Dyspareunia (Female)
Conditions
Keywords
dyspareunia,
Brief summary
Transcutaneous electrical acupoint stimulation (TEAS)was proven to stimulate the secretion of endogenous opioid peptides which are partial substitutes for the exogenous opioids stimulated by drugs in the central nervous system and can thus relieve pain. Till now there is no previous study that investigates the effect of TEAS on dyspareunia. This study will determine the effect of transcutaneous acupoint stimulation on dyspareunia. Patients will be divided randomly into two groups equal in number: The control group will receive only topical medication. The study group will receive Acu-TENS and topical medication.
Detailed description
Patients will be divided randomly into two groups equal in number: Control group (Group A): It will include 19 women with dyspareunia. They will receive only topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity). Study group (GroupB): It will include 19 women with dyspareunia. They will receive Acu-TENS (30 minutes per session, once per week for 10 weeks), and topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity). All females will be given a full explanation of the study protocol and a consent form will be signed by each female before participating in the study
Interventions
OTHERTopical medication
It will be given to all participants in both groups (A&B). The most commonly prescribed topical medication is lidocaine ointment 5% (Xylocaine jelly 2% or ointment 5%; AstraZeneca Pharmaceuticals LP, Wilmington, DE), applied as required for symptoms and for 30 minutes before sexual activity.
OTHERTranscutaneous electrical acupoint stimulation
This procedure will be applied for group B only. Before starting the first treatment session, each patient will be instructed briefly about the nature of the treatment to gain the patient's confidence and cooperation. This procedure will be performed by using TENS device on acupoints as the following: The participating woman will be placed in a relaxed comfortable supine position with her back well supported. The surface of the treated skin and the electrodes will be cleaned with alcohol wipe. The TENS protocol consists of a 30-minute weekly. session for 10 weeks of biphasic pulses with modulation 0/10-50 Hz of frequency and 300/100/3000 microseconds of pulse duration (s). The intensity parameter will be adapted individually according to each woman's perception, and modulated so that it is applied without discomfort, ranging between 10 and 100 mA (pulsing sensation) (Dionisi and Senatori ,2011)
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: * Women complain of secondary dyspareunia, diagnosed and referred by the gynecologist. * Multiparous women. * Their ages will range from 25-35 years. * Their body BMI will be less than 35 kg/m². * Their pain level on the VAS will be ≥ 4. * All the women were negative for vaginal infections caused by viruses, bacteria or fungi. *
Exclusion criteria
* Pregnancy * Malignancy. * The presence of an intrauterine device, vaginal infection, or skin/mucous lesions. * Diabetes mellitus. * Dermatological abnormalities on the skin at acupuncture point. * Severe uncontrolled cardiac patients or implanted cardiac rhythm devices. * Dyspareunia with endometriosis. * Fearing from electricity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of pain intensity | Ten weeks | Visual analogue scale (VAS) will be used to measure pain intensity for each female in both groups (A&B). Each female will be asked to mark the point on the scale that represents her pain level. |
| Assessment of dyspareunia | 10 Weeks | Marinoff Dyspareunia Scale will be used to evaluate vaginal and vulvar symptoms and pain related to sexual intercourse for both groups (A& B) before and after the end of the treatment (10 weeks). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of sexual function | Ten weeks | The female sexual function index will be used to evaluate sexual function including (desire, arousal, lubrication, satisfaction, and orgasm) for all women with dyspareunia in both groups (A& B) before and after the end of the treatment. |
| Assessment of quality of life | Ten weeks | Sexual quality of life-female (SQOL-F) questionnaire will be used to evaluate quality of life for all women with dyspareunia in both groups (A&B) before and after the end of the treatment. |
Countries
Egypt
Contacts
Primary ContactMarwa GA Ahmed
Backup ContactManal A El-Shafei
Outcome results
None listed