Pelvic Organ ProlapsePTOSNCT02193607
Outcomes of Pelvic Surgery With and Without Anti-incontinence Procedure in Occult Stress Urinary Incontinence Patients
A study testing TVT-O and Improved reconstruction pelvic surgery in people with Pelvic Organ Prolapse and Stress Urinary Incontinence, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
1. To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O) procedure, when added to a planned improved reconstruction pelvic surgery, improves the rate of urinary stress continence in subjects with occult stress incontinence. 2. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Stress Urinary Incontinence, Other Specified Urinary Incontinence
- What is being tested?
- TVT-O and Improved reconstruction pelvic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jan 2017
- 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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In the absence of medical contraindications for improved pelvic floor reconstruction surgery and the TVT-O surgery
- Bulge of paries anterior vaginas stage III-IV
- Uterine prolapse stage II-II
- Without symptoms of stress urinary incontinence
- Screening tests of occult stress urinary incontinence(OSUI) should be positive
- ≥55 years old.
Who cannot join
- Pregnancy
- Illegible to follow up after surgery
- Previous surgery for stress urinary incontinence
- Unfinished data collection before surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Obstetrics and Gynecology Department, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Improved Reconstruction Pelvic Surgery With and Without Tension-free Vaginal Tape-obturator in Women With Occult Stress Urinary Incontinence(PTOS): a Randomized Controlled Trial
- To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O) procedure, when added to a planned improved reconstruction pelvic surgery, improves the rate of urinary stress continence in subjects with occult stress incontinence.
- Observe the immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a TVT-O procedure.
Read the detailed description
The primary aim of this randomized study is evaluate whether a standardized TVT-O procedure, when added to a planned improved reconstruction pelvic surgery for the treatment of pelvic organ prolapse, improves the rate of urinary stress continence in subjects with occult stress incontinence. Secondary aims include comparison of immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a TVT-O procedure. The value of preoperative urodynamic testing with prolapse reduction and 1 hour pad test will also be compared between subjects with and without a concomitant TVT-O procedure.
- Being tested
- TVT-O, Improved reconstruction pelvic surgery
- Keywords
- Occult stress incontinence, Pelvic Organ Prolapse, Surgical Intervention, TVT-O(Tension-free vaginal tape-obturator), Improved Reconstructive Pelvic Surgery, Combined Surgery, Two-step Approach, Prophylactic Incontinence Procedure, Randomized Controlled Trial
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVT-OProcedure or surgery
Artificial mesh belt is placed in the middle urethra to provide support to remain no leak
Improved reconstruction pelvic surgeryProcedure or surgery
Repair of severe pelvic organ prolapse with mesh.
| Study group | Role | What they receive |
|---|---|---|
| No TVT-O | Active comparator | Improved reconstruction pelvic surgery Receives: Procedure: Improved reconstruction pelvic surgery |
| Combined surgery group | Experimental | Improved reconstruction pelvic surgery TVT-O procedure Receives: Procedure: TVT-O; Procedure: Improved reconstruction pelvic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress incontinence
Urine loss from physical activity such as coughing, sneezing or laughing.
Measured: 3 months to 2 years post-operation
Secondary outcomes (2)
Immediate and short-term complications
Immediate and short-term complications such as hemorrhage, bladder perforation and infection.
Measured: Intraoperative and 2 years post-opeartion
Overall urinary tract function
Overall urinary tract function: two validated questionnaires, standardized POP-Q measurements, urodynamic testing with prolapse reduction and 1 hour pad test.
Measured: 3 months, 12 months and 2 years post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan Zhu, MD, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193607
- Sponsor's protocol ID
- PTOS-2014
- Acronym
- PTOS
- Status last verified
- Jul 2014
- First submitted
- 19 Jun 2014
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.
