Pelvic Organ ProlapseNCT03809806
Four-arm Mesh for Vaginal Stump Prolapse
A study testing 4-arm polypropylene mesh surgery, The Female Sexual Function Index (FSFI) questionnaire and King Health Questionnaire (KHQ) in people with Pelvic Organ Prolapse and Sexual Function Abnormal, run by Medical University of Lublin at 1 site in Poland.
Trial summary
To estimate the safety and efficacy of performing modified anterior transvaginal mesh surgery using polypropylene mesh for treatment of advanced urogenital prolapse after hysterectomy (stage III and IV vc Pelvic Organ Prolapse Quantification [POP-Q] system staging). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Sexual Function Abnormal
- What is being tested?
- 4-arm polypropylene mesh surgery, The Female Sexual Function Index (FSFI) questionnaire and King Health Questionnaire (KHQ)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2014to 31 Dec 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pelvic Organ Prolapse Quantification (POPQ) III and IV vc after hysterectomy
Who cannot join
- malignant diseases
- unability to understand informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Four-arm Mesh for Vaginal Stump Prolapse: Surgical Technique and Outcomes
To estimate the safety and efficacy of performing modified anterior transvaginal mesh surgery using polypropylene mesh for treatment of advanced urogenital prolapse after hysterectomy (stage III and IV vc Pelvic Organ Prolapse Quantification [POP-Q] system staging).
Read the detailed description
Pelvic reconstructive procedures were primarily performed using the transvaginal four arm polypropylene mesh, which was inserted through: upper arms- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments. All patients underwent hysterectomy in the past apart from one which underwent vaginal hysterectomy during the procedure. Perineoplasty was performed additionally, if indicated. Subjective and objective evaluations included Pelvic Organ Prolapse Quantification [POP-Q] staging, preoperative and 1-year postoperative questionnaires were performed.
- Conditions
- Pelvic Organ Prolapse, Sexual Function Abnormal
- Being tested
- 4-arm polypropylene mesh surgery, The Female Sexual Function Index (FSFI) questionnaire, King Health Questionnaire (KHQ), Pelvic Organ Prolapse Quantification (POPQ) staging, Postoperative questionnaire
- Keywords
- vaginal stump prolapse, sexual function, quality of life
- Medical subject headings
- Pelvic Organ Prolapse, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-arm polypropylene mesh surgeryProcedure or surgery
Pelvic reconstructive procedures were performed with the use of 4-arm mesh:upper arms through- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments.
The Female Sexual Function Index (FSFI) questionnaireDiagnostic test
patients fulfilled questionnaire before and 1 year after procedure
King Health Questionnaire (KHQ)Diagnostic test
patients fulfilled questionnaire before and 1 year after procedure
Pelvic Organ Prolapse Quantification (POPQ) stagingDiagnostic test
Pelvic Organ Prolapse staging before and 1 year after the procedure
Postoperative questionnaireDiagnostic test
Postoperative questionnaire assessing quality of life fulfilled by patients 1 year after procedure
The Short Form Health Survey (SF 36) questionnaireDiagnostic test
patients fulfilled questionnaire before and 1 year after procedure
| Study group | Role | What they receive |
|---|---|---|
| patients after hysterectomy | Other | modified anterior transvaginal mesh surgery Receives: Procedure: 4-arm polypropylene mesh surgery; Diagnostic Test: The Female Sexual Function Index (FSFI) questionnaire; Diagnostic Test: King Health Questionnaire (KHQ); Diagnostic Test: Pelvic Organ Prolapse Quantification (POPQ) staging; Diagnostic Test: Postoperative questionnaire; Diagnostic Test: The Short Form Health Survey (SF 36) questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure
assessment of POPQ 1 year after mesh operation, Pelvic Organ Prolapse Quantification system (POP-Q) refers to an objective, site-specific system for describing, quantifying, and staging pelvic support in women. It provides a standardized tool for documenting, comparing, and communicating clinical findings with proven interobserver and intraobserver reliability
Measured: 1 year
Secondary outcomes (3)
Sexual function 1 year after procedure
assessment of sexual function before and 1 year after the procedure with the use of The Female Sexual Function Index questionnaire
Measured: 1 year
Urinary incontinence 1 year after procedure
assessment of urinary incontinence before and 1 year after the procedure with the use of the Urogenital Distress Inventory (UDI 6) and the Incontinence Impact Questionnaire (IIQ 7) questionnaire
Measured: 1 year
quality of life 1 year after procedure
assessment of quality of life before and 1 year after the procedure with the use of The Short Form Health Survey (SF 36)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Jan 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with vaginal stump prolapse who had undergone hysterectomy in the past
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paweł Miotła, Medical University of Lublin
- Investigators
- Tomasz Rechberger, Professor, Principal investigator, 2nd Gynecology Department Medical University in Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809806
- Sponsor's protocol ID
- 02/2019
- Status last verified
- Jan 2019
- First submitted
- 16 Jan 2019
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four-arm Mesh for Vaginal Stump Prolapse: Surgical Technique and Outcomes
- ClinicalTrials.gov ID
- NCT03809806
- Acronym / sponsor ID
- 02/2019
- Conditions
- Pelvic Organ Prolapse, Sexual Function Abnormal
- Keywords
- vaginal stump prolapse, sexual function, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 18 Jan 2019 (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.
