Vaginal HysterectomyNCT00222326
The Effect of Physiotherapy Treatment Following Gynaecological Surgery
A study testing Pelvic floor muscle training and lifestyle modification in people with Vaginal Hysterectomy and Pelvic Organ Prolapse Vaginal Surgery, run by University of Melbourne at 1 site in Australia.
Trial summary
Optimal pelvic floor muscle function is known to assist bladder and bowel function and control, pelvic organ support, as well as other areas of health. It is also known that problems in some of tehse areas can be a consequence of pelvic surgery. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Hysterectomy, Pelvic Organ Prolapse Vaginal Surgery
- What is being tested?
- Pelvic floor muscle training and lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2002to Apr 2007
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair
Who cannot join
- surgery for malignancy
- anti-incontinence surgery
- laparotomy
Trial locations and contacts
1 site in 1 country.
Australia1 site
School of Physiotherapy, The University of Melbourne
Melbourne, Victoria, 3010
About this study
Official title: The Effect of a Physiotherapy Treatment Program on Pelvic Function Following Gynaecological Surgery
Optimal pelvic floor muscle function is known to assist bladder and bowel function and control, pelvic organ support, as well as other areas of health. It is also known that problems in some of tehse areas can be a consequence of pelvic surgery. By addressing the requirements for good bladder and bowel function/control, and organ support in the early post-surgery phase when tissue repair and scar formation are critical, it is proposed that there will be a rduction in the longterm prevalence of bladder problems, bowel difficulties and weakened pelvic floor and abdominal muscles in post-surgery patients. This study is a randomised controlled trial to compare patients undergoing a physiotherapy-supervised pelvic floor muscle training and behavioural therapy program with a control group. It is hypothesised that at the 12 month post-operative follow-up assessment, the treatment group will demonstrate better outcomes in bladder and bowel function and control, as well as stronger pelvic floor muscle contractile strength than the control group.
Read the detailed description
Optimal pelvic floor muscle function is known to assist bladder and bowel function and control, pelvic organ support, as well as other areas of pelvic health. It is also known that problems in some of these areas can develop after pelvic surgery. By addressing the requirements for good bladder and bowel function/control, and organ support in the early post-surgical phase when tissue repair and scar formation are critical, it is proposed that there will be a reduction in the long-term prevalence of bladder and bowel dysfunction, and weak pelvic floor and abdominal muscles in post-surgical patients. There have been no previous studies investigating whether a physiotherapy intervention can assist pelvic function in this group of surgical patients.
This study aims to investigate the effect of a physiotherapy treatment program on pelvic function following gynaecological surgery.
Comparisons: Pre- and post-operative physiotherapy treatment vs no treatment following gynaecological surgery.
Outcome measures: Pelvic floor muscle strength, urine leakage, quality of life, sexual functioning, general fitness, measured at 3, 6 and 12 months post-operatively
- Being tested
- Pelvic floor muscle training and lifestyle modification
- Keywords
- Hysterectomy, Prolapse, Pelvic floor muscles, Bladder, Bowel
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle training and lifestyle modificationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor muscle training | Experimental | Pelvic floor muscle training: clinic and rooms exercise training Receives: Behavioral: Pelvic floor muscle training and lifestyle modification |
| Usual care | No intervention | Usual care as provided by the surgeon and hospital staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder symptom (prevalence and bother) questionnaire.
A questionnaire about bladder symptoms
Measured: Pre-operative compared to 12 months post-operative
Prolapse symptom (prevalence and bother) questionnaire.
A questionnaire about prolapse symptoms
Measured: Pre-operative compared to 12 months post-operative
Secondary outcomes (1)
Pelvic floor muscle strength.
Strength assessed via digital muscle testing
Measured: Pre-operative compared to 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2002
- Primary completionApr 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vaginal HysterectomyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Galea, University of Melbourne
- Investigators
- Mary P Galea, PhD, Principal investigator, The University of Melbourne, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222326
- Sponsor's protocol ID
- 08-15-10-01
- Status last verified
- Apr 2021
- First submitted
- 13 Sep 2005
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Frawley HC, Galea MP, Phillips BA. Survey of clinical practice: pre- and postoperative physiotherapy for pelvic surgery. Acta Obstet Gynecol Scand. 2005 May;84(5):412-8. doi: 10.1111/j.0001-6349.2005.00776.x.
