Improving Postoperative Recovery: A Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery
Recruiting
Phase 4Interventional Study
Perineal InjuryPain VulvaPerineum; Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 4
Study type
Interventional
Purpose
Supportive Care
Participants needed
70 (estimated)
Sponsor
University of Miami · Other
Who this trial is looking for
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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.
Trial Locations
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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 …
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
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