Observational studyPloS one2014
The safety and acceptance of the PrePex device for non-surgical adult male circumcision in Rakai, Uganda. A non-randomized observational study.
Observational study in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.
- Systematic review: Safety of surgical male circumcision in context of HIV prevention public health programmes.Gates open research · 2022Pooled it
- Reducing Provider Workload While Preserving Patient Safety: A Randomized Control Trial Using 2-Way Texting for Postoperative Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program.Journal of acquired immune deficiency syndromes (1999) · 2020Trial
- Trial
- Circumcision with "no-flip Shang Ring" and "Dorsal Slit" methods for adult males: a single-centered, prospective, clinical study.Asian journal of andrologyTrial
- Article
- Phimosis in Adults: Narrative Review of the New Available Devices and the Standard Treatments.Clinics and practice · 2024Review
- Implementing quality management strategies improves clinical quality as a voluntary medical male circumcision program in Namibia matures: a process analysis.BMC health services research · 2023Article
- Comparison of ring instruments and classic circumcision methods: a systematic review and meta-analysis.Arab journal of urology · 2022Review
- Article
- VMMC clients' perception of increased risk of HIV infection, circumcision preferred choice of method, providers' socio-demographics and mode of service delivery.African health sciences · 2020Article
- Enhancers and barriers to uptake of male circumcision services in Northern Uganda: a qualitative study.AIDS care · 2020Article
- Article
- Timing of adverse events among voluntary medical male circumcision clients: Implications from routine service delivery in Zimbabwe.PloS one · 2018Article
- Implementing voluntary medical male circumcision using an innovative, integrated, health systems approach: experiences from 21 districts in Zimbabwe.Global health action · 2018Article
- Article
- Adverse event profile of a mature voluntary medical male circumcision programme performing PrePex and surgical procedures in Zimbabwe.Journal of the International AIDS Society · 2017Article
- A prospective cohort study of safety and patient satisfaction of voluntary medical male circumcision in Botswana.PloS one · 2017Article
- Safety and efficacy of the PrePex device in HIV-positive men: A single-arm study in Zimbabwe.PloS one · 2017Article
- Trends in the Marginal Cost of Male Circumcision in Rural Rakai Uganda.Journal of acquired immune deficiency syndromes (1999) · 2016Article
- Ockham's Razor and the PrePex Male Circumcision Device.The Journal of infectious diseases · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 4 institutions in 3 countries.
Funding
Abstract
objectivesTo assess the safety and acceptance of the PrePex device for medical male circumcision (MMC) in rural Uganda.
methodsIn an observational study, HIV-uninfected, uncircumcised men aged 18 and older who requested elective MMC were informed about the PrePex and dorsal slit methods and offered a free choice of their preferred procedure. 100 men received PrePex to assess preliminary safety (aim 1). An additional 329 men, 250 chose PrePex and 79 chose Dorsal slit, were enrolled following approval by the Safety Monitoring Committee (aim 2). Men were followed up at 7 days to assess adverse events (AEs) and to remove the PrePex device. Wound healing was assessed at 4 weeks, with subsequent weekly follow up until completed healing.
resultsThe PrePex device was contraindicated in 5.7% of men due to a tight prepuce or phimosis/adhesions. Among 429 enrolled men 350 (82.0%) got the PrePex device and 79 (18.0%) the dorsal slit procedure. 250 of 329 men (76.0%) who were invited to choose between the 2 procedures chose Prepex. There were 9 AEs (2.6%) with the PrePex, of which 5 (1.4%) were severe complications, 4 due to patient self-removal of the device leading to edema and urinary obstruction requiring emergency surgical circumcision, and one due to wound dehiscence following device removal. 71.8% of men reported an unpleasant odor prior to PrePex removal. Cumulative rates of completed wound healing with the PrePex were 56.7% at week 4, 84.8% week 5, 97.6% week 6 and 98.6% week 7, compared to 98.7% at week 4 with dorsal slit (p<0.0001).
conclusionThe PrePex device was well accepted, but healing was slower than with dorsal slit surgery. Severe complications, primarily following PrePex self-removal, required rapid access to emergency surgical facilities. The need to return for removal and delayed healing may increase Program cost and client burden.
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Registered trials
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