Genito-Pelvic Pain/Penetration Disorder Clinical Trial
Official title:
Effects of Soft Tissue Release With and Without Vaginal Dilators on Pain and Sexual Function in Women With Genito Pelvic Pain
Verified date | March 2024 |
Source | Riphah International University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 15, 2023 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Lahore general hospital | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
Riphah International University |
Pakistan,
Antosh DD, Gutman RE, Park AJ, Sokol AI, Peterson JL, Kingsberg SA, Iglesia CB. Vaginal dilators for prevention of dyspareunia after prolapse surgery: a randomized controlled trial. Obstet Gynecol. 2013 Jun;121(6):1273-1280. doi: 10.1097/AOG.0b013e3182932ce2. — View Citation
Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025. — View Citation
Both S, Brauer M, Weijenborg P, Laan E. Effects of Aversive Classical Conditioning on Sexual Response in Women With Dyspareunia and Sexually Functional Controls. J Sex Med. 2017 May;14(5):687-701. doi: 10.1016/j.jsxm.2017.03.244. Epub 2017 Mar 31. — View Citation
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Ghaderi F, Bastani P, Hajebrahimi S, Jafarabadi MA, Berghmans B. Pelvic floor rehabilitation in the treatment of women with dyspareunia: a randomized controlled clinical trial. Int Urogynecol J. 2019 Nov;30(11):1849-1855. doi: 10.1007/s00192-019-04019-3. Epub 2019 Jul 8. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Female sexual function index | The Female Sexual Function Index (FSFI) is a very well-worded sexual function screen with excellent psychometric qualities. However, some aspects of the scoring procedures pose conceptual and statistical problems, which we illustrate in part by way of an empirical example. The recommended solutions should further strengthen the utility and validity of this instrument | up to 3 weeks | |
Primary | Visual analogue scale | Describes the construction of visual analogue scale that could be used with critically ill patients, the structural and visual cues on this VAS allow for exact placement of the template and reliable measurements. Rates pain from 1 to 10. | up to 3 weeks | |
Primary | Pelvic floor impact questionnaire | The Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire-7 are valid, reliable, and responsive short forms of 2 condition-specific quality-of-life questionnaires for women with pelvic floor disorders | up to 3 weeks |
Status | Clinical Trial | Phase | |
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Completed |
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N/A | |
Terminated |
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Phase 2 |