This is the first prospective randomized study comparing colposacropexy ( CSP) with hight uteroscral vault suspention (HUVS) in the treatment of apical prolapse.
In this study the primary outcome was anatomical success defined as POP-Q point C less than stage 2 and our study shows significant better anatomical results in apical compartments, as in another compartments, at 12 month follow up.
Today is well known that symptoms and their impact in quality of life and the re intervention date for prolapse are important elements and must be included in the definition of success. Eventhough these variables were not included in the primary objective of our study, they were evaluated as secondary outcomes. The reoperation rate for prolapse was significantly higher for HUVS vs SCP ( 5.6% vs 17%, p=0.04) but the symptoms (evaluated by PFDI-20 ) and their impact in quality of life ( evaluated by P-Qol questionary ) improved in the same proportion from the pre-operatory to post-operatory between both procedures.
It is very important to note that HUVS maintains the previously reported benefits of vaginal surgery; such as shorter operating time and hospital stay with less post operative morbidity compared to patients undergoing SCP.
The strength of this study is that it is a prospective randomized study, performed by a few surgeons with a standardized technique. All the patients were properly assed by an experience gynecologist with proper use of POP-Q and by validated questionnaires. There were no lost of follow up of patients and there was no transfer between each group.
The main limitation of our study was the fact that the post operative evaluation was performed by members of the surgical team who performed the surgery and they were not blinded to the group which patients belong.
Based in these results in our own practice we recommend HUVS in sexually active elderly women with probably less severe prolapse and some co-morbidities and in younger patients, specially with severe apical prolapse, we recommend CSP.
A special comment deserves the high numbers of re-intervention in a short period of follow up in HUVS group. If we analyze the survival curve for apical compartment we can see that most of recurrence occurs between 6-12 months. One possible explanation could be fact that we used Polydioxanone to perform HUVS. In a recent prospective randomized study presented by our unit in the last IUGA meeting in Nice, France we compared permanent versus delayed reabsorbable sutures in uterosacral ligament suspension for the treatment of apical compartment demonstrated that anatomical cure rate , when cure was defined as POP-Q point C < stage 2, was significant higher for Polipoprileno vs Polydioxanone at 24 month follow up (97% vs 79.2%, p<0.03). 1
Finally in the IUGA/ICS Joint report on the terminology for reporting outcomes of surgical procedures for Pelvic Organ Prolapse they recommend to perform studies with long term follow up defined as 3-5 years follow up. 2 We already presented the results of this study with 4 years follow up in the 38th Annual IUGA Meeting, Dublin, Ireland, 2013 and the results showed even bigger differences in anatomical results in favor to SCP but again with out significant differences in subjective results 3. We hope to publish this study in the next months.
1. In Urogynecol J (2015) 26 (Suppl 1):S1.Podium Presentation 04
2. Neurourology and urodynamics (2012) 31:415-421
3. In Urogynecol J (2013) 24 (Suppl 1):S5.Podium Presentation 004
Hospital Padre Hurtado, Esperanza 2150, San Ramón, Santiago, Chile.