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

Trial Summary

What is the purpose of this trial?

Pessaries are effective non-surgical devices for reduction of prolapse. However, use of pessaries are limited in some women due to patient discomfort. While lidocaine can be used to improve pessary checks, its use may be limited due to supply chain shortages, lack of insurance coverage, and optimization of resource utilization. More techniques to improve pessary examination comfort are needed. Perineal massage prior to delivery and at the time of active labor has been noted to reduce perineal trauma and perineal discomfort, theoretically by desensitizing the nerve endings in the skin, broadening the vaginal opening, and increasing elasticity of the perineal tissue. Since most discomfort with pessary checks is during removal and insertion through the vaginal introitus, perineal massage may be a beneficial technique that women could potentially learn to improve comfort with pessary checks. The objective of this study is to examine the effectiveness of perineal massage prior to pessary check in improving comfort of pessary checks for patients using a cross-over randomized controlled trial. Patients who follow up for pessary checks with the division of Urogynecology at UNC will be approached about participating in this study. The study will involve two clinical visits. At the first visit, the patient will be randomized to 2 minutes of perineal massage with water based gel of 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; versus application of gel to the internal vagina and external vagina without massage. Providers will be blinded to randomization and proceed with pessary check as per normal clinical protocols. Patients will rate self-reported pain before, during pessary check, and after the pessary check on a VAS scale; and rate whether they would prefer to repeat this method at future visits via Likert scale. Healthcare professionals will also rate perceived patient pain on VAS scale; ease of pessary removal; and note any perineal or introital laceration or abrasion that may occur during the pessary fitting. At the following visit, patients will be assigned to the group to which they were not initially randomized. Patients and healthcare professionals will again rate pain as described above. Patients will also rank preference for perineal massage using PGI-I.

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 data supports the effectiveness of the treatment Perineal Massage, Perineal Stretching, Vaginal Massage for prolapse?

Research shows that perineal massage during labor can significantly reduce the risk of severe perineal trauma, such as tears, and increase the chances of having an intact perineum. This suggests that similar techniques might help improve tissue flexibility and strength, which could be beneficial for conditions like prolapse. ^{1 2 3 4 5}

Is perineal massage safe for humans?

Research suggests that perineal massage is generally safe for humans, as it has been shown to reduce the risk of severe perineal trauma during childbirth without significant adverse effects. ^{2 5 6 7 8}

How does the treatment of perineal massage for prolapse differ from other treatments?

Perineal massage for prolapse is unique because it involves manually stretching and massaging the perineal area to increase the flexibility and strength of pelvic floor muscles, which is different from other treatments that may not focus on physical manipulation of the tissues. This approach is similar to techniques used to reduce perineal tears during childbirth, but its application for prolapse is novel. ^{2 3 4 5 9}

Research Team

Christine Chu, MD, MSCI

Principal Investigator

University of North Carollina at Chapel Hill

Eligibility Criteria

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

I am currently receiving pessary care from my healthcare provider.

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

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.

I do not speak English.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Prenatal Perineal Massage on Postpartum Perineal Injury and Postpartum Complications: A Meta-Analysis. [2022]

2. Ireland 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. [2022]

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effects of perineal preparation techniques on tissue extensibility and muscle strength: a pilot study. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Perineal massage during labor: a systematic review and meta-analysis of randomized controlled trials. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Prevention of perineal trauma by perineal massage during pregnancy: a pilot study. [2019]

7. Spain pubmed.ncbi.nlm.nih.gov

[Update on the effectiveness and evidence of ante-natal perineal massage]. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Knowledge, attitude and acceptability regarding antenatal perineal massage in Thai pregnant women. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Association of spontaneous perineal stretching during delivery with perineal lacerations. [2006]