Perineal Massage for Prolapse

Overseen By Rodney Stephenson

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Pain medications

Disqualifiers: Non-English, Vaginal erosion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 visits

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if perineal massage (also known as perineal stretching or vaginal massage) can make pessary checks more comfortable. Pessaries, used to help with pelvic organ prolapse, can sometimes cause discomfort during checks. The trial compares the effects of a brief massage with a water-based gel to using the gel alone. Women who regularly undergo pessary checks at the UNC Urogynecology office and can attend two visits might be suitable candidates. Participants will report their pain levels and preferences to help researchers assess whether massage makes a difference. As an unphased trial, this study allows participants to contribute to research that could enhance comfort during medical procedures.

Will I have to stop taking my current medications?

If you regularly use pain medications like lidocaine for pessary checks, you will need to stop using them for the two study visits.

What prior data suggests that perineal massage is safe for improving comfort during pessary checks?

Studies have shown that perineal massage can reduce the risk of injuries during childbirth. This suggests it might also help with discomfort during pessary checks. Specifically, research indicates that perineal massage can lower the risk of severe tears by about 51%. Other studies have found that it can also reduce pain during labor.

Since perineal massage is already used to help during childbirth, it seems generally safe. No major reports have indicated it causes harm. Instead, it appears to help by making the tissue more flexible and less likely to tear.

This trial explores whether perineal massage can make pessary checks more comfortable. While its effectiveness for this purpose remains unclear, its use in other areas suggests it could be a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the perineal massage trial because it explores a potentially simple and non-invasive technique to improve the comfort and effectiveness of pessary examinations for prolapse. Unlike traditional treatments that focus on surgical or device interventions, this approach is about manually preparing the tissue, possibly making examinations less uncomfortable. This method could lead to better patient experiences and outcomes without the need for more invasive procedures.

What evidence suggests that perineal massage is effective for improving comfort during pessary checks?

Research has shown that perineal massage can help reduce pain in women. One study found that women who received a perineal massage experienced less intense pain. Another study demonstrated that performing this massage during labor eased pain for first-time mothers. The massage increases the flexibility of the skin and muscles, making them less sensitive. In this trial, participants in one arm will receive perineal massage before a pessary examination. This could make the use of pessaries, devices that support pelvic organs, easier and more comfortable for women. ^{6 7 8 9 10}

Who Is on the Research Team?

Christine Chu, MD, MSCI

Principal Investigator

University of North Carollina at Chapel Hill

Are You a Good Fit for This Trial?

This trial is for women who use pessaries to manage conditions like urinary incontinence and uterine prolapse. Participants should be following up with the Urogynecology division at UNC for pessary checks. The study excludes specific details on eligibility criteria, but typically those with allergies or conditions that could interfere with the treatment may not qualify.

Inclusion Criteria

Able to provide informed consent (as reported by patient or family member)

I am currently receiving pessary care from my healthcare provider.

Able to follow up with the UNC Urogynecology office for two consecutive pessary examination

Exclusion Criteria

I use pain medication like lidocaine for pessary checks and can't skip it for two study visits.

Found to have a condition such as significant vaginal erosion that precludes replacement of pessary after exam

I visited the doctor for pessary issues like pain, it falling out, or heavy bleeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo perineal massage or no massage before pessary examination in a cross-over design

2 visits

2 visits (in-person)

Follow-up

Participants are monitored for discomfort and satisfaction with perineal massage

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Perineal Massage

Trial Overview

The trial tests if perineal massage before a pessary check can make it more comfortable. Women will either receive a perineal massage or just have gel applied without massage before their pessary examination, and then switch methods on their next visit.

How Is the Trial Designed?

Group I: Perineal massage before pessary examination Experimental Treatment 1 Intervention

Participant will undergo 2 minutes of perineal massage with water-based gel prior to the pessary examination. This consists of 2 minutes of perineal massage at the external perineum and sides of the vaginal vestibule, as well as internal massage with the thumb, gliding from 4 to 8 o'clock, then tissue stretching technique with one intracavitary finger and other external finger at the 4 o'clock and 8 o'clock positions three times. The massage will be done by trained doctors who are not performing the pessary check.

Group II: No perineal massage before pessary examination Active Control 1 Intervention

Participant will not undergo 2 minutes of perineal massage, but will have water-based gel applied to the vaginal introitus and perineum prior to the pessary check.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

The pilot study demonstrated that a randomized controlled trial on perineal massage during pregnancy is feasible, with a participation rate of 26.4% among approached women and high adherence in the massage group, where 91% maintained a diary of their practice.

