Prolapse, VaginalNCT06416982
Perineal Massage for Pessary Examinations
A study testing Perineal massage in people with Prolapse, Vaginal and Stress Urinary Incontinence, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prolapse, Vaginal, Stress Urinary Incontinence, Pessaries
- What is being tested?
- Perineal massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 1 Apr 2026
- Phase
- Interventional
- 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
- Undergoing routine pessary management by office providers
- 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
Who cannot join
- Non-English speaking
- Found to have a condition such as significant vaginal erosion that precludes replacement of pessary after exam
- Unable to undergo massage due to functional or cognitive impediments or significant discomfort during massage
- Regular usage of pain medications for prior pessary checks such as lidocaine, and unwilling to forgo lidocaine for two study visits
- Pessary visit for pain, pessary expulsion, or significant bleeding, as per provider's judgement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perineal Massage for Increased Comfort During Pessary Examinations: a Cross-over Randomized Controlled 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.
Read more
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.
- Conditions
- Prolapse, Vaginal, Stress Urinary Incontinence, Pessaries, Pain
- Being tested
- Perineal massage
- Keywords
- Pessaries, Vaginal prolapse, Stress urinary incontinence, Pain, Conservative management, Perineal massage
- Medical subject headings
- Uterine Prolapse, Urinary Incontinence, Stress, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal massageOther
2 minutes of perineal massage as described in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Perineal massage before pessary examination | Experimental | 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. Receives: Other: Perineal massage |
| No perineal massage before pessary examination | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-perceived pain
Change in pain scores during pessary check (removal and replacement) compared to baseline pain score prior to pessary check using a visual analog scale (VAS) pain scale, as reported by the participant. The VAS pain scale is a validated scale that is performed by having the participant place a mark on a 10 cm line from 0 to 10 to indicate severity of pain. 0 indicates no pain, 10 indicates the most severe pain. Distance from 0 to the mark is measured and recorded in millimeters.
Measured: 3 months
Secondary outcomes (5)
Patient satisfaction with perineal massage
Participants will be asked to rate satisfaction with perineal massage on a 5-point Likert scale. The 5-point Likert scale is a psychometric response method where respondents can easily answer questions and state their level of agreement in five points. The 5-point Likert scale consists of the below points: (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree.
Measured: 3 months
Patient preference for future perineal massage
Participants will be asked whether they would choose to undergo perineal massage during future visits. Allowed responses will be Yes/No.
Measured: 3 months
Provider-perceived patient discomfort
The provider performing the pessary examination will be asked to rate patient pain before and during the pessary examination (pessary removal and replacement) on a VAS pain scale. The change in pain score during the pessary examination will be compared. The VAS pain scale is a validated scale that is performed by having the provider place a mark on a 10 cm line from 0 to 10 to indicate severity of pain. 0 indicates no pain, 10 indicates the most severe pain. Distance from 0 to the mark is measured and recorded in millimeters.
Measured: 3 months
Provider-perceived ease of pessary removal
Providers will evaluate ease of pessary removal on a scale of 1 to 10 (with 10 being the most difficult). The ease of pessary removal at the time of the intervention visit will be compared.
Measured: 3 months
Perineal and vaginal abrasion
Providers will be asked to note the presence of any perineal or vaginal abrasions that are thought to be due to pessary removal and/or replacement. The proportion of participants who sustain a perineal or vaginal abrasion will be compared.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Aug 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse, VaginalStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Chu, MD, MSCI, Principal investigator, University of North Carollina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416982
- Sponsor's protocol ID
- 24-0544
- Status last verified
- Mar 2026
- First submitted
- 13 May 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineal Massage for Increased Comfort During Pessary Examinations: a Cross-over Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06416982
- Acronym / sponsor ID
- 24-0544
- Conditions
- Prolapse, Vaginal, Stress Urinary Incontinence, Pessaries, Pain
- Keywords
- Pessaries, Vaginal prolapse, Stress urinary incontinence, Pain, Conservative management, Perineal massage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 16 May 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineal massage before pessary examination | Experimental | Other: Perineal massageParticipant 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. |
| No perineal massage before pessary examination | No 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing routine pessary management by office providers
- 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
Key exclusion criteria (5 listed)
- Non-English speaking
- Found to have a condition such as significant vaginal erosion that precludes replacement of pessary after exam
- Unable to undergo massage due to functional or cognitive impediments or significant discomfort during massage
- Regular usage of pain medications for prior pessary checks such as lidocaine, and unwilling to forgo lidocaine for two study visits
- Pessary visit for pain, pessary expulsion, or significant bleeding, as per provider's judgement
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 massage2 minutes of perineal massage as described in arm/group descriptions. | Other | Perineal massage before pessary examination |
Primary outcome
Patient-perceived pain
Time frame: 3 months
Change in pain scores during pessary check (removal and replacement) compared to baseline pain score prior to pessary check using a visual analog scale (VAS) pain scale, as reported by the participant. The VAS pain scale is a validated scale that is performed by having the participant place a mark on a 10 cm line from 0 to 10 to indicate severity of pain. 0 indicates no pain, 10 indicates the most severe pain. Distance from 0 to the mark is measured and recorded in millimeters.
5 secondary outcomes
Patient satisfaction with perineal massage
Time frame: 3 months
Patient preference for future perineal massage
Time frame: 3 months
Provider-perceived patient discomfort
Time frame: 3 months
Provider-perceived ease of pessary removal
Time frame: 3 months
Perineal and vaginal abrasion
Time frame: 3 months
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 20 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. This study is not recruiting at the moment.
Christine Chu, MD, MSCI principal investigator
University of North Carollina at Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal massage in people with Prolapse, Vaginal and Stress Urinary Incontinence, run by University of North Carolina, Chapel Hill 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-perceived pain (time frame: 3 months). 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 20 Mar 2026.