess the effect of the patient characteristics above on outcomes for each procedure. Missing data was variable but significant (3-45%) for some common variables and multiple imputation was employed in the multivariable analysis to address this. A BSUG and International Urogynaecology (IUGA) questionnaire assessed clinician views on the database.

Results: RPT, AFS and colposuspension have high success rates for PGII (91%, 89%, 87%) and SUI (all 96.7%) with PUB having significantly lower odds of positive PGII (56.5%) (OR 0.13; 95% CI: 0.09,0.17; p<0.001) and cure/improvement of SUI (74.1%) (OR 0.10; 95% CI: 0.06,0.14 ; p<0.001) compared to RPT. PUB benefit from significantly lower odds of new OAB symptoms developing (OR 0.20; 95% CI: 0.05, 0.84; p=.028) and significantly lower odds of return to hospital for PUB (OR 0.32; 95% CI: 0.19,0.53; p<0.001) compared to RPT. AFS have higher odds of return to hospital (OR 2.42; 95% CI: 1.07,5,45; p=0.033) compared to RPT.
Bladder perforation rate was 3.6% for RPT, 3.4% for AFS and 3.3% for colposuspension and significantly lower in PUB at 0.1% (OR 0.03; 95% CI: 0.00,0.19; p<0.001). Bladder perforation rates following RPT varied across centres due to higher rates with non-consultant grade surgeons (OR 3.88; 95% CI: 2.99, 5.05; p <0.001).
The odds of a positive PGII for RPT, decreased with increased age (OR 0.83; 95% CI: 0.77,0.90; p<0.001), increased BMI (OR 0.95; 95% CI: 0.93,0.97; p<0.001), preoperative urodynamic diagnosis that included overactivity (OR 0.51; 95% CI: 0.41,0.64; p<0.001) and intra-operative bladder injury (OR 0.57; 95% CI: 0.37,0.89; P=0.012).

Discussion: Success and complication rates found, provide real life data which can assist with counselling. Data on return to hospital is minimally reported in the literature. Significant weaknesses with the BSUG database were identified in design, data input and validation and generalisability thus limiting its future use. It remains a useful tool for individual audit and national reports for clinicians that enter data. Further development with input from all stakeholders, including patients, could facilitate wider use in clinical practice and a resource for future research including prognostic data.

Type of Work:

Thesis (Doctorates > M.D.)

Award Type:

Doctorates > M.D.

Supervisor(s):