NCT07401134 Improving Postoperative Recovery: A Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery
| NCT ID | NCT07401134 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Miami |
| Condition | Perineal Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-02-18 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 70 participants in total. It began in 2026-02-18 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research is to determine if using perineal ice packs, medicated witch-hazel pads (MAJOR® Medi-Pads), and topical benzocaine spray (Dermoplast®) helps reduce perineal pain after perineorrhaphy and/or posterior colporrhaphy surgery.
Eligibility Criteria
Inclusion Criteria: * Women ≥ 18 years of age * Undergoing perineorrhaphy and/or posterior colporrhaphy (rectocele repair/posterior repair) as part of their planned vaginal pelvic reconstructive surgery * Physically able to apply medicated witch-hazel pads (MAJOR® Medi-Pads) and administer topical benzocaine spray (Dermoplast®) to the perineal area * Able to understand and willing to provide informed consent Exclusion Criteria: * Known allergy or hypersensitivity to any of the study products or components, including witch hazel, benzocaine, aloe, or other product ingredients * Minors * Presence of an indwelling catheter expected to remain in place for ≥7 days postoperatively * History of chronic pelvic pain syndromes that may confound postoperative pain assessment, including interstitial cystitis/bladder pain syndrome (IC/BPS), endometriosis, pudendal neuralgia, or vulvodynia * Chronic use (\> 3 weeks of continuous use) of opioid pain medication * Presence of vulvar dermatoses such as lichen sclerosus, lichen planus, or lichen simplex chronicus * Currently pregnant or breastfeeding * Anticipated inability to complete postoperative follow-up, including physical or cognitive limitations that would impede self-care or completion of study diaries * Inability or unwillingness to provide informed consent or comply with study procedures
Contact & Investigator
Katherine Amin, MD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT07401134 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Perineal Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07401134 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07401134 currently recruiting?
Yes, NCT07401134 is actively recruiting participants. Contact the research team at katherine.amin@med.miami.edu for enrollment information.
Where is the NCT07401134 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT07401134 clinical trial?
NCT07401134 is sponsored by University of Miami. The principal investigator is Katherine Amin, MD at University of Miami. The trial plans to enroll 70 participants.