## Protocol Section
### Identification Module
**NCT ID:** NCT06416982

**Brief Title:** Perineal Massage for Pessary Examinations

**Official Title:** Perineal Massage for Increased Comfort During Pessary Examinations: a Cross-over Randomized Controlled Trial

#### Organization Study ID Info
**ID:** 24-0544
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of North Carolina, Chapel Hill

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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 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.

### Conditions Module

**Conditions:**

- Prolapse, Vaginal

- Stress Urinary Incontinence

- Pessaries

- Pain

**Keywords:**

- Pessaries

- Vaginal prolapse

- Stress urinary incontinence

- Pain

- Conservative management

- Perineal massage

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Participants will be randomized to intervention vs no intervention at the first visit without stratification, then will undergo the opposite intervention at the second visit. While participants cannot be blinded to the intervention, providers performing the pessary checks and providing provider-perceived pain scores will be blinded to the intervention as someone on the research team other than the provider will perform the intervention prior to the pessary check. If there is unexpected breaking of the blind (e.g. participant tells provider which intervention was performed), the provider will report this to the research team and this will be noted in the study results.

**Who Masked:**

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 68

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Perineal massage

**Label:** Perineal massage before pessary examination

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Label:** No perineal massage before pessary examination

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Perineal massage before pessary examination

**Description:** 2 minutes of perineal massage as described in arm/group descriptions.

**Name:** Perineal massage

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** Participants will be asked rate discomfort during the perineal massage on a VAS pain scale.

**Measure:** Patient discomfort during perineal massage

**Time Frame:** At the 3 month follow up visit

#### Primary Outcomes

**Description:** 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.

**Measure:** Patient-perceived pain

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Patient satisfaction with perineal massage

**Time Frame:** 3 months

**Description:** Participants will be asked whether they would choose to undergo perineal massage during future visits. Allowed responses will be Yes/No.

**Measure:** Patient preference for future perineal massage

**Time Frame:** 3 months

**Description:** 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.

**Measure:** Provider-perceived patient discomfort

**Time Frame:** 3 months

**Description:** 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.

**Measure:** Provider-perceived ease of pessary removal

**Time Frame:** 3 months

**Description:** 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.

**Measure:** Perineal and vaginal abrasion

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** christine_chu@med.unc.edu

**Name:** Christine Chu, MD, MSCI

**Phone:** 9849740496

**Role:** CONTACT

**Contact 2:**

**Email:** rodney_stephenson@med.unc.edu

**Name:** Rodney Stephenson

**Phone:** 919-966-4717

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Raleigh

**Country:** United States

**Facility:** UNC Urogynecology

**State:** North Carolina

**Zip:** 27607

#### Overall Officials

**Official 1:**

**Affiliation:** University of North Carollina at Chapel Hill

**Name:** Christine Chu, MD, MSCI

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014555

- Term: Urination Disorders

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000059411

- Term: Lower Urinary Tract Symptoms

- ID: D000020924

- Term: Urological Manifestations

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000019960

- Term: Elimination Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000014591

- Term: Uterine Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000091662

- Term: Genital Diseases

- ID: D000056887

- Term: Pelvic Organ Prolapse

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14261

- Name: Prolapse

- Relevance: HIGH

- As Found: Prolapse

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M17299

- Name: Urinary Incontinence

- Relevance: HIGH

- As Found: Urinary Incontinence

- ID: M7936

- Name: Enuresis

- Relevance: HIGH

- As Found: Urinary Incontinence

- ID: M17300

- Name: Urinary Incontinence, Stress

- Relevance: HIGH

- As Found: Stress Urinary Incontinence

- ID: M27171

- Name: Nocturnal Enuresis

- Relevance: LOW

- As Found: Unknown

- ID: M17344

- Name: Uterine Prolapse

- Relevance: HIGH

- As Found: Prolapse, Vaginal

- ID: M17305

- Name: Urination Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M29464

- Name: Lower Urinary Tract Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M22659

- Name: Urological Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M21832

- Name: Elimination Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M28618

- Name: Pelvic Organ Prolapse

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014549

- Term: Urinary Incontinence

- ID: D000004775

- Term: Enuresis

- ID: D000014550

- Term: Urinary Incontinence, Stress

- ID: D000014596

- Term: Uterine Prolapse

- ID: D000011391

- Term: Prolapse

### Misc Info Module

- Version Holder: 2024-05-31
