Evidence on the effectiveness of the intervention was derived from one systematic review, which therefore provided the evidence base for the recommendation included in this guideline (9). The sub-sections below present the recommendation and associated remarks, followed by the corresponding narrative summary of evidence for the priority/PICO question: For women in the postoperative period after the surgical repair of a simple obstetric urinary fistula (P), is shorter duration of bladder catheterization (10 days or less) (I) as effective as longer duration (more than 10 days) (C), in preventing repair breakdown (O)?
The evidence base is summarized in one GRADE table, which is presented separately in the Web annex to this document.1
Annex 5 presents the evidence-to-decision table, summarizing the quality of the evidence, values and preferences, the balance between benefits and harms, the cost/resource implications, as well as issues of equity, acceptability and feasibility, which were all considered in formulating the recommendation and in determining its strength and direction.
3.1. Recommendation
This guideline includes one recommendation adopted by the Guideline Development Group (GDG). To ensure that the recommendation is correctly understood and appropriately implemented in practice, remarks summarizing the key points of the GDG discussions are presented with the recommendation.
RECOMMENDATION: For women in the postoperative period after the surgical repair of a simple obstetric urinary fistula, short duration of bladder catheterization (7 to 10 days) is recommended as an alternative to longer duration of catheterization
Remarks
The Guideline Development Group (GDG) acknowledges that there are several ways of defining the severity of fistula. For the purposes of this recommendation, the GDG considered “simple” fistula as a mid-anterior vaginal wall fistula with minimal scarring and with a diameter of 3 cm or less.
For fistula cases that are not considered simple, an option different to the one recommended in this guideline may be required.
The GDG acknowledges the variation in the use of bladder catheter after fistula surgery and notes that some surgeons may consider “short” duration of catheterization to be less than 7 days. However, for the purposes of this recommendation, the GDG defines short duration as 7 to 10 days.
This recommendation is applicable to any context where women experience simple obstetric urinary fistula due to obstructed labour.
The GDG accepts the uncertainty in the outcomes for shorter and longer duration of bladder catheterization in light of other benefits, such as improvement in patients’ comfort, potential reduction in the risk of infections associated with catheterization, and decrease in patients’ needs for health services.
While shorter hospitalization associated with shorter postoperative bladder catheterization would increase the availability of fistula care services (so that more patients could potentially be treated), this should be carefully balanced with the quality of services (i.e. the provision of a holistic care package to women who are recovering from obstetric fistula repair).
3.2. Summary of evidence
Description of the studies contributing evidence
Evidence on the duration of bladder catheterization after surgical repair of simple obstetric urinary fistula was derived from the systematic review that was conducted for the purposes of the development of this guideline (
9). The systematic review included two RCTs with a combined sample of 684 women (
6,
7).
The two included trials were conducted in eight African countries (the Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Niger, Nigeria, Sierra Leone and Uganda) and recruited women with a simple urinary fistula that was closed after surgery (with outcome determined by dye test). Both studies were designed to show non-inferiority of two durations of bladder catheterization.
Barone et al., 2015, included women with simple obstetric urinary fistula as determined by the surgeon after repair surgery. Nardos et al., 2012, included women with simple obstetric urinary fistula assessed at physical exam before surgery.
Barone et al. excluded women who were pregnant, any fistula was not simple or was multiple, and any fistula that was radiation induced, associated with cancer, or due to lymphogranuloma venereum. Nardos et al. excluded women with a history of fistula repair, and any current vesicovaginal fistula with circumferential involvement of the urethra.
Both trials compared shorter with longer duration of bladder catheterization postoperatively. The longer duration was the same in both trials (14 days), whereas the shorter time was 10 days in Nardos et al. and 7 days in Barone et al.
Barone et al. reported the primary outcome (fistula repair breakdown after catheter removal) based on dye test results in all participants. Nardos et al. defined cure (the primary outcome) as the absence of leakage after catheter removal and confirmed it with a dye test only in symptomatic women.
