An interventional study of Graft augmented posterior repair and Control in Rectocele, sponsored by Women and Infants Hospital of Rhode Island. Completed at 1 site in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Women and Infants Hospital of Rhode Island · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether adding a graft during a rectocele repair will improve the success rate of the repair.
Rectoceles may have a significant effect on the quality of life of women. Symptoms associated with rectoceles include a protruding vaginal mass, persistent pelvic pressure, and sexual dysfunction. Surgical repair is the most common treatment with success rates ranging from 65%-85% at 1-2 years. In an attempt to improve surgical outcomes, clinicians are using graft materials to augment weakened tissues in rectocele repairs: however, there is little data to support or refute these practices. The purpose of this study is to estimate the effect of graft augmentation on objective and subjective outcomes.
Comparison: Rectocele repair without graft, compared to rectocele repair with the SurgiSIS (TM) graft.
50 studies on the registry are indexed under Rectocele; 9 are open to participants now.
This study's enrollment of 160 is above the median of 62 across 37 interventional studies indexed under Rectocele.
Browse Rectocele studies →Women and Infants Hospital of Rhode Island is the lead sponsor of 93 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Native tissue repair
Procedure: Control
Posterior repair with graft
Procedure: Graft augmented posterior repair
Posterior repair with graft
Native tissue repair
Anatomic cure defined by standardized POPQ measures
Time frame: 12 months
Quality of life based on PFIQ validated questionnaire
Time frame: 12 months
Sexual function
Time frame: 12 months
Patient centered goals
Time frame: 12 months
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Women and Infants Hospital of Rhode Island