BridgeMD
New treatment option for Perineal Injury
Official title Improving Postoperative Recovery: A Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery
ClinicalTrials.gov ID: NCT07401134
What this study is testing
What is Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray?
Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for perineal injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women ≥ 18 years of age
- Undergoing perineorrhaphy and/or posterior colporrhaphy (rectocele repair/posterior repair) as part of their planned vaginal pelvic reconstructive...
- 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 likely can't join 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.