Background: Pelvic organ prolapse (POP) is one of the most common pathologies of the pelvic floor, and it can be found among 40-60% of women who have given birth. Correction of the defect of the DeLancey level II without reconstruction of the apical defect is doomed to failure. Also, in the structure of pelvic floor defects, there is often an incompetency of the perineal body, as a consequence of traumatic delivery. Perineoplasty is considered to be the main method of correction for perineal body incompetency. However, it is worth mentioning that there are no randomized trials, which estimate the influence of simultaneous correction of the perineal body on the effectiveness of transvaginal apical fixation.
Methods: It is planned to include 310 patients in this trial. Patients who met the inclusion/exclusion criteria will be randomized into 2 groups: 1st group-patients who will undergo mesh-augmented sacrospinal fixation with anterior and posterior colporrhaphy without perineoplasty, 2nd group-patients who will undergo mesh-augmented sacrospinal fixation with anterior and posterior colporrhaphy and perineoplasty. Patients will be called to an appointment 6, 12, and 24 months after discharge.
Discussion: The aim of this trial is to evaluate the efficiency and safety of simultaneous perineoplasty on the clinical and anatomical efficacy of mesh-augmented sacrospinal fixation in advanced pelvic organ prolapse repair. Based on previous studies, it was difficult to estimate and comprehend whether colpoperinoplasty actually reduces the risk of prolapse recurrence.
Trial Registration: NCT05422209. Registered on 18 May 2022.
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http://dx.doi.org/10.1186/s13063-024-08448-4 | DOI Listing |
Trials
October 2024
Saint-Petersburg State University Hospital (SPSU Hospital), 154 Fontanka Embankment, Saint-Petersburg, 190103, Russian Federation.
Int Urogynecol J
March 2024
Department of Obstetrics and Gynecology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Int Urogynecol J
October 2023
Department of Urology, Atrium Health Wake Forest Baptist, Winston Salem, NC, 27157, USA.
Introduction And Hypothesis: Anterior sacrospinous hysteropexy (SSH) was popularized by transvaginal mesh kits. Following mesh-kit market withdrawal, we hypothesized similar efficacy through native-tissue reattachment of the pubocervical fascia with fixation of the anterior cervix to the sacrospinous ligament. Few analyses for anterior native-tissue versus mesh-augmented SSH exist.
View Article and Find Full Text PDFInt Urogynecol J
November 2022
Department of Urology and Urological Surgery, University Medical Center Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Introduction And Hypothesis: The objective was to investigate the symptom prevalence of anorectal dysfunction (AD) in women with pelvic organ prolapse (POP) and whether symptom improvement can be achieved by pelvic floor surgery.
Methods: Secondary analysis of the Propel Study data from 277 women with POP stage II-IV regarding bothersome AD symptoms, which were assessed using the Pelvic Floor Distress Inventory (PFDI) questionnaire preoperatively, and 6, 12, and 24 months after transvaginal prolapse repair with Elevate anterior and posterior.
Results: Prevalence of AD was high in the study cohort (14.
Int Urogynecol J
October 2021
Department of Urology and Urological Surgery, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Introduction And Hypothesis: The objective was to investigate the prevalence for voiding dysfunction and if symptom improvement can be achieved by adequate pelvic floor surgery.
Methods: We evaluated the Propel Study data from 281 women with pelvic organ prolapse (POP) stage 2-4. Bother caused by obstructive micturition, voiding dysfunction, and coexisting pelvic floor symptoms were assessed using the Pelvic Floor Distress Inventory (PFDI) preoperatively and 6, 12, and 24 months after vaginal prolapse repair.
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