Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized controlled pilot study comparing a home pelvic floor physical therapy program to routine post-operative care for patients undergoing endometriosis excisional surgery without hysterectomy. Quality of life and endometriosis symptoms will be compared following the recovery period.
This is a randomized controlled pilot study conducted at a single institution comparing a home pelvic floor physical therapy program to routine post-operative care for patients undergoing endometriosis excisional surgery without hysterectomy. Patients will be recruited from a referral gynecological surgery group specializing in the diagnosis and treatment of pelvic pain and endometriosis. The goal is to assess the role of the active recovery program on quality of life and on pain and endometriosis symptoms.
Subjects will be randomized to routine post-operative care or to a home physical therapy program, in which they will receive written instruct ions and videos of exercises to complete immediately after surgery. The home exercise program was developed by the Department of Urogynecology in conjunction with pelvic floor physical therapists, and includes videos created by the education communications division. Quality of life, pain score, and endometriosis symptoms will be assessed at their pre-operative appointment, and at 6 and 12 weeks postoperatively.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Postoperative Instructions | Active Comparator | Participants will receive standard postoperative recovery instructions |
|
| Active Recovery | Experimental | Participants will receive postoperative instructions to follow an active recovery protocol focused on increasing activity level, core strength exercises, and pelvic floor exercises focused on urinary and bowel symptoms. Exercises are to be completed twice per day for the 12 weeks following surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Recovery | Behavioral | Participants will receive postoperative instructions to follow an active recovery protocol focused on increasing activity level, core strength exercises, and pelvic floor exercises focused on urinary and bowel symptoms. Exercises are to be completed twice per day for the 12 weeks following surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form Survey (SF-36) | The Short Form Survey (SF-36) is a 36-item survey regarding general health and pain and its impact on quality of life including physical activities, work, social activities, and emotional well-being over the last four weeks. Scores range from 0 to 100 with a higher score representing a more favorable health state. | Collected immediately following surgery, 6 weeks following surgery, and 12 weeks following surgery |
| Pelvic Floor Impact Questionnaire (PFIQ) | The Pelvic Floor Impact Questionnaire (PFIQ) asks about how bladder, bowel, and pelvic symptoms affect the ability to do physical activities as well as their impact on emotional well-being over the last 3 months. Scores range from 0 to 300 with a lower score representing a lesser impact on quality of life. | Collected immediately following surgery and 12 weeks following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Pain measured using a Visual Analog Scale (VAS). This scale asks patients to rate their pelvic pain and dyspareunia over the last 4 weeks. Responses are on a scale from 0 to 10, with 10 being the worst pain. | Collected at baseline, 6 weeks following surgery, and 12 weeks following surgery. |
| Endometriosis Health Profile (EHP-5) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Women's Health Research Unit Department of Ob/Gyn | Contact | 503-494-3666 | whru@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Wong | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Participants will be randomized in a 1:1 ratio to either standard postoperative instructions or the active recovery intervention group.
Not provided
Not provided
Not provided
Not provided
|
| Standard Postoperative Instructions | Behavioral | Standard of care postoperative instructions covering incision care, pain control, dietary instructions, and emergency precautions. Also includes guidelines regarding pelvic rest and lifting restrictions. |
|
The Endometriosis Health Profile (EHP-5) is a 5-item questionnaire asking about the perception of endometriosis symptoms on physical ability, emotional well-being, mood, social isolation, and appearance over the last four weeks. Scores range from 0 to 100 where 0 indicates the best health status. |
| Collected at baseline, 6 weeks following surgery, and 12 weeks following surgery. |
| D000091662 | Genital Diseases |