Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625001015437
Ethics application status
Approved
Date submitted
24/01/2025
Date registered
12/09/2025
Date last updated
12/09/2025
Date data sharing statement initially provided
12/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
EffIcacy of Intracavitary Manual Lymphatic Drainage as a Treatment for Vaginal Stenosis in Women With Sequelae of Post-Breast Cancer Treatment
Scientific title
EffIcacy of Intracavitary Manual Lymphatic Drainage as a Treatment for Vaginal Stenosis in Women With Sequelae of Post-Breast Cancer Treatment
Secondary ID [1] 313605 0
none
Universal Trial Number (UTN)
24/798-E
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vaginal stenosis 336448 0
breast cancer 338769 0
Condition category
Condition code
Cancer 332968 332968 0 0
Breast
Reproductive Health and Childbirth 335063 335063 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental group: Intracavitary Manual Lymphatic Drainage (IMLD) treatment.

The intervention in the experimental group will be carried out by a specialised physiotherapist. The treatment will consist of IMLD, one session per week lasting 20 minutes, for 8 weeks.

The patient will be placed in supine decubitus with hip flexion of 90o and knee flexion greater than 90o in both lower limbs. If the protocol is performed on a gynaecological examination couch, the patient is placed in the lithotomy position, the usual position for gynaecological examination, in which the patient is in the supine decubitus position, with 90o flexion of both coxofemoral joints and the knees, maintaining abduction of both lower limbs, with the possibility of support on leg supports or a heel stirrup, which allows the lower limbs to relax.
The physiotherapist is positioned on one side of the couch or in front of the patient in the case of the gynaecological examination couch.

The physiotherapist places his hand in neutral wrist flexion-extension and introduces his index finger and middle finger into the vaginal cavity, after lubrication with a gel, placing his forearm in neutral pronation-supination position. Once the fingers have been inserted approximately 5 centimetres into the vaginal cavity, a slow pronation movement of the forearm is performed. With this prior positioning of the patient and the physiotherapist, we begin the technique, the time for manual intracavitary and external genital lymphatic drainage will be 20 minutes.

Technique:

The IMLD technique is an adaptation of the resorption manoeuvre described by Leduc(138) to the anatomical area of application. The technique is performed with the index and middle finger, starting the manoeuvre from the proximal phalanx and pushing towards the distal phalanx, in the form of a blotting tampon.

The approach areas are the posterior wall of the vagina, and both lateral walls, repeating the manoeuvre on each wall several times.
The purpose of this manoeuvre is to reduce oedema and vulvar congestion, draining the lymphatic load in the direction of the inguinal and external iliac nodes.
Once the intracavitary treatment has been completed, we will perform a Manual Lymphatic Drainage (MLD) on the external genitalia, supra pubic and inguinal areas, carrying out the following manoeuvres:
- Vodder's fixed circles
- Classic Leduc resorption

To assess adherence to the intervention, several strategies will be employed. Attendance will be recorded at each treatment session, and participants will be asked to sign a session log. In addition, medical records will be reviewed to verify relevant clinical history and continuity of care. Personalized follow-up will be conducted, either in person or by phone, to reinforce adherence and identify any potential barriers. Any incidents, missed sessions, or changes in the treatment plan will be documented by the treating physiotherapist.
The technique used will be Intracavitary IMLD, specifically applied via the vaginal route. The maneuver will consist of gentle, rhythmic, and slow manual mobilizations within the vaginal canal, following the physiological direction of lymphatic flow toward the inguinal lymph nodes. The intervention will be performed exclusively by physiotherapists specialized in pelvic floor rehabilitation and lymphatic drainage. The specific application of the technique, including intensity, duration, and frequency, will be tailored to each patient based on clinical evaluation, the degree of vaginal stenosis, and always under medical indication and consent, in coordination with the oncology and gynecology teams.
Intervention code [1] 330399 0
Treatment: Other
Intervention code [2] 331904 0
Treatment: Devices
Comparator / control treatment
Control group: Treatment using dilators.

The treatment in the control group will be carried out using dilators at home. The treatment will last for 8 weeks, lasting 20 minutes.

There are four sizes of dilators that differ in length and diameter. The lengths vary from the smallest dilator (85mm), to the second (105mm), to the third (135mm) and up to the fourth and largest of 160mm. The same applies to the diameter, which starts at 22mm and increases progressively from 27mm, through 32mm and up to 37mm.

Each week, a dilator selection assessment will be performed. How to use the dilator will be explained and the subjects themselves will have to perform the technique at home.

