Perineal InjuryPhase 4NCT07401134
Improving Postoperative Recovery: A Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery
A Phase 4 study testing Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray in people with Perineal Injury and Pain Vulva, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perineal Injury, Pain Vulva, Perineum; Injury
- What is being tested?
- Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2026to Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami Hospitals and Clinics
Miami, Florida, 33136
Elena Cortizas, 305-243-3593, ecortizas@med.miami.edu
Katherine Amin, MD
About this study
Official title: Improving Postoperative Recovery: A Randomized Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery
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
- Being tested
- Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray
- Medical subject headings
- Vulvodynia, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal ice packs, medicated witch-hazel pads, and topical benzocaine sprayDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start18 Feb 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal InjuryStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Amin, University of Miami
- Investigators
- Katherine Amin, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401134
- Sponsor's protocol ID
- 20251232
- Status last verified
- Mar 2026
- First submitted
- 28 Jan 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Postoperative Recovery: A Randomized Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery
- ClinicalTrials.gov ID
- NCT07401134
- Acronym / sponsor ID
- 20251232
- Conditions
- Perineal Injury, Pain Vulva, Perineum; Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Perineal Analgesic Protocol (MPAP) | Experimental | Drug: Perineal ice packs, medicated witch-hazel pads, and topical benzocaine sprayParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal ice packs, medicated witch-hazel pads, and topical benzocaine sprayParticipants 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. | Drug | Multimodal Perineal Analgesic Protocol (MPAP) |
Primary outcome
Difference in Perineal Pain Score on Postoperative Day (POD) 3 Between Control and Interventional Groups
Time frame: 3 Days
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.
4 secondary outcomes
Difference in Daily Pain Scores Within Post-Operative Days 0-7 Between Control and MPAP Groups
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
Time frame: 7 Days
Difference in Patient Satisfaction Scores at 2 Weeks Post-Operation Between Control and Interventional Groups
Time frame: 2 Weeks
Incidence of Adverse Events Experienced by Participants Within Post-Operative Days 0-7 Between Control and Interventional Groups
Time frame: 7 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Amin, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray in people with Perineal Injury and Pain Vulva, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Amin, MD ((305) 243-6590, katherine.amin@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Perineal Pain Score on Postoperative Day (POD) 3 Between Control and Interventional Groups (time frame: 3 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.