Study design, materials and methods
The trial was conducted between 2010 to 2015.
Women with symptomatic uterovaginal prolapse POP-Q stage ≥ 2 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, anormal uterine bleeding, ultrasound uterine/ovarian findinds were excluded.
All participants signed an informed consent, the study was approved by the Ethics Committee of our hospital.
Follow-up visits were made at 12, 36 and 60 months, respectively. In all the visits gyneco-logical examination, POP-Q and ultrasound were performed and validated QoL surveys were answered.
Two surgery groups were designated:
1. Vaginal hysterectomy with anterior vaginal colporrhaphy and perineal body repair with Vicryl stich
2. Hysteropexy with TFS® mesh to arcus tendineus, parametrium and uterosacral, anterior vaginal colporraphy and perineal body repair with Vicryl stich
Posterior vaginal colporrhaphy was performed when appropriate, suburethral/TVT mesh were applied to correct stress urinary incontinence if appropriate.
The main objective was analyzing whether the urogenital hiatus area could be modified with POP surgery, and a secondary objective was to observe whether there was any difference depending on the surgical technique used. We have not show in this abstract the validated QoL surveys results.
We compared all the patients, regardless of the surgical technique used, analyzing the POPQ before surgery, at 12, 36 and 60 months with the area of the urogenital hiatus to the Valsalva: one group with a hiatal area ≤ 25 cm 2 and another group with hiatal area > 25 cm 2.
The hiatal area measured before surgery, 12, 36 and 60 months has also been compared depending on whether a vaginal hysterectomy or a hysteropexy has been performed.
Patients were assigned by computer-generated randomized table.
The patients could not be masked because they were different surgical techniques.
We used the Student’t / Wilcoxon distribution as appropriate and data were analyzed with the statistical method Stada version 14.1
One patient was recruited but did not undergo surgery, another died after the third year, another had dementia after the first year, 13 did not attend all controls, and 3 dropped out of the study. A final total of 41 patients were included in the hysteropexy group and 33 in the vaginal hysterectomy group.
In 2015 we stopped the trial due to lack of supply of TFS® by the distributor. We continue with the follow-up of the patients up to 5 years as designed.
Interpretation of results
Analyzing the hiatal area to Valsalva, we found no significant results between the presence of > 25 cm 2 hiatal area and the presence of a higher degree of POP before and after surgery.
We also found no significant differences between the different surgical techniques and the hiatal area before and after surgery.
Yes, both surgical techniques reduce the hiatal area after surgery