The study also showed that the attending physician could remain mostly blind to the participants' group assignments, with only 6.7% of cases where the physician was aware, indicating that the trial design could effectively minimize bias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of perineal trauma by perineal massage during pregnancy: a pilot study. Labrecque, M., Marcoux, S., Pinault, JJ., et al.[2019]

Ante-natal perineal massage (APM) is suggested to be an effective and safe technique for reducing perineal trauma during vaginal delivery, particularly beneficial for first-time mothers (primiparous women).

A review of ten studies indicates that APM may also help alleviate postpartum pain in women who have given birth before (multiparous women), although more research is needed to strengthen these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Update on the effectiveness and evidence of ante-natal perineal massage]. Azón, E., Mir, E., Hernández, J., et al.[2021]

A study involving 144 Thai pregnant women revealed that 83% had a positive attitude towards antenatal perineal massage, indicating a high level of acceptability for this practice aimed at preventing obstetric anal sphincter injuries.

Despite the high acceptability, only 15% of participants were aware of antenatal perineal massage, highlighting the need for education and awareness programs to inform pregnant women about its benefits and proper techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge, attitude and acceptability regarding antenatal perineal massage in Thai pregnant women. Meeprom, T., Ruanphoo, P., Bunyavejchevin, S., et al.[2023]

A study involving 96 pregnant women found that combining perineal massage with instrument-assisted perineal stretching using a short, repeated protocol significantly improved pelvic floor muscle (PFM) extensibility compared to using either technique alone.

While the combination technique enhanced extensibility, perineal massage alone was more effective in increasing PFM strength after eight sessions, highlighting the benefits of different techniques for various outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Perineal Massage and Instrument-Assisted Perineal Stretching With Short Protocol Effective for Increasing Pelvic Floor Muscle Extensibility? A Randomized Controlled Trial. Cabral, AL., de Freitas, SS., Pinto, RMC., et al.[2022]

Both instrument-assisted stretching and perineal massage significantly increased the extensibility of pelvic floor muscles (PFMs) in pregnant women, with no significant differences between the two methods.

Neither intervention affected the strength of the pelvic floor muscles, indicating that while extensibility improved, muscle strength remained unchanged after the treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of perineal preparation techniques on tissue extensibility and muscle strength: a pilot study. de Freitas, SS., Cabral, AL., de Melo Costa Pinto, R., et al.[2020]

The combination of perineal massage and warm compress (MassComp) did not significantly reduce the rates of perineal trauma requiring suturing compared to perineal massage alone in a study of 277 nulliparous women during the second stage of labor.

However, participants in the MassComp group reported higher satisfaction and were more likely to recommend the treatment to a friend, indicating a positive subjective experience despite no significant difference in clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined perineal massage and warm compress compared to massage alone during active second stage of labour in nulliparas: A randomised trial. Hong, JGS., Abdullah, N., Rajaratnam, RK., et al.[2022]

In a study of 300 women in active labor, perineal stretching greater than 150% was associated with a significantly higher rate of perineal repair needed after vaginal delivery (40.7% vs. 19.5%).

The findings suggest that excessive perineal stretching during the second stage of labor is a predictive factor for perineal damage, indicating that careful management of stretching may help reduce the need for episiotomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of spontaneous perineal stretching during delivery with perineal lacerations. Walfisch, A., Hallak, M., Harlev, S., et al.[2006]

Perineal massage during labor significantly reduces the risk of severe perineal trauma, such as third and fourth degree lacerations, with a relative risk of 0.49 based on a meta-analysis of nine trials involving 3374 women.

Women who received perineal massage were more likely to have an intact perineum and less likely to require an episiotomy, indicating additional benefits of this technique during vaginal delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineal massage during labor: a systematic review and meta-analysis of randomized controlled trials. Aquino, CI., Guida, M., Saccone, G., et al.[2020]

A systematic review of 16 studies involving 6487 subjects found that prenatal perineal massage significantly reduces the incidence of severe perineal tears (3-4 degree) during childbirth, with a relative risk reduction of 44%.

Prenatal perineal massage also lowers the risk of lateral perineal resection and long-term postpartum pain, indicating its potential benefits in preventing perineal injury and complications during and after delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Prenatal Perineal Massage on Postpartum Perineal Injury and Postpartum Complications: A Meta-Analysis. Chen, Q., Qiu, X., Fu, A., et al.[2022]

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