Gynecologic Surgeries, Pelvic Organ Prolapse, Postoperative Pain Management
Conditions
Keywords
Pelvic organ prolapse surgical repair
Brief summary
The purpose of this study is to evaluate the utility of postoperative sitz baths in patient pain perception and recovery following surgical repair of prolapse. The SORE Study is a prospective, randomized controlled trial that aims to compare postoperative pain intensity one week after native tissue repair of pelvic organ prolapse for patients undergoing a sitz bath regimen versus usual care. Findings from this study may contribute to more robust, multimodal postoperative pain management plans if proven efficacious or, alternatively, reduce plastic medical waste and simplify postoperative pain plans if found to be ineffective.
Detailed description
The primary objective of the SORE study is to compare postoperative pain intensity one week after native tissue repair of pelvic organ prolapse for patients undergoing a sitz bath regimen versus usual care. The secondary objectives of this study are to evaluate patient satisfaction with pain management after native tissue prolapse repair (and specifically posterior repair and/or perineorrhaphy), patient-reported opioid requirements, healthcare utilization, postoperative pain plan adherence, and incisional healing and complications between those undergoing a sitz bath regimen versus usual care.
Interventions
DEVICESitz Bath
Warm water sitz bath, 7 nights, 10 minutes each
Sponsors
Yale University
American Urogynecologic Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The study population will consist of adult patients undergoing native tissue surgical repair of pelvic organ prolapse at a Yale-affiliated hospital.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female ≥ 18 years of age at time of surgery * English or Spanish-speaking * Documentation of pelvic organ prolapse as evidenced by Stage 2, 3, or 4 prolapse on preoperative Pelvic Organ Prolapse Quantification system (POP-Q) examination * Surgery to be performed by a urogynecologist * Ambulatory or inpatient surgery acceptable
Exclusion criteria
* Mesh-augmented prolapse repair (robotic, laparoscopic, or open sacrocolpopexy or sacrohysteropexy, vaginal mesh) * Urogynecologic surgery without prolapse repair (i.e. midurethral sling, intravesicular botox, hysterectomy only) * Suspected genital herpes simplex virus (HSV), molluscum contagiosum virus (MCV), condyloma acuminata, or vulvar/vaginal skin and soft tissue infection at recruitment by patient report * Daily opioid use (short or long-acting) * Concurrent non-urogynecologic surgery (i.e. rectopexy, staging or debulking for malignancy) * Lack of access to operative report * Pregnant (as determined by positive urine pregnancy test on the day of surgery via standard testing or current pregnancy documented in the preoperative note) * Incarcerated * Unable to give consent/conserved * Unable to complete study intervention or assessment per investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System Pain Intensity (PROMIS-PI) short form 3a questionnaire | Day 7 Post surgery | Pain intensity will be assessed on a 15-point scale evaluating current, worst, and average pain on postoperative day 7 following prolapse repair and converted to a T- score using general population data. Higher scores indicate increased pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sitz bath use- Adherence | Day 7 Post surgery | Total use of sitz baths in minutes |
| Barriers to use- Adherence | Day 7 Post surgery | Number of barriers to use perceived by self-report |
| Number of participants with rare adverse effects | Day 7 Post surgery | Number of participants with any rare adverse effects per protocol |
| Mean Opioid use | Day 7 Post surgery | Mean number of requests for opioid refills postoperatively |
| Mean number of calls regarding pain | Up to Day 90 Post surgery | Mean number of calls or messages for postoperative pain within 90 days of surgery via review of medical record |
| Mean number of Emergency Department visits | Up to Day 90 Post surgery | Mean number of emergency department visits within 90 days of surgery via review of medical record |
| Comfort with postoperative pain plan | Day 7 Post surgery | Participant comfort level with managing postoperative multimodal pain plan on a 5-point Likert scale (1 = very uncomfortable, 5 = very comfortable) |
| Mean score patient satisfaction | Day 7 Post surgery | Satisfaction with postoperative pain management on a 0-100 mm visual analog scale |
| Comfort with postoperative pain plan using Sitz bath | Day 7 Post surgery | Participant comfort with sitz bath setup and cleanup, accessibility to bathroom use, physical comfort during and after use of sitz bath on a 5-point Likert scale (1 = very uncomfortable, 5 = very comfortable) |
| Mean Oxycodone use | Day 7 Post surgery | Mean number of oxycodone tablets used postoperatively |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNancy Ringel, MD, MS
Yale University
Outcome results
None listed