Study design, materials and methods
The trial was conducted between 2010 to 2015.
Women with symptomatic uterovaginal prolapse POP-Q stage ≥ 2 in at least one compartment requiring surgery who attended the pelvic floor clinic of our hospital were recruited. Patients with co-existing concomitant incontinence surgery were included. Women with language barriers, neoplasms, autoimmune or hematological diseases, abnormal uterine bleeding, and ultrasound uterine/ovarian findings were excluded.
All participants signed a consent form, the study was approved by the Ethics Committee of our hospital.
Follow-up visits were made at 12, 36, and 60 months. In all the visits gynecological examination, POP-Q, and ultrasound were performed and validated QoL surveys were answered.
Two surgery groups were designated by computer-generated randomized table:
1. Vaginal hysterectomy with anterior vaginal colporrhaphy and perineal body repair with Vicryl stitch
2. Hysteropexy with TFS® mesh to arcus tendinous, parametrium and uterosacral, anterior vaginal colporrhaphy, and perineal body repair with Vicryl stitch.
Posterior vaginal colporrhaphy was performed when appropriate, and suburethral/TVT mesh was applied to correct stress urinary incontinence if appropriate.
We do not show in this abstract the validated QoL survey results.
The primary outcome measure was POP anatomical recurrence at 12, 36, and 60 months. We considered POP anatomical recurrence when the POP-Q stage was ≥ 2. The secondary outcome considered whether the percentage of recurrences changed over time at 12, 36, and 60 months. Also as the secondary outcome, we analyzed if the urogenital hiatus area to the Valsalva > 25 cm 2 is able to play a role in the POP recurrence
We used the X2 test, Fisher’s Exact Test and independent t-test, Cochran’s Q test, and logistic regression as appropriate, and data were analyzed with the statistical method IMB SPSS Statistics version 26
A final total of 38 patients were included in the hysteropexy group and 32 in the vaginal hysterectomy group.
Interpretation of results
Analyzing the POP anatomical recurrence at 12, 36, and 60 months, the hazard of recurrence seemed the largest when a hysterectomy is performed, however, there was no statistically significant difference between surgical techniques (Figure 2).
There was no difference in POP anatomical recurrence over time between prolapse repair with hysteropexy or vaginal hysterectomy (p-value Cochran’s Q test =0.307).
Logistic regression analysis identifies hiatus area > 25 cm2 at 12 months as a predictor (or risk factor) of POP anatomical recurrence. The multivariate analyses were adjusted for age at the surgery, body mass index and surgical techniques and OR = 3.55 (95% CI 1.12-11.24).