Recruiting

Perineal Pain Treatment

Sponsor:

University of Miami

Code:

NCT07401134

Conditions

Perineal Injury

Pain Vulva

Perineum; Injury

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT07401134

Start date

Feb 18, 2026

Status verified date

Mar, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Multimodal Perineal Analgesic Protocol (MPAP)

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.

no intervention: Normal Post-Operation Care

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

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.

Primary outcome measure

  • Difference in Perineal Pain Score on Postoperative Day (POD) 3 Between Control and Interventional Groups [ Time Frame: 3 Days ]

Central Contacts and Locations

Central contacts

Katherine Amin, MD

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

Tamar Yacoel, MD

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

Locations

University of Miami Hospitals and Clinics

Recruiting

Miami, Florida, United States, 33136

Contacts

Elena Cortizas

305-243-3593ecortizas@med.miami.edu

Principal Investigator:

Katherine Amin, MD

More Information

Sponsor

University of Miami

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-04.