Pelvic Floor DisordersNCT05950633
Postoperative Active Recovery
A study testing Active Recovery in people with Pelvic Floor Disorders, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This is a study evaluating a novel active recovery program in the immediate postoperative period following pelvic reconstructive surgery. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Active Recovery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 89
- Undergoing minimally invasive apical prolapse reconstructive procedure at OHSU. This includes laparoscopic and robotic-assisted sacrocolpopexy, laparoscopic and vaginal uterosacral ligament suspension, and vaginal sacrospinous ligament fixation. We will include patients undergoing concomitant procedures such as hysterectomy and incontinence procedures.
- Have access to reliable email for communication and questionnaires.
Who cannot join
- Unable to consent
- Unable to read and complete questionnaires in English
- Unable to sustain 30 minutes of moderate walking/activity at baseline (self-reported)
- Use a mobility assistance device such as a walker/cane at baseline
- Balance or stability problems
- Patients on chronic opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating a Novel Active Recovery Program in the Immediate Postoperative Period Following Pelvic Reconstructive Surgery: A Randomized Control Trial
This is a study evaluating a novel active recovery program in the immediate postoperative period following pelvic reconstructive surgery.
Read the detailed description
This is a randomized controlled trial comparing usual care postoperative restrictions and a novel new active recovery program to look at differences in pelvic floor function, patient quality of life, and mental health in between groups.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Standard of Care, Active Recovery
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Participants will receive standard of care postoperative instructions
Active RecoveryOther
Participants will receive instructions to increase their fitness to walking at least 30 minutes a day for 5 days a week following surgery and abdominal and pelvic floor exercises will focus on abdominal wall strengthening and abdominal pressure management, urinary urgency and retention, bowel and constipation management
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Participants will receive standard postoperative instructions only Receives: Other: Standard of Care |
| Active Recovery | Active comparator | Participants will receive active recovery instructions with specific walking goals, abdominal strengthening exercises, and pelvic floor exercises Receives: Other: Active Recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Pelvic Floor Distress Inventory-20 (PFDI-20)
The change in the Pelvic Floor Distress Inventory-20 (PFDI-20) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate how much symptoms bother them from 0 (not at all) to 4 (quite a bit)
Measured: Baseline to 12 weeks post-surgery
Change in the Short Form Health Survey (SF-36)
The change in the Short Form Health Survey (SF-36) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate their overall health. Scores can range from 0 to 100
Measured: Baseline to 12 weeks
Change in the Patient Health Questionnaire (PHQ-9)
The change in the Patient Health Questionnaire (PHQ-9) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate how frequently problems have bothered them from 0 (not at all) to 4 (nearly every day)
Measured: Baseline to 12 weeks post-surgery
Change in the Patient Global Impression of Improvement (PGI-I)
The change in the Patient Global Impressions of Improvement (PGI-I) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate their symptoms from 1 (very much better) to 7 (very much worse)
Measured: Baseline to 12 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Sep 2023
- Primary completion31 May 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Cichowski, Oregon Health and Science University
- Investigators
- Sara Cichowski, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950633
- Sponsor's protocol ID
- OHSU IRB 25625
- Status last verified
- Mar 2025
- First submitted
- 11 Jul 2023
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Novel Active Recovery Program in the Immediate Postoperative Period Following Pelvic Reconstructive Surgery: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05950633
- Acronym / sponsor ID
- OHSU IRB 25625
- Conditions
- Pelvic Floor Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study evaluating a novel active recovery program in the immediate postoperative period following pelvic reconstructive surgery.
Detailed description
This is a randomized controlled trial comparing usual care postoperative restrictions and a novel new active recovery program to look at differences in pelvic floor function, patient quality of life, and mental health in between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareParticipants will receive standard postoperative instructions only |
| Active Recovery | Active comparator | Other: Active RecoveryParticipants will receive active recovery instructions with specific walking goals, abdominal strengthening exercises, and pelvic floor exercises |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 89
- Undergoing minimally invasive apical prolapse reconstructive procedure at OHSU. This includes laparoscopic and robotic-assisted sacrocolpopexy, laparoscopic and vaginal uterosacral ligament suspension, and vaginal sacrospinous ligament fixation. We will include patients undergoing concomitant procedures such as hysterectomy and incontinence procedures.
- Have access to reliable email for communication and questionnaires.
Key exclusion criteria (6 listed)
- Unable to consent
- Unable to read and complete questionnaires in English
- Unable to sustain 30 minutes of moderate walking/activity at baseline (self-reported)
- Use a mobility assistance device such as a walker/cane at baseline
- Balance or stability problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareParticipants will receive standard of care postoperative instructions | Other | Standard of Care |
| Active RecoveryParticipants will receive instructions to increase their fitness to walking at least 30 minutes a day for 5 days a week following surgery and abdominal and pelvic floor exercises will focus on abdominal wall strengthening and abdominal pressure management, urinary urgency and retention, bowel and constipation management | Other | Active Recovery |
Primary outcome
Change in the Pelvic Floor Distress Inventory-20 (PFDI-20)
Time frame: Baseline to 12 weeks post-surgery
The change in the Pelvic Floor Distress Inventory-20 (PFDI-20) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate how much symptoms bother them from 0 (not at all) to 4 (quite a bit)
Change in the Short Form Health Survey (SF-36)
Time frame: Baseline to 12 weeks
The change in the Short Form Health Survey (SF-36) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate their overall health. Scores can range from 0 to 100
Change in the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to 12 weeks post-surgery
The change in the Patient Health Questionnaire (PHQ-9) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate how frequently problems have bothered them from 0 (not at all) to 4 (nearly every day)
Change in the Patient Global Impression of Improvement (PGI-I)
Time frame: Baseline to 12 weeks post-surgery
The change in the Patient Global Impressions of Improvement (PGI-I) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate their symptoms from 1 (very much better) to 7 (very much worse)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Cichowski, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Recovery in people with Pelvic Floor Disorders, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Pelvic Floor Distress Inventory-20 (PFDI-20) (time frame: Baseline to 12 weeks post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.