• Percent change in total ODS symptom composite score one year post procedure
  

• Percent change in ODS symptom composite score from baseline at 1 month, 6 months, 2 years, 3 years, 4 years and 5 years
  
• Change in patient condition scores from baseline at 1 month, 6 months and 1 year; to be assessed as patient-reported assessment of symptom severity and frequency (PAC-SYM), and quality of life (PAC-QOL and SF-12)
  
• Change from baseline in urge to defecate
  
• Change from baseline in dynamic defecography parameters (including anterior rectocele depth, anteroposterior diameter of rectum) at rest and during evacuation at 6 months postoperative
  
• Global assessment of change in bowel condition by both the investigator and the subject
  
• Patient surgery satisfaction assessment at 1 month, 6 months, and 1 year postoperative
  
• Change from baseline in anorectal pain at onset of defecation at 1 month postoperative
  
• Incidence of dyspareunia at baseline, 1 month, 6 months, and 1 year postoperative
  

Rectocele and rectal intussusception are frequent findings in women but are often asymptomatic apart from anatomical defects, which can be seen on vaginal examination. They can be associated, however, with refractory constipation that may be best described by the terms "Outlet Obstruction" or "Obstructive Defecation Syndrome (ODS)". ODS is characterized by a symptom complex, including the feeling of incomplete evacuation associated with the need to strain excessively and for external assistance (digital, mechanical or positional maneuvers, enemas or suppositories) to aid defecation. Abdominal or rectal pain is also a common complaint. Obstetric trauma is also recognized as a contributing factor. However, none of these symptoms/factors can be singled out to be pathognomonic for this problem. ODS has a prevalence of approximately 12% in the general population.

For individuals with ODS and related intussusception/rectocele, a variety of surgical techniques including abdominal, vaginal, transanal and perineal approaches have been devised. The impact of clinical studies to evaluate these techniques has been limited by variability of results and lack of comparators. Recently, a new surgical approach was developed by an Italian surgeon, A. Longo, and has been evaluated in several European centers. These early studies and observations indicate that this new procedure may in fact provide significantly better symptom resolution in ODS patients than other available treatments, and warrants further study. The procedure is referred to as "Stapled Transanal Rectal Resection (STARR)" and this study will assess its effectiveness in a United States population.