Quality of LifePT and QOLNCT01403701
Physical Therapy on Quality of Life and Function Following Vaginal Surgery Reconstructive Surgery
A study testing Physical therapy in people with Quality of Life and Pelvic Floor Distress and Impact Scores, run by TriHealth Inc. at 1 site in United States.
Trial summary
i) The primary objective of this study is to determine if physical therapy improves postoperative quality of life in participants following vaginal reconstructive surgery for pelvic organ prolapse and urinary incontinence. ii) Secondary objectives include: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Pelvic Floor Distress and Impact Scores, Sexual Function Scores
- What is being tested?
- Physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2013
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Vaginal reconstructive surgery for prolapse
- Age of at least 18 years
- Willing to comply with physical therapy
Who cannot join
- i. Use of mesh/graft material during the prolapse repair
- ii. Abdominal or laparoscopic prolapse repair
- iii.Current genitourinary fistula or urethral diverticulum
- iv. Contraindication to surgery
- v. Unable to comply with physical therapy or office visits
- vi. Preexisting neurological condition
- vii.Concurrent surgery for fecal incontinence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Physical Therapy on Quality of Life and Function Following Vaginal Reconstructive Surgery; a Randomized Trial
- The primary objective of this study is to determine if physical therapy improves postoperative quality of life in participants following vaginal reconstructive surgery for pelvic organ prolapse and urinary incontinence. ii) Secondary objectives include:
- Comparing pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse symptoms) in participants undergoing physical therapy compared to standard postoperative care
- Comparing sexual function in participants undergoing physical therapy compared to standard postoperative care;
- Comparing postoperative pain scales, and activity assessment in participants undergoing physical therapy compared to standard postoperative care;
- Comparing pelvic floor strength and pelvic organ prolapse quantification (POPQ)(12) in participants undergoing physical therapy compared to standard postoperative care.
Read the detailed description
This is a single center randomized controlled trial assessing quality of life in participants following vaginal surgery receiving physical therapy compared to standard postoperative care. Patients will be under care of the physicians of the Division of Urogynecology and Reconstructive Pelvic Surgery. All physicians are board certified, fellowship trained urogynecologists.
- Being tested
- Physical therapy
- Keywords
- physical therapy, pelvic prolapse, incontinence, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapyBehavioural
pelvic floor physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy | Experimental | Standardized pelvic floor physical therapy Receives: Behavioral: Physical therapy |
| routine care | No intervention | Standard postoperative visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative quality of life as based on the scores of the WHO-QOL Bref in participants following vaginal reconstructive surgery for pelvic organ prolapse and urinary incontinence
Quality of life scores on the world health organization validated quality of life scale
Measured: 3-6 months
Secondary outcomes (2)
Comparing pelvic floor quality of life scores and distress related to pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse symptoms) in participants undergoing physical therapy compared to standard postoperative care
several validated indices for measuring symptoms of urinary and bowel symptoms
Measured: 3-6 months
Comparing sexual function scores in participants undergoing physical therapy compared to standard postoperative care;
based on validated indices of sexual function
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startJul 2009
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel N Pauls, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403701
- Sponsor's protocol ID
- 09015-09-020
- Acronym
- PT and QOL
- Status last verified
- Feb 2014
- First submitted
- 21 Jul 2011
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Therapy on Quality of Life and Function Following Vaginal Reconstructive Surgery; a Randomized Trial
- ClinicalTrials.gov ID
- NCT01403701
- Acronym / sponsor ID
- PT and QOL / 09015-09-020
- Keywords
- physical therapy, pelvic prolapse, incontinence, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Jul 2011 (estimated)
- 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.
- The primary objective of this study is to determine if physical therapy improves postoperative quality of life in participants following vaginal reconstructive surgery for pelvic organ prolapse and urinary incontinence. ii) Secondary objectives include:
- Comparing pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse symptoms) in participants undergoing physical therapy compared to standard postoperative care
- Comparing sexual function in participants undergoing physical therapy compared to standard postoperative care;
- Comparing postoperative pain scales, and activity assessment in participants undergoing physical therapy compared to standard postoperative care;
- Comparing pelvic floor strength and pelvic organ prolapse quantification (POPQ)(12) in participants undergoing physical therapy compared to standard postoperative care.
Detailed description
This is a single center randomized controlled trial assessing quality of life in participants following vaginal surgery receiving physical therapy compared to standard postoperative care. Patients will be under care of the physicians of the Division of Urogynecology and Reconstructive Pelvic Surgery. All physicians are board certified, fellowship trained urogynecologists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical therapy | Experimental | Behavioral: Physical therapyStandardized pelvic floor physical therapy |
| routine care | No intervention | –Standard postoperative visits |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Vaginal reconstructive surgery for prolapse
- Age of at least 18 years
- Willing to comply with physical therapy
Key exclusion criteria (7 listed)
- i. Use of mesh/graft material during the prolapse repair
- ii. Abdominal or laparoscopic prolapse repair
- iii.Current genitourinary fistula or urethral diverticulum
- iv. Contraindication to surgery
- v. Unable to comply with physical therapy or office visits
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 |
|---|---|---|
| Physical therapypelvic floor physical therapy | Behavioural | Physical therapy |
Primary outcome
postoperative quality of life as based on the scores of the WHO-QOL Bref in participants following vaginal reconstructive surgery for pelvic organ prolapse and urinary incontinence
Time frame: 3-6 months
Quality of life scores on the world health organization validated quality of life scale
2 secondary outcomes
Comparing pelvic floor quality of life scores and distress related to pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse symptoms) in participants undergoing physical therapy compared to standard postoperative care
Time frame: 3-6 months
Comparing sexual function scores in participants undergoing physical therapy compared to standard postoperative care;
Time frame: 3-6 months
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 19 Feb 2014.
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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.
Rachel N Pauls, MD principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy in people with Quality of Life and Pelvic Floor Distress and Impact Scores, run by TriHealth Inc. 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 7 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 19 Feb 2014. 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?
postoperative quality of life as based on the scores of the WHO-QOL Bref in participants following vaginal reconstructive surgery for pelvic organ prolapse and urinary incontinence (time frame: 3-6 months). 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 19 Feb 2014.