VaginismusNCT06486896
Effect of Adding Interferential Current to Pelvic Floor Muscle Training on Vaginismus
A study testing Pelvic floor training, Interferential current and General advice in people with Vaginismus, run by Cairo University.
Trial summary
This study aims to determine the effect of adding interferential current to pelvic floor muscle training on vaginismus. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Vaginismus
- What is being tested?
- Pelvic floor training, Interferential current and General advice
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2024to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women suffer from primary vaginismus with a duration of marriage ranging from 1 to 12 months. They are diagnosed and referred by the gynecologist.
- Their pain level is ≥ 4 on the visual analogue scale.
- They have a sedentary lifestyle.
Who cannot join
- Vaginismus requiring surgical treatment.
- Any gynecological diseases such as pelvic organ prolapse, vulvar vestibulitis, vulvar pain, clitorodynia, vulvar dysesthesia, or any pelvic inflammatory diseases.
- Lower urinary tract infection.
- Husband with sexual dysfunction that prevents penetration.
- Diseases involving nerves and muscles, such as myasthenia gravis.
- Severe psychiatric disorder or cognitive relegation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Adding Interferential Current to Pelvic Floor Muscle Training on Vaginismus: A Randomized Controlled Trial
This study aims to determine the effect of adding interferential current to pelvic floor muscle training on vaginismus.
Read the detailed description
Vaginismus is a common sexual problem with a prevalence of 20% in Egyptian women, that has a significant impact on a person's life, affecting their physical, emotional, and psychological well-being, as well as their relationships and overall quality of life.
There were previous studies that studied the effect of pelvic floor rehabilitation on vaginismus and found that there was a highly significant decrease in pain and pelvic floor muscle spasms, as well as a highly significant increase in sexual function. Also, only one previous protocol explored the effect of interferential current on treating vaginismus. But, till now, there is no prior study that investigated the impact of adding interferential current to pelvic floor muscle training on treating vaginismus. this trial has two groups; one will receive interferential current, and the other group will receive interferential current + pelvic floor muscle training
- Conditions
- Vaginismus
- Being tested
- Pelvic floor training, Interferential current, General advice
- Keywords
- Interferential, pelvic floor training, vaginismus
- Medical subject headings
- Vaginismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor trainingOther
It will be in the form of pelvic floor relaxation with biofeedback, as well as stretching exercises for the pelvic floor and the adjacent muscles. The patient will be asked to lie in a comfortable crock lying position. She will be instructed to do diaphragmatic breathing exercises. The vaginal electrode of the biofeedback will be gently introduced into the vagina to start pelvic floor relaxation training. Then, the patient will be asked to perform pelvic floor relaxation by slightly contracting the pubococcygeus muscle. After 10 minutes of pelvic floor relaxation training, the patient will then be instructed to return to the active state gradually, the treatment procedure will be performed 3 times/ week for 8 weeks. Stretching exercises for the pelvic floor and the adjacent muscles: Levator ani \& perineal muscles stretch, hip adductor muscles stretch, piriform muscle stretch, hip flexor muscles stretch, and obturator internus muscle stretch.
Interferential currentDevice
Each female in the experimental group will receive interferential current, 3o minutes per session, 2 sessions per week, for 8 weeks. The applied parameters will be a frequency of 2000Hz, a modulated amplitude of frequency of 80Hz, pulse width of 200μs, and the intensity is modulated according to the sensory level of each participant. While the participant is in a comfortable crock lying position with abducted hips, the position of the electrodes will be maintained in all sessions
General adviceBehavioural
The patients in both groups will follow general advice to help vaginismus for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor training | Active comparator | The patients will receive pelvic floor training exercise+ advice 3 times/weekly for 8 weeks Receives: Other: Pelvic floor training; Behavioral: General advice |
| Interferential current | Experimental | Patients will receive interferential current+pelvic floor training+advice Receives: Other: Pelvic floor training; Device: Interferential current; Behavioral: General advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain intensity.
The visual analogue scale (VAS): will be used to measure pain intensity for each woman in both groups. Each woman will be asked to mark the point on the scale that represents her pain level.
Measured: Eight weeks
Quantification of pressure pain threshold in the perineum.
The pressure pain threshold in the perineum region will be evaluated with a pressure algometer.
Measured: Eight weeks
Assessment of pelvic floor muscle tone.
It will be assessed by biofeedback perineometer.
Measured: Eight weeks
Secondary outcomes (1)
Measurement of cognition regarding vaginal penetration in women with lifelong vaginismus.
