A Phase 4 interventional study of Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray in Perineal Injury, Pain Vulva and Perineum; Injury, sponsored by University of Miami. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by University of Miami · Phase 4, Interventional, and Supportive care
Among 47 studies in Vulvodynia with a site in United States — 8 open to participants now, 9 under way, 1 of them phase 3. Vulvodynia · United States.
Among the 47 studies in Vulvodynia with a site in United States, this one is the 9th largest by planned enrollment of the 36 interventional ones that give a count, is one of 3 that started in 2026, is one of 2 in phase 4, and was the 45th registered.
117 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.
Browse Vulvodynia studies →8 of the 47 studies in Vulvodynia with a site in United States are open now. Recruiting first, the newest first:
Center for Vulvovaginal Disorders · Sites in United States
Center for Vulvovaginal Disorders · Sites in United States
Medstar Health Research Institute · Sites in United States
Texas Tech University Health Sciences Center · Sites in United States
Vaginal Biome Science · Sites in United States, Canada
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 13 Vulvodynia studies recruiting now, 8 (62%) set no upper age limit and 5 (38%) stop at 75 or younger; 0 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
47 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 11 · Phase 3 5 · Phase 4 2
First in 2002; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 70 is above the median of 46 across 89 interventional studies indexed under Vulvodynia.
Median enrollment 45 across the 36 interventional studies, 168 across the 11 observational. Of the 34 that completed or were terminated, 14 (41%) have results posted.
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3 of 47 have an industry lead sponsor. The 10 most frequent:
University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
University of Miami has 1 study filed under Vulvodynia — fewer than ten, so there is no comparison to draw.
6 of the studies in Vulvodynia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07486830Center for Vulvovaginal DisordersIncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction | 2026-12-20 |
| NCT07401134University of MiamiImproving Postoperative Recovery: A Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery | 2027-01 |
| NCT05343182Oregon Health and Science UniversityVestibulectomy Surgical Techniques Comparison Study | 2027-04 |
| NCT06472765Vaginal Biome ScienceVaginal Ecosystem and Network in the United States Study | 2027-05-15 |
| NCT01829204Texas Tech University Health Sciences CenterProspective Data Bank Creation to Study Vaginal Conditions | 2027-07 |
Among the 47 studies in Vulvodynia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: 3 Days
Difference in Daily Pain Scores Within Post-Operative Days 0-7 Between Control and MPAP Groups
Pain Score will be assessed using a continuous 10-cm Visual Analog Scale (VAS). It consists of a linear scale with "no pain" at one end (0) and "worst possible pain" at the other (10). To use it, the patient marks the line to indicate their level of pain or sensation. A higher score indicates a more severe level of pain. Daily VAS values will be plotted on a pain-time graph, and will be compared using a mixed-effects model for repeated measures.
Time frame: 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
The number of doses and class of analgesic medication (acetaminophen, NSAIDs, or opioids) will be recorded in a medication diary for control and interventional groups on post-operative days 0-7. A higher number of doses will be interpreted to higher pain burden.
Time frame: 7 Days
Difference in Patient Satisfaction Scores at 2 Weeks Post-Operation Between Control and Interventional Groups
Patient satisfaction with pain management will be measured using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied) at the 2-week postoperative visit. Median scores will be calculated for control and interventional groups. A lower value will indicate lower satisfaction while higher scores indicate higher satisfaction.
Time frame: 2 Weeks
Incidence of Adverse Events Experienced by Participants Within Post-Operative Days 0-7 Between Control and Interventional Groups
Proportion of participants in each study group (control and intervention) who experience any local adverse reaction, including rash, burning, itching, or irritation, at the application site. Reactions will be recorded in participant daily diaries and/or reported during follow-up visits.
Time frame: 7 Days
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Jan 2027, 11 months after the start.
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