A Phase 4 interventional study of Pelvic wand in Pregnancy Related, Pelvic Floor Disorders and Obstetric; Injury, sponsored by Beth Israel Deaconess Medical Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Beth Israel Deaconess Medical Center · Phase 4, Interventional, and Supportive care
There is limited research on the optimal strategy to reduce obstetric laceration, postpartum urinary retention, and postpartum pelvic pain. In systematic reviews, clinician-directed massage of the perineal muscles at the time of birth and patient directed massage of the perineal muscles in the third trimester to inconsistently reduce the incidence of severe obstetric laceration.1,2 However, there is significant heterogeneity of these studies is due in large part to the lack of a standardized protocols and unpredictability of clinician availability to perform perineal massage around the time of birth.
The purpose of this study is to understand how perineal massage with a pelvic wand in late pregnancy and during labor influences one's sense of self-control over the labor process and birth experience.
Study Overview and Design This is a randomized controlled, single-center study to assess the effect of the Intimate RoseTM Pelvic Wand device (Figure 1) on the birth experience.
Methods Recruitment We will enroll eligible adult pregnant patients who plan to give birth at BIDMC.
Randomization After providing consent, we will randomize participants in a 1:1 ratio to the intervention or control arm.
Enrollment and Antepartum Period The intervention arm will receive standard of care education about the benefits of perineal massage and receive instruction to perform the massage three times weekly. They will then watch a 2-minute video to demonstrate proper use and cleaning of the device to assist with antepartum perineal massage. Trained study personnel will also be avilable to answer questions on proper use, storage, and cleaning. Participants will be provided with the pelvic wand at enrollment and asked to use the device at least three times weekly for 10 minutes begining at enrollment until their hospitilization for birth. This frequency and duration are what is recommended by pelvic floor physical therapists and is their standard of care.
The control arm will receive standard of care verbal education about the benefits of self-directed (or partner) manual perineal massage in the antepartum period and during the birthing process. They will be given the device after birth before hospital discharge.
Participants will be told to call their primary obstetric provider if they experience any symptoms when using the device or doing manual massage.
Device Use on Labor \& Delivery The intervention arm will be asked to utilize the device every hour for at least 5 minutes. The participant will utilize the device until the second stage of labor (the onset of pushing), at which point the provider or bedside nurse can assist the participant in performing the perineal massage, which is the current standard of care on the BIDMC labor and delivery unit.
The control arm will perform perineal massage if they choose; there will be no research interaction with control arm participants on Labor and Delivery. We will give the device to the control arm participants after birth and before discharge in their postpartum room. As with the intervention group, they will be given the 2-minute video to demonstrate propoer use and cleaning, and they will be given an opportunity to ask questions.
Device Use During the Postpartum Period All participants will be asked to use the device at least three times weekly for 10 minutes after they receive clearance from their obstetric provider at their six-week postpartum visit. Study staff will call the participants to remind them on the instructions for use that were previously supplied. Participants will be asked to use the device until 12 weeks postpartum.
Participant Questionaries Participants will be asked to track their use of the device or manual massage and to complete the following questionnaires to assess their birth experience prior to hospital discharge and pelvic floor dysfunction and urinary dysfunction to be assessed at time of enrollment, 6 weeks postpartum, and 3 months postpartum.
197 studies on the registry are indexed under Pelvic Floor Disorders; 45 are open to participants now.
This study's planned enrollment of 140 is above the median of 64 across 136 interventional studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention arm will receive standard of care education about the benefits of perineal massage and receive instruction to perform the massage three times weekly. They will then watch a 2-minute video to demonstrate proper use and cleaning of the device to assist with antepartum perineal massage. Trained study personnel will also be available to answer questions on proper use, storage, and cleaning. Participants will be provided with the pelvic wand at enrollment and asked to use the device at least three times weekly for 10 minutes beginning at enrollment until their hospitalization for birth. This frequency and duration are what is recommended by pelvic floor physical therapists and is their standard of care.
Device: Pelvic wand
The control arm will receive standard of care verbal education about the benefits of self-directed (or partner) manual perineal massage in the antepartum period and during the birthing process. They will be given the device after birth before hospital discharge.
Use of a pelvic wand to perform perineal massage
Mean score difference between the two arms on the Labor Agentry Scale
A clinically significant difference is defined as a mean score difference of 10 points
Time frame: During hospitalization (assessed up to 5 days)
The average number of completed massage sessions prior to hospitalization
The average number of completed massage sessions measured by analyzing diary responses between enrollment and admission to the hospital for birth
Time frame: 6-8 weeks prior to birth event
The average number of completed massage sessions during hospitalization
The average number of completed massage sessions measured by analyzing diary responses during birth hospitalization.
Time frame: 24-48 hours
The average number of completed massage sessions postpartum
The average number of completed massage sessions measured by analyzing diary responses in the postpartum period
Time frame: 6 weeks post birth time point
Number of patients with postpartum urinary symptoms
Number of patients with postpartum urinary symptoms based on survey responses.
Time frame: 12 weeks postpartum
Number of patients with pelvic floor dysfunction in the postpartum period
Number of patients with pelvic floor dysfunction based on survey responses using the Pelvic Floor Distress Inventory 20 Questionnaire (PFDI-20) Female Sexual Function Index (FSFI)
Time frame: 6 weeks postpartum and 12 week postpartum
obstetric lacerations at time of delivery
The number of patients with obstetric lacerations at time of delivery
Time frame: During hospitalization (assessed up to 5 days)
Plan to share: Undecided — De-identified data may be shared on a case by case basis
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Beth Israel Deaconess Medical Center