The Vaginal Penetration Cognition Scale (VPCQ) will be used to evaluate cognition regarding to vaginal penetration for all participants in both groups before and after the end of the treatment program.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start20 Jul 2024 (estimated)
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginismusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana, Cairo University
- Investigators
- Doaa A. Osman, PHD, Study chair, Department of Women's Health, Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486896
- Sponsor's protocol ID
- P.T.REC/012/004953
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Interferential Current to Pelvic Floor Muscle Training on Vaginismus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06486896
- Acronym / sponsor ID
- P.T.REC/012/004953
- Conditions
- Vaginismus
- Keywords
- Interferential, pelvic floor training, vaginismus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jul 2024 (estimated)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 5 Jul 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.
This study aims to determine the effect of adding interferential current to pelvic floor muscle training on vaginismus.
Detailed description
Vaginismus is a common sexual problem with a prevalence of 20% in Egyptian women, that has a significant impact on a person's life, affecting their physical, emotional, and psychological well-being, as well as their relationships and overall quality of life.
There were previous studies that studied the effect of pelvic floor rehabilitation on vaginismus and found that there was a highly significant decrease in pain and pelvic floor muscle spasms, as well as a highly significant increase in sexual function. Also, only one previous protocol explored the effect of interferential current on treating vaginismus. But, till now, there is no prior study that investigated the impact of adding interferential current to pelvic floor muscle training on treating vaginismus. this trial has two groups; one will receive interferential current, and the other group will receive interferential current + pelvic floor muscle training
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor training | Active comparator | Other: Pelvic floor training, Behavioral: General adviceThe patients will receive pelvic floor training exercise+ advice 3 times/weekly for 8 weeks |
| Interferential current | Experimental | Other: Pelvic floor training, Device: Interferential current, Behavioral: General advicePatients will receive interferential current+pelvic floor training+advice |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women suffer from primary vaginismus with a duration of marriage ranging from 1 to 12 months. They are diagnosed and referred by the gynecologist.
- Their pain level is ≥ 4 on the visual analogue scale.
- They have a sedentary lifestyle.
Key exclusion criteria (6 listed)
- Vaginismus requiring surgical treatment.
- Any gynecological diseases such as pelvic organ prolapse, vulvar vestibulitis, vulvar pain, clitorodynia, vulvar dysesthesia, or any pelvic inflammatory diseases.
- Lower urinary tract infection.
- Husband with sexual dysfunction that prevents penetration.
- Diseases involving nerves and muscles, such as myasthenia gravis.
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 |
|---|---|---|
| Pelvic floor trainingIt will be in the form of pelvic floor relaxation with biofeedback, as well as stretching exercises for the pelvic floor and the adjacent muscles. The patient will be asked to lie in a comfortable crock lying position. She will be instructed to do diaphragmatic breathing exercises. The vaginal electrode of the biofeedback will be gently introduced into the vagina to start pelvic floor relaxation training. Then, the patient will be asked to perform pelvic floor relaxation by slightly contracting the pubococcygeus muscle. After 10 minutes of pelvic floor relaxation training, the patient will then be instructed to return to the active state gradually, the treatment procedure will be performed 3 times/ week for 8 weeks. Stretching exercises for the pelvic floor and the adjacent muscles: Levator ani \& perineal muscles stretch, hip adductor muscles stretch, piriform muscle stretch, hip flexor muscles stretch, and obturator internus muscle stretch. | Other | Interferential current, Pelvic floor training |
| Interferential currentEach female in the experimental group will receive interferential current, 3o minutes per session, 2 sessions per week, for 8 weeks. The applied parameters will be a frequency of 2000Hz, a modulated amplitude of frequency of 80Hz, pulse width of 200μs, and the intensity is modulated according to the sensory level of each participant. While the participant is in a comfortable crock lying position with abducted hips, the position of the electrodes will be maintained in all sessions | Device | Interferential current |
| General adviceThe patients in both groups will follow general advice to help vaginismus for 8 weeks | Behavioural | Interferential current, Pelvic floor training |
Primary outcome
Assessment of pain intensity.
Time frame: Eight weeks
The visual analogue scale (VAS): will be used to measure pain intensity for each woman in both groups. Each woman will be asked to mark the point on the scale that represents her pain level.
Quantification of pressure pain threshold in the perineum.
Time frame: Eight weeks
The pressure pain threshold in the perineum region will be evaluated with a pressure algometer.
Assessment of pelvic floor muscle tone.
Time frame: Eight weeks
It will be assessed by biofeedback perineometer.
1 secondary outcome
Measurement of cognition regarding vaginal penetration in women with lifelong vaginismus.
Time frame: Eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
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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.
Doaa A. Osman, PHD study chair
Department of Women's Health, Faculty of Physical Therapy, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor training, Interferential current and General advice in people with Vaginismus, run by Cairo University.
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 6 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: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana Zaky, Student (01102628352, Ranazaky1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain intensity. (time frame: Eight weeks). The study lists 3 primary outcomes in all. 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 5 Jul 2024.