Evidence map›Paper›PMID 28191790›Full record

ArticleInternational braz j urol : official journal of the Brazilian Society of Urology

Safety and short term outcomes of a new truly minimallyinvasive mesh-less and dissection-less anchoring system for pelvic organ prolapse apical repair.

Adi Y Weintraub, Masha Ben Zvi, David Yohay, Joerg Neymeyer, Yonatan Reuven, Menahem Neuman, Alex Tsivian

Abstract read
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Article in International braz j urol : official journal of the Brazilian Society of Urology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Adi Y WeintraubDepartment of Obstetrics and Gynecology, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheba, Israel.
Masha Ben ZviDepartment of Urologic Surgery, Edith Wolfson Medical Center, Holon, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
David YohayDepartment of Obstetrics and Gynecology, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheba, Israel.
Joerg NeymeyerDepartment of Urology, Charitè University, Berlin, Germany.
Yonatan ReuvenSiaal Research Center for Family Medicine and Primary Care, Division of Community Health, Faculty of Health Science, Ben-Gurion University of the Negev, Beer Sheva, Israel.
Menahem NeumanUrogynecology, Department of Obstetrics and Gynecology, Galilee Hospital, and the Faculty of Medicine in the Galilee, Bar Ilan University, Safed, Israel.
Alex TsivianDepartment of Urologic Surgery, Edith Wolfson Medical Center, Holon, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the safety and short term outcomes of a new, truly minimallyinvasive, mesh-less and dissection-less anchoring system for pelvic floor apical repair.

methodsA prospective study was conducted using the NeuGuide™ device system for pelvic floor apical repair. The primary effectiveness outcome was centro-apical pelvic floor prolapse by POP-Q after six months. The primary safety outcome was intra-operative, immediate (first 48 h) post-operative complications and adverse effects after six months. A standardized questionnaire (UDI-6) to assess quality of life at entry and during follow-up visits was used. Patients' six months-follow-up and evaluation are reported.

resultsThe mean age of the study population (n=10) was 63.8±12.0 years. All patients had a previous prolapse surgery. Five had a previous hysterectomy and two had stress urinary incontinence symptoms. During surgery six patients had a concurrent colporrhaphy. There was no injury to the bladder, rectum, pudendal nerves, or major pelvic vessels and no febrile morbidity was recorded. At six months, no cases of centro-apical recurrence were noted. Patients were satisfied with the procedure and had favorable quality of life scores. Using the UDI-6 questionnaire an improvement, in all domains was seen. Moreover, although the sample size was small, the improvement in urge and overflow incontinence related domains were demonstrated to be statistically significant.

conclusionsThis new NeuGuide™ device allows rapid and safe introduction of a suspending suture through the sacrospinous ligament and makes sacrospinous ligament fixation easy to perform, while avoiding dissection and mesh complications.

Indexed as

AgedFemaleHumansMinimally Invasive Surgical ProceduresPelvic Organ ProlapsePostoperative ComplicationsProspective StudiesQuality of LifeSurveys and QuestionnairesTreatment OutcomeMinimally Invasive Surgical ProceduresPelvic Floor DisordersProlapse

Identifiers

PMID28191790
PMCPMC5462146

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.