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Tension-free polypropylene mesh-related surgical repair for pelvic organ prolapse has a good anatomic success rate but a high risk of complications.

Zhang L, Zhu L, Chen J, Xu T, Lang JH - Chin. Med. J. (2015)

Bottom Line: We observed a 93.8% (45/48) positive anatomical outcome rate at 12 months and 90.0% (27/30) at 24 months.Vaginal complication was the main complication observed (35.4%, 17/48).The mesh complications were not the definitive cause of recurrence.

View Article: PubMed Central - PubMed

Affiliation: Department of Gynecology and Obstetrics, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China.

ABSTRACT

Background: Food and Drug Administration announcements have highlighted the standard rate of mesh-related complications. We aimed to report the short-term results and complications of tension-free polypropylene mesh (PROSIMA™) surgical repair of pelvic organ prolapse (POP) using the standard category (C), timing (T), and site (S) classification system.

Methods: A prospective cohort study of 48 patients who underwent PROSIMA™ mesh kit-related surgical repairs were followed for two years at Peking Union Medical College Hospital. Recurrence was defined as symptomatic POP quantification (POP-Q) Stage II or higher (leading edge ≥ -1 cm). The Patient Global Impression of Change Questionnaire, the Chinese version of the Pelvic Floor Impact Questionnaire short-form-7 and POP/Urinary Incontinence Sexual Questionnaire short-form-12 were used to evaluate the self-perception and sexual function of each patient. Mesh-related complications conformed to the International Urogynecological Association/International Continence Society joint terminology. The paired-sample t-test, one-way analysis of variance, Fisher's exact test, Kaplan-Meier survival analysis and log-rank test were used to analyze data.

Results: All patients were followed up for ≥12 months; 30 (62.5%) patients completed the 24 months study. We observed a 93.8% (45/48) positive anatomical outcome rate at 12 months and 90.0% (27/30) at 24 months. Recurrence most frequently involved the anterior compartment (P < 0.05). Pelvic symptoms improved significantly from baseline (P < 0.05), although the patients' impressions of change and sexual function were not satisfying. Vaginal complication was the main complication observed (35.4%, 17/48). The survival analysis did not identify any relationship between vaginal complication and anatomical recurrent prolapse (POP-Q ≥ Stage II) (P = 0.653).

Conclusions: Tension-free polypropylene mesh (PROSIMA™ )-related surgical repair of POP has better short-term anatomical outcomes at the apical and posterior compartments, but a low patient satisfaction rate. The mesh complications were not the definitive cause of recurrence.

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The Kaplan-Meier survival curve of prolapse-free survival rate and a log-rank test of the complication-free survival rate during the longest follow-up time.
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Figure 1: The Kaplan-Meier survival curve of prolapse-free survival rate and a log-rank test of the complication-free survival rate during the longest follow-up time.

Mentions: We aimed to identify the relationship between vaginal complication (mesh exposure) and the degeneration of POP-Q stage. We found that the anterior compartment was the compartment most often involved with recurrence and vaginal complications. However, the Kaplan-Meier and log-rank survival analyses did not find any significant relationship between anatomical recurrent prolapse (POP-Q Stage ≥ II) and vaginal complications (P = 0.653) [Figure 1].


Tension-free polypropylene mesh-related surgical repair for pelvic organ prolapse has a good anatomic success rate but a high risk of complications.

Zhang L, Zhu L, Chen J, Xu T, Lang JH - Chin. Med. J. (2015)

The Kaplan-Meier survival curve of prolapse-free survival rate and a log-rank test of the complication-free survival rate during the longest follow-up time.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4837857&req=5

Figure 1: The Kaplan-Meier survival curve of prolapse-free survival rate and a log-rank test of the complication-free survival rate during the longest follow-up time.
Mentions: We aimed to identify the relationship between vaginal complication (mesh exposure) and the degeneration of POP-Q stage. We found that the anterior compartment was the compartment most often involved with recurrence and vaginal complications. However, the Kaplan-Meier and log-rank survival analyses did not find any significant relationship between anatomical recurrent prolapse (POP-Q Stage ≥ II) and vaginal complications (P = 0.653) [Figure 1].

Bottom Line: We observed a 93.8% (45/48) positive anatomical outcome rate at 12 months and 90.0% (27/30) at 24 months.Vaginal complication was the main complication observed (35.4%, 17/48).The mesh complications were not the definitive cause of recurrence.

View Article: PubMed Central - PubMed

Affiliation: Department of Gynecology and Obstetrics, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China.

ABSTRACT

Background: Food and Drug Administration announcements have highlighted the standard rate of mesh-related complications. We aimed to report the short-term results and complications of tension-free polypropylene mesh (PROSIMA™) surgical repair of pelvic organ prolapse (POP) using the standard category (C), timing (T), and site (S) classification system.

Methods: A prospective cohort study of 48 patients who underwent PROSIMA™ mesh kit-related surgical repairs were followed for two years at Peking Union Medical College Hospital. Recurrence was defined as symptomatic POP quantification (POP-Q) Stage II or higher (leading edge ≥ -1 cm). The Patient Global Impression of Change Questionnaire, the Chinese version of the Pelvic Floor Impact Questionnaire short-form-7 and POP/Urinary Incontinence Sexual Questionnaire short-form-12 were used to evaluate the self-perception and sexual function of each patient. Mesh-related complications conformed to the International Urogynecological Association/International Continence Society joint terminology. The paired-sample t-test, one-way analysis of variance, Fisher's exact test, Kaplan-Meier survival analysis and log-rank test were used to analyze data.

Results: All patients were followed up for ≥12 months; 30 (62.5%) patients completed the 24 months study. We observed a 93.8% (45/48) positive anatomical outcome rate at 12 months and 90.0% (27/30) at 24 months. Recurrence most frequently involved the anterior compartment (P < 0.05). Pelvic symptoms improved significantly from baseline (P < 0.05), although the patients' impressions of change and sexual function were not satisfying. Vaginal complication was the main complication observed (35.4%, 17/48). The survival analysis did not identify any relationship between vaginal complication and anatomical recurrent prolapse (POP-Q ≥ Stage II) (P = 0.653).

Conclusions: Tension-free polypropylene mesh (PROSIMA™ )-related surgical repair of POP has better short-term anatomical outcomes at the apical and posterior compartments, but a low patient satisfaction rate. The mesh complications were not the definitive cause of recurrence.

Show MeSH
Related in: MedlinePlus