PubMed 15842203Frawley HC, Phillips BA, Bo K, Galea MP. Physiotherapy as an adjunct to prolapse surgery: an assessor-blinded randomized controlled trial. Neurourol Urodyn. 2010 Jun;29(5):719-25. doi: 10.1002/nau.20828.
PubMed 19816918
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Physiotherapy Treatment Program on Pelvic Function Following Gynaecological Surgery
- ClinicalTrials.gov ID
- NCT00222326
- Acronym / sponsor ID
- 08-15-10-01
- Keywords
- Hysterectomy, Prolapse, Pelvic floor muscles, Bladder, Bowel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- Jul 2002
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 22 Sep 2005 (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.
Optimal pelvic floor muscle function is known to assist bladder and bowel function and control, pelvic organ support, as well as other areas of health. It is also known that problems in some of tehse areas can be a consequence of pelvic surgery. By addressing the requirements for good bladder and bowel function/control, and organ support in the early post-surgery phase when tissue repair and scar formation are critical, it is proposed that there will be a rduction in the longterm prevalence of bladder problems, bowel difficulties and weakened pelvic floor and abdominal muscles in post-surgery patients. This study is a randomised controlled trial to compare patients undergoing a physiotherapy-supervised pelvic floor muscle training and behavioural therapy program with a control group. It is hypothesised that at the 12 month post-operative follow-up assessment, the treatment group will demonstrate better outcomes in bladder and bowel function and control, as well as stronger pelvic floor muscle contractile strength than the control group.
Detailed description
Optimal pelvic floor muscle function is known to assist bladder and bowel function and control, pelvic organ support, as well as other areas of pelvic health. It is also known that problems in some of these areas can develop after pelvic surgery. By addressing the requirements for good bladder and bowel function/control, and organ support in the early post-surgical phase when tissue repair and scar formation are critical, it is proposed that there will be a reduction in the long-term prevalence of bladder and bowel dysfunction, and weak pelvic floor and abdominal muscles in post-surgical patients. There have been no previous studies investigating whether a physiotherapy intervention can assist pelvic function in this group of surgical patients.
This study aims to investigate the effect of a physiotherapy treatment program on pelvic function following gynaecological surgery.
Comparisons: Pre- and post-operative physiotherapy treatment vs no treatment following gynaecological surgery.
Outcome measures: Pelvic floor muscle strength, urine leakage, quality of life, sexual functioning, general fitness, measured at 3, 6 and 12 months post-operatively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle training | Experimental | Behavioral: Pelvic floor muscle training and lifestyle modificationPelvic floor muscle training: clinic and rooms exercise training |
| Usual care | No intervention | –Usual care as provided by the surgeon and hospital staff |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair
Key exclusion criteria (3 listed)
- surgery for malignancy
- anti-incontinence surgery
- laparotomy
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 |
|---|---|---|
| Pelvic floor muscle training and lifestyle modification | Behavioural | Pelvic floor muscle training |
Primary outcome
Bladder symptom (prevalence and bother) questionnaire.
Time frame: Pre-operative compared to 12 months post-operative
A questionnaire about bladder symptoms
Prolapse symptom (prevalence and bother) questionnaire.
Time frame: Pre-operative compared to 12 months post-operative
A questionnaire about prolapse symptoms
1 secondary outcome
Pelvic floor muscle strength.
Time frame: Pre-operative compared to 12 months post-operative
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 3 May 2021.
- Background: PubMed 15842203Frawley HC, Galea MP, Phillips BA. Survey of clinical practice: pre- and postoperative physiotherapy for pelvic surgery. Acta Obstet Gynecol Scand. 2005 May;84(5):412-8. doi: 10.1111/j.0001-6349.2005.00776.x.
- Results publication: PubMed 19816918Frawley HC, Phillips BA, Bo K, Galea MP. Physiotherapy as an adjunct to prolapse surgery: an assessor-blinded randomized controlled trial. Neurourol Urodyn. 2010 Jun;29(5):719-25. doi: 10.1002/nau.20828.
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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.
Mary P Galea, PhD principal investigator
The University of Melbourne, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training and lifestyle modification in people with Vaginal Hysterectomy and Pelvic Organ Prolapse Vaginal Surgery, run by University of Melbourne at 1 site in Australia.
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 1 inclusion and 3 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 3 May 2021. 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 Australia. 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?
Bladder symptom (prevalence and bother) questionnaire. (time frame: Pre-operative compared to 12 months post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00222326, which also lists 2 linked publications.
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 3 May 2021.