ArticlePloS one2014
Safety, effectiveness and acceptability of the PrePex device for adult male circumcision in Kenya.
Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01711411 (Prospective Observational Study of Male Circumcision Using the PrePex Device in Routine Clinical Settings in Kenya), which is not on this map. Cited by 35 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.
Prospective Observational Study of Male Circumcision Using the PrePex Device in Routine Clinical Settings in Kenya
Who cites it
35 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions.The Cochrane database of systematic reviews · 2021Pooled 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
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- Improving patient satisfaction and anatomical fit: a retrospective study on the purse-string suture-assisted disposable circumcision suture device.Translational andrology and urology · 2025Article
- Knowledge and Attitudes of Circumcision among Adult Male Clients Receiving Care in a Teaching Hospital in Kigali City, Rwanda.Rwanda journal of medicine and health sciences · 2024Article
- Comments by opponents on the British Medical Association's guidance on non-therapeutic male circumcision of children seem one-sided and may undermine public health.World journal of clinical pediatrics · 2023Article
- 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
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- 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
- Long term post PrePex male circumcision outcomes in an urban population in Uganda: a cohort study.BMC research notes · 2017Article
- Circumcision and its effects in Africa.Translational andrology and urology · 2017Review
- 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 systems-based assessment of the PrePex device adverse events active surveillance system in Zimbabwe.PloS one · 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
- Factors Associated With Delayed Healing in a Study of the PrePex Device for Adult Male Circumcision in Kenya.Journal of acquired immune deficiency syndromes (1999) · 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
9 authors.
Funding
Abstract
objectiveTo assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC) in routine service delivery in Kenya.
methodsWe enrolled 427 men ages 18-49 at one fixed and two outreach clinics. Procedures were performed by trained clinical officers and nurses. The first 50 enrollees were scheduled for six follow-up visits, and remaining men were followed at Days 7 and 42. We recorded adverse events (AEs) and time to complete healing, and interviewed men about acceptability and pain.
resultsPlacement and removal procedures each averaged between 3 and 4 minutes. Self-reported pain was minimal during placement but was fleetingly intense during removal. The rate of moderate/severe AEs was 5.9% overall (95% confidence interval [CI] 3.8%-8.5%), all of which resolved without sequelae. AEs included 5 device displacements, 2 spontaneous foreskin detachments, and 9 cases of insufficient foreskin removal. Surgical completion of MMC was required for 9 men (2.1%). Among the closely monitored first 50 participants, the probability of complete healing by Day 42 was 0.44 (95% CI 0.30-0.58), and 0.90 by Day 56. A large majority of men was favorable about their MMC procedure and would recommend PrePex to friends and family.
conclusionsThe PrePex device was effective for MMC in Kenya, and well-accepted. The AE rate was higher than reported for surgical procedures there, or in previous PrePex studies. Healing time is longer than following surgical circumcision. Provider experience and clearer counseling on post-placement and post-removal care should lead to lower AE rates.
trial registrationClinicalTrials.gov NCT01711411.
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