Table 1 Study measurements and timing of data capture for longitudinal cohort

Outcome variables

 Fistula repair breakdown or recurrence (Obj 1)

Reopening of the fistula following repair, prior to complete healing, or de novo fistula occurrence. Confirmed by positive methylene blue dye test or other method

MR

●

●

●

●

●

 Post-repair urinary incontinence (Obj 2)

Urinary incontinence with confirmed fistula closure

MR

●

●

●

●

●

Predictor Variables

Patient-related: study participant characteristics, potentially important biological and social risk factors for poor health

 Socio-demographics

Age, educational attainment

PQ

●

Income, assets, food security [42]

PQ

●

●

 Obstetric history

Parity, pregnancy outcomes (pre-fistula, during-fistula), time since fistula development

PQ, MR

●

 Health status

Nutritional status^b

MR

●

●

●

●

●

Co-morbidities,^c urinary tract infection, functional health,^d

PQ, MR

●

●

●

●

●

Fistula-related: selected characteristics illustrate fistula severity and physical burden of fistula

 Fistula characteristics

Size, location, fistula etiology^e, fistula type^f, VVF grade^g, vaginal scarring, bladder capacity, urethral length, bladder neck involvement, other urogyn diagnoses

MR

●

 Fistula history

Time since fistula development, etiology, symptoms^h, number of previous repairs, treatments

PQ, MR

●

Fistula repair-related: measures include provider training, procedural decisions, and complications

 Repair procedure

Surgical routeⁱ; layers, suture type; anesthetic type; sling and tension; flap use, graft use and type, prophylactic antibiotic use, catheterization^j

MR, PS

●

 Quality of care

Person-centered care

PQ

●

 Provider characteristics

Surgeon, surgical level and experience, repair center

PS

●

 Repair complications

Bleeding, infection, leakage, pain (48 h +), catheter blockage, other

MR, PS

●

Post-repair behaviors and exposures: variables capture physical and sexual risks

 Physical activity and trauma

Moderate and vigorous activity, peak and long-term weight lifting^k, physical violence^l

PQ

●

●

●

●

●

 Sexual activity and fertility

Post-surgical resumption of sexual activity, frequency of sexual activity, sexual satisfaction^m, fertility intentions, menstruation, contraceptive use

PQ

●

●

●

●

●

 Lifestyle

Dietary quality, alcoholⁿ, tobacco^o, and caffeine consumption^p; medical and traditional medical care

PQ

●

●

●

●

●

Pregnancy-related factors: pregnancy-related factors below may contribute to risk of adverse outcomes through biological or social mechanisms

 Pregnancy-related health

Chronic and pregnancy-related co-morbidities^q, timing of pregnancy

PQ, MR

●

●

●

●

●

 Antenatal care

ANC initiation, timing, frequency and location, birth planning

PQ, MR

●

●

●

●

●

 Delivery-related

Gestational age at delivery, delivery mode^r, birth attendant, length of labor

PS, MR

●

●

●

●

●

 Delivery complications

Prolonged/obstructed labor, hemorrhage, other

PS, MR

●

●

●

●

●

Other Variables: selected characteristics are important for a broader understanding of women’s recovery from fistula and repair

 Psychosocial health

Reintegration^s, quality of life^t, depression^u, anxiety^v, self-esteem^w, stigma^q, social support^y, and relationship quality^z, PTSD^aa

PQ

●

●

●

●

●

 Sexual function

Sexual function and satisfaction^bb

PQ

●

●

●

●

●

 Adjunct service receipt

Receipt of any psychological, physical, social, or economic services or assistance, and dose

PQ

●

●

●

●

●

 Empowerment

Economic control^cc, patient knowledge

PQ

●

●

●

●

●