The treatment will consist of inserting the dilators themselves, only inserting the dilator and keeping it in the vagina for 20 minutes. Eight sessions will be carried out once a week.
Control group
Active

Outcomes
Primary outcome [1] 340506 0
PAIN
Timepoint [1] 340506 0
Pre-treatment and immediately post-treatment
Secondary outcome [1] 444299 0
Biomechanics and viscoelastic properties such as muscle tone (Hz)
Timepoint [1] 444299 0
Pre-treatment and immediately post-treatment
Secondary outcome [2] 452051 0
Dynamic Stiffness (N/m)
Timepoint [2] 452051 0
Pre-treatment and immediately post-treatment
Secondary outcome [3] 452052 0
Mechanical Stress Relaxation Time (ms)
Timepoint [3] 452052 0
Pre-treatment and immediately post-treatment

Eligibility
Key inclusion criteria
Inclusion criteria
- Women aged between 18 and 65 years.
- Breast cancer patients diagnosed with treatment-related vaginal stenosis.
- Patients who have received QT/RT/BT treatment in the past.
- Patients with and without hormone suppressor treatment.
- Signed informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

- Patients who do not accept intracavitary treatment.
- Patients with abdominopelvic surgical treatment prior to the oncological process.
- Patients diagnosed with dyspareunia prior to cancer.
- Patients with vaginal narrowing prior to cancer.
- Patients with menopause at the time of cancer diagnosis.
- Pregnant women.
- Patients with decompensated heart disease.
- Untreated malignant cancer
- Acute infection
- Acute (uncontrolled) allergy.
- Medical diagnosis of endometriosis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be ensured so that the person assigning participants to study groups cannot predict or know the upcoming assignment. Additionally, outcome assessors will be blinded to the participants’ group allocation (intervention or control) in order to ensure unbiased evaluation and minimize the risk of bias during data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number´s list will be generated by the program Python.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive Phase: where we will proceed to summarise all the characteristics of each patient in measures of central tendency and dispersion (or percentages). Inferential phase: this will be carried out by means of: Point estimation and 95% confidence intervals of the difference or degree of improvement in dyspareunia and vaginal stenosis in the two groups before and after the application of the treatment. And contrasts after the therapeutic intervention between the two groups. Finally, writing up the results and Publication Phase.

The statistical analysis will be divided into three phases. First, in the descriptive phase, we will summarize the characteristics of each participant using measures of central tendency and dispersion, or percentages where appropriate. In the inferential phase, we will conduct (A) point estimation and calculate 95% confidence intervals to assess differences or improvements in dyspareunia and vaginal stenosis between the two groups, before and after the intervention, and (B) perform hypothesis testing to compare post-treatment outcomes between the experimental and control groups. Finally, in the results and publication phase, findings will be interpreted and disseminated.
The sample size calculation was performed using the G*Power 3.1 software developed by Heinrich Heine University Düsseldorf. We assumed a significance level of 5% (a = 0.05), a power of 80% (1-ß = 0.80), and a two-tailed test. The minimally clinically important difference (MCID) for the Visual Analogue Scale (VAS) was set at 11 mm, based on values reported in the literature ranging from 9 to 13 mm. Assuming a standard deviation of 15 mm and accounting for a 15% dropout rate, the required sample size was determined to be 35 participants per group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/10/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 26842 0
Spain
State/province [1] 26842 0

Funding & Sponsors
Funding source category [1] 318276 0
University
Name [1] 318276 0
Universidad europea de Madrid
Country [1] 318276 0
Spain
Primary sponsor type
Individual
Name
Isabel Mínguez Esteban - Universidad Europea de Madrid
Address
Country
Spain
Secondary sponsor category [1] 320430 0
Individual
Name [1] 320430 0
Vanesa Abuin Porras - Universidad Europea de Madrid
Address [1] 320430 0
Country [1] 320430 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316723 0
Hospital Clínico San Carlos
Ethics committee address [1] 316723 0
Ethics committee country [1] 316723 0
Spain
Date submitted for ethics approval [1] 316723 0
22/11/2024
Approval date [1] 316723 0
09/01/2025
Ethics approval number [1] 316723 0
Ethics committee name [2] 316918 0
Hospital Clinico San Carlos
Ethics committee address [2] 316918 0
Ethics committee country [2] 316918 0
Spain
Date submitted for ethics approval [2] 316918 0
22/11/2024
Approval date [2] 316918 0
09/01/2025
Ethics approval number [2] 316918 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138794 0
Mrs Isabel Mínguez Estebam
Address 138794 0
Universidad Europea de Madrid, S.A.U. Calle Tajo, s/n – Urbanización El Bosque 28670 Villaviciosa de Odón (Madrid), España
Country 138794 0
Spain
Phone 138794 0
+34 619121101
Fax 138794 0
Email 138794 0
[email protected]
Contact person for public queries
Name 138795 0
Isabel Minguez esteban
Address 138795 0
Universidad Europea de Madrid, S.A.U. Calle Tajo, s/n – Urbanización El Bosque 28670 Villaviciosa de Odón (Madrid), España
Country 138795 0
Spain
Phone 138795 0
+34 619121101
Fax 138795 0
Email 138795 0
[email protected]
Contact person for scientific queries
Name 138796 0
Isabel Mínguez Estebam
Address 138796 0
Universidad Europea de Madrid, S.A.U. Calle Tajo, s/n – Urbanización El Bosque 28670 Villaviciosa de Odón (Madrid), España
Country 138796 0
Spain
Phone 138796 0
+34 619121101
Fax 138796 0
Email 138796 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.