Improving Postoperative Recovery: A Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery

NCT07401134 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 20251232
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Perineal Injury; Pain Vulva; Perineum; Injury

Outcome Measures

Primary Outcomes (1)

• Difference in Perineal Pain Score on Postoperative Day (POD) 3 Between Control and Interventional Groups

  Perineal Pain Score will be assessed using a 10-cm Visual Analog Scale (VAS). It consists of a 10 cm line with "no pain" at one end (0) and "worst possible pain" at the other (10). Participants will mark the line to indicate their level of pain or sensation. A higher score indicates a more severe level of pain.

  3 Days

Secondary Outcomes (4)

• Difference in Daily Pain Scores Within Post-Operative Days 0-7 Between Control and MPAP Groups

  7 Days

• Difference in Total Number of Doses of Each Class of Analgesic Medications Within Post-Operative Days 0-7 Between Control and Interventional Groups

  7 Days

• Difference in Patient Satisfaction Scores at 2 Weeks Post-Operation Between Control and Interventional Groups

  2 Weeks

• Incidence of Adverse Events Experienced by Participants Within Post-Operative Days 0-7 Between Control and Interventional Groups

  7 Days

Study Arms (2)

Multimodal Perineal Analgesic Protocol (MPAP)

EXPERIMENTAL

Participants will follow the Multimodal Perineal Analgesic Protocol (MPAP) in addition to their normal post-operation care. Participants will receive a Perineal Care Kit prior to discharge from the hospital. This kit will contain: * 14 perineal ice packs * One container of 100 medicated witch-hazel pads (MAJOR® Medi-Pads) * One 2.75 oz can of 20% benzocaine with aloe spray (Dermoplast®) Participants will also receive standard discharge instructions, including guidance on perineal hygiene, scheduled pain relievers, activity restrictions, constipation prevention, and catheter care if a catheter has been placed.

Drug: Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray

Normal Post-Operation Care

NO INTERVENTION

Participants will receive standard discharge instructions, including guidance on perineal hygiene, scheduled pain relievers, activity restrictions, constipation prevention, and catheter care if a catheter has been placed.

Interventions

Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray DRUG

Participants will follow the Multimodal Perineal Analgesic Protocol (MPAP) in addition to their normal post-operation care. Participants will receive a Perineal Care Kit prior to discharge from the hospital. This kit will contain 14 perineal ice packs, one container of 100 medicated witch-hazel pads (MAJOR® Medi-Pads), and one 2.75 oz can of 20% benzocaine with aloe spray (Dermoplast®). Participants will receive written instructions for use of these products.

Multimodal Perineal Analgesic Protocol (MPAP)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Hospitals and Clinics

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Vulvodynia; Wounds and Injuries

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Katherine Amin, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Amin, MD

CONTACT

(305) 243-6590; katherine.amin@med.miami.edu

Tamar Yacoel, MD

CONTACT

(972) 282-0072; t.yacoel@umiami.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Urology

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 10, 2026
• Study Start: February 18, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)