Impact of Defecation Posture on Ease of First Bowel Movement Following Posterior Repair

TriHealth

Status: Completed

Conditions: Pelvic Organ Prolapse Vaginal Surgery; Defecation Function; Postoperative Constipation

Treatments: Device: Defecation Posture Modification Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06253689

23-087

Details and patient eligibility

About

This study will determine if defecation posture, when using a defecation posture modification device (DPMD), improves ease with first bowel movement following pelvic reconstructive surgery, specifically posterior repair.

Enrollment: 160 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing surgery by one of the sub investigators including a posterior compartment repair

Exclusion criteria

• Anyone currently using a defecation posture modification device
• Unwillingness or unable to participate in the study
• Presence of ileostomy/colostomy
• Wheelchair bound
• Device may pose fall or safety hazard risk to patient
• Patients weighing over 250 lbs, as per device manufacturer guidelines
• Inability to understand English
• Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Defecation Posture Modification Device

Experimental group

Treatment:

Device: Defecation Posture Modification Device

Control

No Intervention group