To estimate the safety and efficacy of performing modified anterior transvaginal mesh surgery using polypropylene mesh for treatment of advanced urogenital prolapse after hysterectomy (stage III and IV vc Pelvic Organ Prolapse Quantification [POP-Q] system staging).
Detailed description
Pelvic reconstructive procedures were primarily performed using the transvaginal four arm polypropylene mesh, which was inserted through: upper arms- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments. All patients underwent hysterectomy in the past apart from one which underwent vaginal hysterectomy during the procedure. Perineoplasty was performed additionally, if indicated. Subjective and objective evaluations included Pelvic Organ Prolapse Quantification [POP-Q] staging, preoperative and 1-year postoperative questionnaires were performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with vaginal stump prolapse who had undergone hysterectomy in the past
| Arm | Type | Receives |
|---|---|---|
| patients after hysterectomy | Other | Procedure: 4-arm polypropylene mesh surgery, Diagnostic Test: The Female Sexual Function Index (FSFI) questionnaire, Diagnostic Test: King Health Questionnaire (KHQ), Diagnostic Test: Pelvic Organ Prolapse Quantification (POPQ) staging, Diagnostic Test: Postoperative questionnaire, Diagnostic Test: The Short Form Health Survey (SF 36) questionnairemodified anterior transvaginal mesh surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pelvic Organ Prolapse Quantification (POPQ) III and IV vc after hysterectomy
Key exclusion criteria (2 listed)
- malignant diseases
- unability to understand informed consent
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 |
|---|---|---|
| 4-arm polypropylene mesh surgeryPelvic reconstructive procedures were performed with the use of 4-arm mesh:upper arms through- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments. | Procedure or surgery | patients after hysterectomy |
| The Female Sexual Function Index (FSFI) questionnairepatients fulfilled questionnaire before and 1 year after procedure | Diagnostic test | patients after hysterectomy |
| King Health Questionnaire (KHQ)patients fulfilled questionnaire before and 1 year after procedure | Diagnostic test | patients after hysterectomy |
| Pelvic Organ Prolapse Quantification (POPQ) stagingPelvic Organ Prolapse staging before and 1 year after the procedure | Diagnostic test | patients after hysterectomy |
| Postoperative questionnairePostoperative questionnaire assessing quality of life fulfilled by patients 1 year after procedure | Diagnostic test | patients after hysterectomy |
| The Short Form Health Survey (SF 36) questionnairepatients fulfilled questionnaire before and 1 year after procedure | Diagnostic test | patients after hysterectomy |
Primary outcome
Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure
Time frame: 1 year
assessment of POPQ 1 year after mesh operation, Pelvic Organ Prolapse Quantification system (POP-Q) refers to an objective, site-specific system for describing, quantifying, and staging pelvic support in women. It provides a standardized tool for documenting, comparing, and communicating clinical findings with proven interobserver and intraobserver reliability
3 secondary outcomes
Sexual function 1 year after procedure
Time frame: 1 year
Urinary incontinence 1 year after procedure
Time frame: 1 year
quality of life 1 year after procedure
Time frame: 1 year
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 18 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Tomasz Rechberger, Professor principal investigator
2nd Gynecology Department Medical University in Lublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-arm polypropylene mesh surgery, The Female Sexual Function Index (FSFI) questionnaire and King Health Questionnaire (KHQ) in people with Pelvic Organ Prolapse and Sexual Function Abnormal, run by Medical University of Lublin at 1 site in Poland.
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 2 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 18 Jan 2019. 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 Poland. 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?
Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure (time frame: 1 year). 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 18 Jan 2019.