PubMed 22716974Schierlitz L, Dwyer PL, Rosamilia A, De Souza A, Murray C, Thomas E, Hiscock R, Achtari C. Pelvic organ prolapse surgery with and without tension-free vaginal tape in women with occult or asymptomatic urodynamic stress incontinence: a randomised controlled trial. Int Urogynecol J. 2014 Jan;25(1):33-40. doi: 10.1007/s00192-013-2150-7. Epub 2013 Jun 28.
PubMed 23812579Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208.
PubMed 16611949
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Reconstruction Pelvic Surgery With and Without Tension-free Vaginal Tape-obturator in Women With Occult Stress Urinary Incontinence(PTOS): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02193607
- Acronym / sponsor ID
- PTOS / PTOS-2014
- Keywords
- Occult stress incontinence, Pelvic Organ Prolapse, Surgical Intervention, TVT-O(Tension-free vaginal tape-obturator), Improved Reconstructive Pelvic Surgery, Combined Surgery, Two-step Approach, Prophylactic Incontinence Procedure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 17 Jul 2014 (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.
- To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O) procedure, when added to a planned improved reconstruction pelvic surgery, improves the rate of urinary stress continence in subjects with occult stress incontinence.
- Observe the immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a TVT-O procedure.
Detailed description
The primary aim of this randomized study is evaluate whether a standardized TVT-O procedure, when added to a planned improved reconstruction pelvic surgery for the treatment of pelvic organ prolapse, improves the rate of urinary stress continence in subjects with occult stress incontinence. Secondary aims include comparison of immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a TVT-O procedure. The value of preoperative urodynamic testing with prolapse reduction and 1 hour pad test will also be compared between subjects with and without a concomitant TVT-O procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No TVT-O | Active comparator | Procedure: Improved reconstruction pelvic surgeryImproved reconstruction pelvic surgery |
| Combined surgery group | Experimental | Procedure: TVT-O, Procedure: Improved reconstruction pelvic surgeryImproved reconstruction pelvic surgery TVT-O procedure |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In the absence of medical contraindications for improved pelvic floor reconstruction surgery and the TVT-O surgery
- Bulge of paries anterior vaginas stage III-IV
- Uterine prolapse stage II-II
- Without symptoms of stress urinary incontinence
- Screening tests of occult stress urinary incontinence(OSUI) should be positive
Key exclusion criteria (4 listed)
- Pregnancy
- Illegible to follow up after surgery
- Previous surgery for stress urinary incontinence
- Unfinished data collection before surgery
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 |
|---|---|---|
| TVT-OArtificial mesh belt is placed in the middle urethra to provide support to remain no leak | Procedure or surgery | Combined surgery group |
| Improved reconstruction pelvic surgeryRepair of severe pelvic organ prolapse with mesh. | Procedure or surgery | Combined surgery group, No TVT-O |
Primary outcome
Stress incontinence
Time frame: 3 months to 2 years post-operation
Urine loss from physical activity such as coughing, sneezing or laughing.
2 secondary outcomes
Immediate and short-term complications
Time frame: Intraoperative and 2 years post-opeartion
Overall urinary tract function
Time frame: 3 months, 12 months and 2 years post-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
- Background: PubMed 22716974Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.
- Background: PubMed 23812579Schierlitz L, Dwyer PL, Rosamilia A, De Souza A, Murray C, Thomas E, Hiscock R, Achtari C. Pelvic organ prolapse surgery with and without tension-free vaginal tape in women with occult or asymptomatic urodynamic stress incontinence: a randomised controlled trial. Int Urogynecol J. 2014 Jan;25(1):33-40. doi: 10.1007/s00192-013-2150-7. Epub 2013 Jun 28.
- Background: PubMed 16611949Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208.
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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.
Lan Zhu, MD study director
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TVT-O and Improved reconstruction pelvic surgery in people with Pelvic Organ Prolapse and Stress Urinary Incontinence, run by Peking Union Medical College Hospital at 1 site in China.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Jul 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 China. 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?
Results are not available in the source record.
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?
Stress incontinence (time frame: 3 months to 2 years post-operation). 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 NCT02193607, which also lists 3 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 17 Jul 2014.