Outcomes
Five outcomes are considered “critical” in the context of length of postoperative bladder catheterization. There were no statistically significant differences between shorter versus longer duration of bladder catheterization for four critical outcomes: (i) the risk of fistula repair breakdown before hospital discharge (risk ratio [RR]: 1.14, 95% confidence interval (CI): 0.49–2.64; 1 study, 495 women; low-quality evidence); (ii) the risk of fistula repair breakdown after hospital discharge (RR: 1.64, 95% CI: 0.81–3.31; 1 study, 495 women; moderate-quality evidence); (iii) urinary incontinence after hospital discharge (RR: 1.16, 95% CI: 0.62–2.18; 1 study, 495 women; low-quality evidence); and (iv) extended hospital stay (RR: 9.33, 95% CI: 0.51–172.41; 1 study, 495 women; moderate-quality evidence). The fifth critical outcome – maternal satisfaction with care – was not reported in any of the studies.
The remaining four outcomes are classified as “important” in the context of postoperative bladder catheterization. There were no statistically significant differences between shorter versus longer duration of bladder catheterization for three outcomes: (i) post-repair urinary infection (RR: 5.18, 95% CI: 0.25–107.44; 1 study, 495 women; low-quality evidence); (ii) urinary incontinence during hospital stay (RR: 1.15, 95% CI: 0.54–2.43; 1 study, 189 women; very low-quality evidence); and (iii) urinary retention after catheter removal (RR: 1.34, 95% CI: 0.79–2.27; 2 studies, 684 women; moderate-quality evidence). The fourth important outcome – the cost of care – was not reported in any of the studies.
Additional considerations
Balance of benefits and harms
The evidence base does not indicate any significant differences in adverse clinical outcomes for women after surgery for simple obstetric urinary fistula depending on whether they undergo shorter or longer periods of postoperative bladder catheterization. However, shorter duration of postoperative bladder catheterization is considered to be more convenient for the women as it represents reduced discomfort and lower probability of having complications associated with catheterization.
Quality of evidence
Available evidence is limited to two RCTs, with one contributing the majority of data on outcomes. The overall quality of the evidence was low to moderate for critical outcomes. The main reason for downgrading the quality of the evidence from “high” was imprecision in the effect estimates (rarity of events and wide confidence intervals).
Values and preferences
Women with fistula, irrespective of which country they are from, are likely to place a high value on shorter duration of catheterization. Shorter bladder catheterization represents less discomfort and inconvenience to the women, allowing them to regain personal health and well-being more quickly and resume their lives. Prolonged bladder catheterization equates to extended need for health services (e.g. hospitalization, since outpatient management is not possible for those with catheter needs) and increased risk of pain, infection and erosion related to the catheter. No systematic review was identified and/or conducted for this criterion. The panel is confident that health-care providers and women from different countries and settings value shorter treatment duration similarly highly.
Resources and costs
Neither of the trials included in the systematic review captured the cost of care or other resource implications. However, the implementation of the shorter duration of catheterization is likely to reduce costs and lead to more cost-effective use of health-care resources. Patients treated for a shorter period would have less risk of complications such as nosocomial infections, and may need fewer health-care services (e.g. shorter hospital stays).
Equity
The recommendation is likely to reduce health inequities. Women with shorter duration of catheterization would be able to regain health and well-being and to socially reintegrate more quickly than those who are catheterized for longer periods. Resuming their roles in the family and in the community is of paramount importance for these women, who are often marginalized from their families and communities while living with fistula, such that their quality of life is severely affected.
Acceptability
The short duration of catheterization after the surgical repair of simple obstetric urinary fistula is not associated with adverse clinical outcomes. By implementing the shorter duration of catheterization, health-care managers and providers would be able to offer fistula repair services to more women as the postoperative nursing care would be shorter and patients would be discharged from hospital sooner. For the patients, having the catheter in place for a shorter period would potentially reduce the risk of complications associated with catheterization, and would mean shorter hospital stays and faster social reintegration.
Feasibility
The shorter duration of catheterization post-surgery does not warrant additional care when it is compared to the longer duration. Both methods are considered equally feasible as the catheterization procedures are the same. No additional resources, infrastructure or training are needed.
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