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. 2022 Aug 30;2022(8):CD013608. doi: 10.1002/14651858.CD013608.pub2

Russo 2019.

Study characteristics
Methods Study design
  • Parallel, open‐label RCT


Study duration and follow‐up
  • 4 weeks postop (study dates not reported)


Study type
  • Prevention study (perioperative prophylaxis)

Participants General information
  • Country: Italy

  • Setting: single centre

  • Inclusion criteria: women who were submitted to native tissue repair for cystoceles; postmenopausal women with symptomatic isolated anterior prolapse pelvic organ prolapse stage ≥ III

  • Exclusion criteria: previous pelvic organ prolapse surgery; current UTI; known allergy to cranberry‐containing products; presence of pelvic pain; use of prophylactic antibiotics within 7 days before study entry; none of the patients had LUTS at enrolment and none was a current or past user of general or topical oestrogens or other forms of hormone replacement therapy


Baseline characteristics
  • Number: treatment group (20); control group (20)

  • Mean age ± SD: 67.2 ± 2.3 years

  • Sex: 100% women

  • Relevant health status: nulliparous (2); menopausal (40); reported UTI in past 6 months (2); LUTS (40)

  • Definition of UTI: positive urine culture

  • Co‐morbidities: not reported

  • Differences between groups at baseline: "The two groups were comparable for age, body mass index and grade of prolapse"

Interventions Treatment group
  • Cranberry + D‐mannose + boswellia + curcuma + NoxamicineVR (Kistinox ActVR) oral preparation (doses not reported)

    • One dose twice/day as nutritional supplement for 2 weeks after surgery


Control group
  • No treatment and no nutritional supplements


Co‐interventions or additional treatments
  • "The surgical procedures were performed by the same surgeon at the Pisa University Hospital. Anterior native tissue repair was performed by a plication of the pubo‐cervical fascia in the midline and the vaginal skin was sutured with a delayed absorbable suture. No antibiotic was used peri‐ or postoperatively, according to the local and international guidelines. No vaginal packing or indwelling Foley catheter was used after surgery."


Follow‐up details
  • 4 weeks post‐operative

Outcomes Outcomes reported at 2 and 4 weeks postop
  • Effectiveness in the prevention of postoperative LUTS perception and UTIs

  • Safety and tolerability of the supplement

  • Time to return of normal voiding postoperatively

  • PVR postoperatively (by the spontaneous fill method)

  • Postoperative pain (VAS)


Notes
  • "The validated questionnaire on female lower urinary tract symptoms (ICIQ‐FLUTS) was completed at baseline and week 4. The ICIQ‐FLUTS consists of 24 items, of which 11 items can be assessed into three sub‐scales (filling, voiding, incontinence). The other 11 items are not incorporated in the overall score but indicate impact of symptoms on the quality of life."

Notes  
  • Trial registration: not reported

  • A priori published protocol: Protocol ID12219 for ethics only

  • Funding: "this work was supported by an unrestricted grant from Laborest and by the University of Pisa funds to Tommaso Simoncini, Pisa, Italy"

  • Conflicts of interest: "the authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported. The authors alone are responsible for the content and writing of the paper."


 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "...randomized as per a simple randomization. Determination of whether a patient would be treated or not was made by reference to a statistical series based on random sampling numbers drawn up by Dr Eleonora Russo."
Allocation concealment (selection bias) Unclear risk Comment: no information provided regarding the concealment of allocation to groups
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: open‐label study
Blinding of outcome assessment (detection bias)
All outcomes High risk Comment: open‐label study
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: attrition (0%)
Selective reporting (reporting bias) Unclear risk Trial registration: not reported
A priori published protocol: Protocol ID12219 for ethics only
Other bias High risk Funding: "this work was supported by an unrestricted grant from Laborest and by the University of Pisa funds to Tommaso Simoncini, Pisa, Italy."
Conflicts of interest: "the authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported. The authors alone are responsible for the content and writing of the paper."

CFU: colony forming units; CKD: chronic kidney disease; IQR: interquartile range; LUTS: lower urinary tract symptoms; M/F: male/female; PACs‐A: proanthocyanidins; PVR: post void residual; RCT: randomised controlled trial; SD: standard deviation; UTI: urinary tract infection; VAS: visual analogue scale; WCC: white cell count