Outcomes of Single Incision Anchored Anterior Vaginal Mesh Repair for Recurrent Vaginal Prolapse

Loganathan J1, Fayyad A1

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 681
Non Discussion Abstracts
Scientific Non Discussion Abstract Session 36
Female Pelvic Organ Prolapse Prolapse Symptoms Surgery Quality of Life (QoL)
1. Luton and Dunstable University Hospital NHS Foundation Trust
Links

Abstract

Hypothesis / aims of study
We aim to report the safety, efficacy and complications of single incision anchored anterior vaginal mesh repair kits (Elevate PC and Restorelle DirectFix) in the surgical treatment of women with recurrent anterior vaginal wall prolapse.
Study design, materials and methods
All patients with symptomatic recurrent anterior vaginal prolapse following native tissue repair were offered single incision vaginal mesh insertion as a management option.

Consecutive patients with recurrent anterior vaginal prolapse of Stage 2 or beyond who underwent single incision anchored anterior vaginal mesh repair with either Anterior Elevate (American Medical Systems, Minnetonka, USA) or Restorelle DirectFix (Coloplast) from June 2012 to October 2016 were evaluated. 

Pre operatively, all patients were assessed using the Prolapse Quality-of-Life questionnaire (P-QOL) (1), Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 (PISQ-12) (2) and the Pelvic Organ Prolapse Quantification System (POP-Q) (3). 

Post-operatively, patients completed the P-QOL, PISQ-12 and the global impression of improvement questionnaires (PGI-I) and were examined using the POP-Q system at 3 months, and yearly up to 2 years post operatively. 

Patients were then interviewed using a structured telephone interview that included questions from the P-QOL, PISQ and PGI-I. The interview and data analysis were conducted by an independent clinician, who was not involved in the surgery. The need for further surgery for prolapse and mesh-related complications were reviewed. Follow up interval ranged from 7 months to 60 months with an average of 36 months. 

The primary outcome measure is the number of women with symptomatic cure of their bulge symptoms, defined as ‘none’ or ‘a little’ in the domain of vaginal bulge in the P-QOL questionnaire. Secondary outcomes include patient global impression of improvement and anatomical position of the anterior vaginal wall (Point Aa and Point Ba) and apex (Point C) using POPQ.
Results
During the study period 55 women had single incision anterior vaginal mesh kit repair for recurrent prolapse, 45 anterior Elevate PC and 10 Restorelle DirectFix.

Postoperatively, 85% (34/40) of patients reported cure of their prolapse symptoms. 
At mean follow up of 36 months, on assessing patient global impression of improvement, PGI-I, 70% (28/40) reported feeling ‘much better’ or ‘very much better’ (Table 1). Three patients reported feeling worse; one with bothersome urinary urgency and frequency symptoms, one with recurrent prolapse symptoms, and one with a combination. Both patients with urinary symptoms underwent cystoscopy with no evidence of mesh extrusion into the urinary tract. 

On assessing patients’ quality of life domains in the P-QOL questionnaire post operatively, significant improvements were reported in all QOL domains apart from general health (Table 2).

Preoperatively 44% of women were sexually active, and 40% postoperatively. 
93.8% patients who were sexually active postoperatively reported ‘none’ or ‘a little’ in response to the question ‘vaginal bulge which gets in the way of sex’. 
5 patients had dyspareunia preoperatively that was cured following surgery. 3 patients reported ‘new onset’ dyspareunia as ‘always’ after surgery. 

Anatomically, at two years post operatively, 80.0% had POP-Q Stage 0 or 1 in the anterior compartment (point Ba) and anatomical cure of apical prolapse (point C above 0) was achieved in 93.8% of patients that had preoperative apical prolapse of Stage 2 and beyond.
Interpretation of results
In this study we found that at mean follow up of 36months, the subjective cure rate of single incision mesh kit was 85%, with objective cure rate of 80% in the mesh compartment. This study also shows that anchored single incision mesh improved apical support in almost 94% of women with concomitant apical prolapse. Therefore this technique can be considered to treat vaginal apical prolapse for women where abdominal approach with sacrocolpopexy may be considered more hazardous. 

Our study found that the majority of women were not sexually active preoperatively, but that the underlying reasons for this were multifactorial and often not solely due to prolapse. Of those who experienced dyspareunia preoperatively (6 of 18 women) the majority improved, with 5 women reporting cure of dyspareunia post operatively. Development of de novo dyspareunia was also recorded however, with 3 women reporting de novo symptoms (25%).
Concluding message
This study shows that vaginal surgery using single incision lightweight mesh kits is an effective approach for women with recurrent anterior vaginal prolapse, resulting in subjective and objective cure rates of over 80% with reasonable safety profile up to 60 months post operatively.
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References
  1. Int Urogynecol J Pelvic Floor Dysfunct. 2005 May-Jun;16(3):176-81 P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S.
  2. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8 A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C.
  3. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Bump RC, Mattiasson A, Bø K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR.
Disclosures
Funding None Clinical Trial No Subjects Human Ethics not Req'd Approved by Hospital Interventional Procedures Governance Committee and the Institutional Review Board. Helsinki Yes Informed Consent Yes