Soft Tissue Release With and Without Vaginal Dilators on Pain and Sexual Function in Genitio Pelvic Pain

Riphah International University

Status: Completed

Conditions: Genito-Pelvic Pain/Penetration Disorder

Treatments: Other: vaginal dilators; Other: soft tissue release

Study type: Interventional

Funder types: Other

Identifiers

NCT05857826

REC/RCR & AHS/23/0526

Details and patient eligibility

About

Study will be a randomized clinical trial which will incorporate two different interventions soft tissue release and vaginal dilators use would be administered to the women with genito pelvic pain. Subjects meeting the predetermined inclusion criteria will be divided into two groups using lottery method. Assessment will be done using GPPPD, Vancouver Visual Analogue Scale, female sexual function index and pelvic floor impact questionnaire. Subjects in one group will be treated with soft tissue release and vaginal dilators. And the other will be treated with soft tissue release only. Each subject will receive a total 09 treatment sessions, with 03 treatment sessions per week. Measurements will be recorded at baseline, 5th and 9th treatment session.

Full description

Painful sexual intercourse is a common female health problem. It is a complex disorder that often goes neglected. It can be further categorized into superficial or deep, and primary or secondary. Superficial is limited to the vulva or vaginal entrance, while deep means the extension of pain into the deeper parts of the vagina or lower pelvis. Deep dyspareunia is frequently associated with deep penetration. Primary pain initiates at the start of sexual intercourse, while in secondary, pain begins after some time of pain free sexual activity This study will be a randomized clinical trial which will incorporate two different interventions soft tissue release and vaginal dilators use would be administered to the women with genito pelvic pain. Subjects meeting the predetermined inclusion criteria will be divided into two groups using lottery method. Assessment will be done using GPPPD, Vancouver Visual Analogue Scale, female sexual function index and pelvic floor impact questionnaire . Subjects in one group will be treated with soft tissue release and vaginal dilators. And the other will be treated with soft tissue release only. Each subject will receive a total 09 treatment sessions, with 03 treatment sessions per week. Measurements will be recorded at baseline, 5th and 9th treatment session. Recorded values will be analyzed for any change using SPSS21.

Enrollment: 30 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women age 20 to 40 years
• Patient fulfilling DSM5 GPPPD criteria
• Pain in genitals before during or after intercourse
• Pain greater than 4 on a 10cm visual analogue scale

Exclusion criteria

• • History of pathological conditions like infections

  • Endometriosis
  • Tumors
  • Major psychiatric disorders
  • Painful bladder syndrome
  • Surgery of pelvic organs
  • Any ongoing treatment of genito pelvic pain.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

soft tissue release with vaginal dilators

Experimental group

Description:

Group A will receive soft tissue release with vaginal diltors. Soft tissue release consists of myofacial release and deep intervaginal massage.Triggers points can be released vaginally or rectally they are so painfyul on palpation deep massage of pelvic floor muscle

Treatment:

Other: vaginal dilators

Other: soft tissue release

soft tissue release only

Active Comparator group

Description:

will receive only soft tissue release using trigger point release vaginally or rectally and deep intervaginal massage

Treatment:

Other: soft tissue release