search
Back to results

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

Primary Purpose

Genito-Pelvic Pain/Penetration Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
soft tissue release
vaginal dilators
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genito-Pelvic Pain/Penetration Disorder

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Lahore general hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

soft tissue release with vaginal dilators

soft tissue release only

Arm 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

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

Outcomes

Primary Outcome Measures

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
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.
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

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
May 4, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05857826
Brief Title
Soft Tissue Release With and Without Vaginal Dilators on Pain and Sexual Function in Genitio Pelvic Pain
Official Title
Effects of Soft Tissue Release With and Without Vaginal Dilators on Pain and Sexual Function in Women With Genito Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genito-Pelvic Pain/Penetration Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
soft tissue release with vaginal dilators
Arm Type
Experimental
Arm 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
Arm Title
soft tissue release only
Arm Type
Active Comparator
Arm Description
will receive only soft tissue release using trigger point release vaginally or rectally and deep intervaginal massage
Intervention Type
Other
Intervention Name(s)
soft tissue release
Intervention Description
Patient will be asked to lie in hook lying position using a clean glove will apply some water based lubricant gently sweep vaginal muscle from superficial to deep until find a trigger point press it and release it using circle motion for 1 to 2 minute until the trigger point is completely released.
Intervention Type
Other
Intervention Name(s)
vaginal dilators
Intervention Description
Vaginal dilators will be used according to the patient's condition starting from small sizes to the wider ones.
Primary Outcome Measure Information:
Title
Female sexual function index
Description
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
Time Frame
up to 3 weeks
Title
Visual analogue scale
Description
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.
Time Frame
up to 3 weeks
Title
Pelvic floor impact questionnaire
Description
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
Time Frame
up to 3 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghulam Fatima, PhD*
Phone
03034073057
Email
ghulam.fatima@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asma Ambreen, MS*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahore general hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghulam Fatima, PhD*
Phone
03034073057
Email
ghulam.fatima@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16021067
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.
Results Reference
background
PubMed Identifier
34135723
Citation
Trahan J, Leger E, Allen M, Koebele R, Yoffe MB, Simon C, Alappattu M, Figuers C. The Efficacy of Manual Therapy for Treatment of Dyspareunia in Females: A Systematic Review. J Womens Health Phys Therap. 2019 Jan-Mar;43(1):28-35. doi: 10.1097/jwh.0000000000000117.
Results Reference
background
PubMed Identifier
17472951
Citation
Fisher KA. Management of dyspareunia and associated levator ani muscle overactivity. Phys Ther. 2007 Jul;87(7):935-41. doi: 10.2522/ptj.20060168. Epub 2007 May 1.
Results Reference
background
PubMed Identifier
23812462
Citation
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.
Results Reference
background
PubMed Identifier
16020150
Citation
Rosenbaum TY. Physiotherapy treatment of sexual pain disorders. J Sex Marital Ther. 2005 Jul-Sep;31(4):329-40. doi: 10.1080/00926230590950235.
Results Reference
background
PubMed Identifier
28372937
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.
Results Reference
background
PubMed Identifier
31286158
Citation
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.
Results Reference
background
PubMed Identifier
17454519
Citation
Meyer-Bahlburg HF, Dolezal C. The female sexual function index: a methodological critique and suggestions for improvement. J Sex Marital Ther. 2007 May-Jun;33(3):217-24. doi: 10.1080/00926230701267852.
Results Reference
background
PubMed Identifier
1437591
Citation
Cline ME, Herman J, Shaw ER, Morton RD. Standardization of the visual analogue scale. Nurs Res. 1992 Nov-Dec;41(6):378-80. No abstract available.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs