Pelvic Organ ProlapseNCT01541748
Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
An observational study of Pelvic Organ Prolapse, run by Coloplast A/S at 5 sites in United States.
Trial summary
This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Axis
- How many people
- 74 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2011to 11 Nov 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be adult female patients with pelvic organ prolapse, POP-Q Stage ≥ 2 that are clinically indicated for surgical intervention with Axis human tissue in the anterior, posterior, or combined (anterior and posterior) compartments at the institutions designated for this study.
Who may be able to join
- Adult female at least 18 years of age.
- Willing and able to provide written informed consent.
- Confirmed pelvic organ prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading requiring surgical intervention in the anterior, posterior or combined (anterior and posterior) compartment.
- Willing and able to complete all follow-up visits and procedures indicated in this protocol.
Who cannot join
- Concurrent surgical treatment of pelvic organ prolapse using anything other than the Axis Dermis.[Note: concurrent mid-urethral sling placement for treatment of stress urinary incontinence is allowed].
- Confirmed Stage 2 or higher prolapse as determined by POP-Q prolapse grading for a compartment that is not being repaired in the same procedure. (Concurrent POP-Q Stage 1 repair is at the physician's discretion.)
- Previous pelvic organ prolapse repair using biologic, or synthetic grafts. [Note: previous mid-urethral sling for treatment of stress urinary incontinence is allowed]
- Pregnant or a desire to become pregnant in the future.
- Previous radiation or other treatments for cancer in the pelvic area.
- Severe urogenital atrophy.
- Immunosuppression and/or current systemic steroid user.
- Any contraindication to the surgical procedure.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103
Boston Urogynecology Associates
Cambridge, Massachusetts, 02138
Female Pelvic Medicine and Urogynecology Institute of MI/Grand Rapids Women's Health
Grand Rapids, Michigan, 49503
Philadelphia Urosurgical Associates
Philadelphia, Pennsylvania, 19107
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
Read the detailed description
The study population will be adult female patients with pelvic organ prolapse, POP-Q Stage ≥ 2 that are clinically indicated for surgical intervention with Axis Allograft Dermis in the anterior, posterior or combined (anterior and posterior) compartments.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Axis
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AxisOther
Coloplast's Axis™ Allograft Dermis is used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
| Study group | Role | What they receive |
|---|---|---|
| AXIS Allograft Dermis | Participants receiving AXIS Allograft Dermis for anterior, posterior or combined (anterior and posterior) female pelvic floor repair. Receives: Other: Axis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline and One Year.
The Pelvic Organ Prolapse Quantification system (POP-Q) is used to measure pelvic organ prolapse. POP-Q Stages are:
Stage 0: No prolapse is demonstrated Stage 1: The criteria for stage 0 are not met, but the most distal portion of the prolapse is greater than 1 cm above the level of the hymen Stage 2: The most distal portion of the prolapse is greater than or equal to 1 centimeter proximal to or distal to the plane of the hymen Stage 3: The most distal portion of the prolapse is greater than 1 centimeter below the plan of the hymen but protrudes no further than 2 centimeters less that the total vaginal length in centimeters Stage 4: The distal portion of the prolapse protrudes to at least (TVL-2) centimeters.
Improvement at one year is categorized as follows:
Cured: Pop-Q Stage reduced to 0 or 1, or improved by 2 stages from baseline Improved: POP-Q Stage > 1, but improved by 1 stage from baseline Failed: POP-Q Stage stayed the same or increased in severity from baseline
Measured: 1 year
Secondary outcomes (17)
Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline and Six Weeks
The Pelvic Organ Prolapse Quantification system (POP-Q) is used to measure pelvic organ prolapse. POP-Q Stages are:
Stage 0: No prolapse is demonstrated Stage 1: The criteria for stage 0 are not met, but the most distal portion of the prolapse is greater than 1 cm above the level of the hymen Stage 2: The most distal portion of the prolapse is greater than or equal to 1 centimeter proximal to or distal to the plane of the hymen Stage 3: The most distal portion of the prolapse is greater than 1 centimeter below the plan of the hymen but protrudes no further than 2 centimeters less that the total vaginal length in centimeters Stage 4: The distal portion of the prolapse protrudes to at least (TVL-2) centimeters.
Improvement at one year is categorized as follows:
Cured: Pop-Q Stage reduced to 0 or 1, or improved by 2 stages from baseline Improved: POP-Q Stage > 1, but improved by 1 stage from baseline Failed: POP-Q Stage stayed the same or increased in severity from baseline
Measured: 6 weeks
Percentage of Participants With POP-Q Stage Improvement After POP Repair With Axis Assessed by POP-Q Stage Improvement Based Upon Prolapse Grading of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Between Baseline and Six Months
The Pelvic Organ Prolapse Quantification system (POP-Q) is used to measure pelvic organ prolapse. POP-Q Stages are:
Stage 0: No prolapse is demonstrated Stage 1: The criteria for stage 0 are not met, but the most distal portion of the prolapse is greater than 1 cm above the level of the hymen Stage 2: The most distal portion of the prolapse is greater than or equal to 1 centimeter proximal to or distal to the plane of the hymen Stage 3: The most distal portion of the prolapse is greater than 1 centimeter below the plan of the hymen but protrudes no further than 2 centimeters less that the total vaginal length in centimeters Stage 4: The distal portion of the prolapse protrudes to at least (TVL-2) centimeters.
Improvement at one year is categorized as follows:
Cured: Pop-Q Stage reduced to 0 or 1, or improved by 2 stages from baseline Improved: POP-Q Stage > 1, but improved by 1 stage from baseline Failed: POP-Q Stage stayed the same or increased in severity from baseline
Measured: 6 months
Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline at 24 Months
The Pelvic Organ Prolapse Quantification system (POP-Q) is used to measure pelvic organ prolapse. POP-Q Stages are:
Stage 0: No prolapse is demonstrated Stage 1: The criteria for stage 0 are not met, but the most distal portion of the prolapse is greater than 1 cm above the level of the hymen Stage 2: The most distal portion of the prolapse is greater than or equal to 1 centimeter proximal to or distal to the plane of the hymen Stage 3: The most distal portion of the prolapse is greater than 1 centimeter below the plan of the hymen but protrudes no further than 2 centimeters less that the total vaginal length in centimeters Stage 4: The distal portion of the prolapse protrudes to at least (TVL-2) centimeters.
Improvement at one year is categorized as follows:
Cured: Pop-Q Stage reduced to 0 or 1, or improved by 2 stages from baseline Improved: POP-Q Stage > 1, but improved by 1 stage from baseline Failed: POP-Q Stage stayed the same or increased in severity from baseline
Measured: 24 months
Percentage of Participants With POP-Q Stage Improvement After POP Repair With Axis Assessed by POP-Q Stage Improvement Based Upon Prolapse Grading of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Between Baseline at 36 Months
The Pelvic Organ Prolapse Quantification system (POP-Q) is used to measure pelvic organ prolapse. POP-Q Stages are:
Stage 0: No prolapse is demonstrated Stage 1: The criteria for stage 0 are not met, but the most distal portion of the prolapse is greater than 1 cm above the level of the hymen Stage 2: The most distal portion of the prolapse is greater than or equal to 1 centimeter proximal to or distal to the plane of the hymen Stage 3: The most distal portion of the prolapse is greater than 1 centimeter below the plan of the hymen but protrudes no further than 2 centimeters less that the total vaginal length in centimeters Stage 4: The distal portion of the prolapse protrudes to at least (TVL-2) centimeters.
Improvement at one year is categorized as follows:
Cured: Pop-Q Stage reduced to 0 or 1, or improved by 2 stages from baseline Improved: POP-Q Stage > 1, but improved by 1 stage from baseline Failed: POP-Q Stage stayed the same or increased in severity from baseline
Measured: 36 months
Change in Participant Sexual Satisfaction From Baseline After Pelvic Organ Prolapse Repair With Axis Allograft Dermis Measured by Participant Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) at 6 Months
The PISQ-12 is the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Sexual Function in women after pelvic organ prolapse repair with Axis Allograft Dermis measured by PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totaling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
Measured: Baseline and 6 months
Change in Patient Sexual Satisfaction From Baseline After Pelvic Organ Prolapse Repair With Axis Allograft Dermis Measured by Participant Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) at 12 Months
The PISQ-12 is the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Sexual Function in women after pelvic organ prolapse repair with Axis Allograft Dermis measured by PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totaling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
Measured: Baseline and 12 months
Change in Patient Sexual Satisfaction From Baseline After Pelvic Organ Prolapse Repair With Axis Allograft Dermis Measured by Participant Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) at 24 Months
The PISQ-12 is the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Sexual Function in women after pelvic organ prolapse repair with Axis Allograft Dermis measured by PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totaling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
Measured: Baseline and 24 months
Change in Patient Sexual Satisfaction From Baseline After Pelvic Organ Prolapse Repair With Axis Allograft Dermis Measured by Participant Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) at 36 Months
The PISQ-12 is the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Sexual Function in women after pelvic organ prolapse repair with Axis Allograft Dermis measured by PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totaling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
Measured: Baseline and 36 months
Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 12 Months
The PGI-I Index consists of one question and was collected at 12 months. The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation." There are seven possible responses including, "very much better," "much better," "a little better," "no change," "a little worse," "much worse," and "very much worse and the subject chooses one response.
Measured: 12 months
Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 24 Months
The PGI-I Index consists of one question and was collected at 24 months. The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation." There are seven possible responses including, "very much better," "much better," "a little better," "no change," "a little worse," "much worse," and "very much worse and the subject chooses one response.
Measured: 24 month
Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 36 Months
The PGI-I Index consists of one question and was collected at 36 months. The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation." There are seven possible responses including, "very much better," "much better," "a little better," "no change," "a little worse," "much worse," and "very much worse and the subject chooses one response.
Measured: 36 months
Change in Pelvic/Bladder Pain With Daily Activity Visual Analog Scale (VAS) Questionnaire From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, 36 Months
The Visual analog scales (VAS) Questionnaire is a questionnaire that asks the participant to mark a place on a scale that aligns with their level of pain. Participants were asked to make a vertical mark on a 10 centimeter line marked with "No Pain" and "Worst Pain" at each end and the line was measured to the tenths decimal place. A lower score indicates less pain.
Measured: Baseline and 6 weeks, 6 months, 12 months, 24 months, 36 months
Change in Pelvic/Bladder Pain With Sexual Activity Visual Analog Scale (VAS) Questionnaire From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, 36 Months
The Visual analog scales (VAS) Questionnaire is a questionnaire that asks the participant to mark a place on a scale that aligns with their level of pain. Participants were asked to make a vertical mark on a 10 centimeter line with the left end marker labeled "No Pain" and the right end marker labeled "Worst Pain." The line was measured to the tenths decimal place. Zero was the minimum value and 10 was the maximum value. Higher scores indicated a greater amount of pain.
Measured: Baseline and 6 weeks, 6 months, 1 year, 2 years, 3 years
Percentage of Participants Who Had Surgical Revision of the Index Prolapse Compartment(s) After Pelvic Organ Prolapse Repair With Axis
Percentage of participants who had surgical revision of the index prolapse compartment(s) after pelvic organ prolapse repair with Axis from the time of the index procedure to the end of study visit.
Measured: 3 year
Ratings for the Validated Surgical Satisfaction Questionnaire (SSQ-8) in Women Following Surgery to Correct Pelvic Organ Prolapse Repair With Axis Allograft Dermis at the 6 Week, 6 Month, 12 Month, 24 Month, and 36 Month Visits.
The Surgical Satisfaction Questionnaire (SSQ-8) is a validated questionnaire consisting of eight questions assessing participant satisfaction with the results of their surgery to correct urinary incontinence and/or pelvic organ prolapse. Scoring is implemented with the mean average of the 8 scores multiplied by 25, yielding a potential range of scores from 0 to 100. The higher the score is, the greater the degree of surgical satisfaction.
Measured: 6 week, 6 month, 12 month, 24 month, and 36 month visits
Change in Pelvic Floor Distress Inventory (PFDI-20) Questionnaire After Pelvic Organ Prolapse Repair With Axis Allograft Dermis From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, and 36 Months
The Pelvic Floor Distress Inventory Questionnaire (PFDI-20) is a questionnaire with 20 questions that measures symptom distress and impact of health-related quality of life. The PFDI-20 has three scales:
Pelvic Organ Prolapse Distress Inventory (POPDI-6), Colorectal-Anal Distress Inventory (CRADI-8), and Urinary Distress Inventory (UDI-6). Each of the 3 scales of the PFDI-20 is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 to 300. Higher scores indicate more distress.
Measured: Baseline and 6 weeks, 6 months, 12 Months, 24 Months, 36 Months
Change in the Participants Response on the Pelvic Floor Impact Questionnaire (PFIQ) From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, 36 Months
The Pelvic Floor Impact Questionnaire (PFIQ) measures impact of bladder, bowel, and vaginal symptoms on daily physical activity, travel, social/relationships, and emotional health. The PFIQ-7 has three scales: the Urinary Impact Questionnaire (UIQ-7), the Colorectal-Anal Impact Questionnaire (CRAIQ-7), and the Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7). Response options range from 0 ("not at all") to 3 ("quite a bit"). Per scale, the mean score of answered items is multiplied by 33.3 to obtain the scale score (range 0-100) [4]. Summary scores are calculated by adding up the scale scores (range 0-300) [4]. Higher scores indicate more impact on daily activity.
Measured: Baseline and 6 weeks, 6 months, 12 Months, 24 Months, 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startNov 2011
- Primary completion11 Nov 2018
- Study completion11 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristine Whitmore, MD, Principal investigator, Virtua Female Pelvic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541748
- Sponsor's protocol ID
- CP009SU
- Status last verified
- Jun 2020
- First submitted
- 17 Feb 2012
- Last updated
- 30 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
- ClinicalTrials.gov ID
- NCT01541748
- Acronym / sponsor ID
- CP009SU
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- 11 Nov 2018 (actual)
- Study completion
- 11 Nov 2018 (actual)
- First posted
- 1 Mar 2012 (estimated)
- Results
- Posted 18 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
Detailed description
The study population will be adult female patients with pelvic organ prolapse, POP-Q Stage ≥ 2 that are clinically indicated for surgical intervention with Axis Allograft Dermis in the anterior, posterior or combined (anterior and posterior) compartments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AXIS Allograft Dermis | – | Other: AxisParticipants receiving AXIS Allograft Dermis for anterior, posterior or combined (anterior and posterior) female pelvic floor repair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be adult female patients with pelvic organ prolapse, POP-Q Stage ≥ 2 that are clinically indicated for surgical intervention with Axis human tissue in the anterior, posterior, or combined (anterior and posterior) compartments at the institutions designated for this study.
Key inclusion criteria (4 listed)
- Adult female at least 18 years of age.
- Willing and able to provide written informed consent.
- Confirmed pelvic organ prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading requiring surgical intervention in the anterior, posterior or combined (anterior and posterior) compartment.
- Willing and able to complete all follow-up visits and procedures indicated in this protocol.
Key exclusion criteria (8 listed)
- Concurrent surgical treatment of pelvic organ prolapse using anything other than the Axis Dermis.[Note: concurrent mid-urethral sling placement for treatment of stress urinary incontinence is allowed].
- Confirmed Stage 2 or higher prolapse as determined by POP-Q prolapse grading for a compartment that is not being repaired in the same procedure. (Concurrent POP-Q Stage 1 repair is at the physician's discretion.)
- Previous pelvic organ prolapse repair using biologic, or synthetic grafts. [Note: previous mid-urethral sling for treatment of stress urinary incontinence is allowed]
- Pregnant or a desire to become pregnant in the future.
- Previous radiation or other treatments for cancer in the pelvic area.
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 |
|---|---|---|
| AxisColoplast's Axis™ Allograft Dermis is used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair. | Other | AXIS Allograft Dermis |
Primary outcome
Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline and One Year.
Time frame: 1 year
The Pelvic Organ Prolapse Quantification system (POP-Q) is used to measure pelvic organ prolapse. POP-Q Stages are: Stage 0: No prolapse is demonstrated Stage 1: The criteria for stage 0 are not met, but the most distal portion of the prolapse is greater than 1 cm above the level of the hymen Stage 2: The most distal portion of the prolapse is greater than or equal to 1 centimeter proximal to or distal to the plane of the hymen Stage 3: The most distal portion of the prolapse is greater than 1 centimeter below the plan of the hymen but protrudes no further than 2 centimeters less that the total vaginal length in centimeters Stage 4: The distal portion of the prolapse protrudes to at least (TVL-2) centimeters. Improvement at one year is categorized as follows: Cured: Pop-Q Stage reduced to 0 or 1, or improved by 2 stages from baseline Improved: POP-Q Stage > 1, but improved by 1 stage from baseline Failed: POP-Q Stage stayed the same or increased in severity from baseline
17 secondary outcomes
Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline and Six Weeks
Time frame: 6 weeks
Percentage of Participants With POP-Q Stage Improvement After POP Repair With Axis Assessed by POP-Q Stage Improvement Based Upon Prolapse Grading of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Between Baseline and Six Months
Time frame: 6 months
Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline at 24 Months
Time frame: 24 months
Percentage of Participants With POP-Q Stage Improvement After POP Repair With Axis Assessed by POP-Q Stage Improvement Based Upon Prolapse Grading of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Between Baseline at 36 Months
Time frame: 36 months
Change in Participant Sexual Satisfaction From Baseline After Pelvic Organ Prolapse Repair With Axis Allograft Dermis Measured by Participant Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) at 6 Months
Time frame: Baseline and 6 months
Change in Patient Sexual Satisfaction From Baseline After Pelvic Organ Prolapse Repair With Axis Allograft Dermis Measured by Participant Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) at 12 Months
Time frame: Baseline and 12 months
Change in Patient Sexual Satisfaction From Baseline After Pelvic Organ Prolapse Repair With Axis Allograft Dermis Measured by Participant Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) at 24 Months
Time frame: Baseline and 24 months
Change in Patient Sexual Satisfaction From Baseline After Pelvic Organ Prolapse Repair With Axis Allograft Dermis Measured by Participant Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) at 36 Months
Time frame: Baseline and 36 months
Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 12 Months
Time frame: 12 months
Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 24 Months
Time frame: 24 month
Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 36 Months
Time frame: 36 months
Change in Pelvic/Bladder Pain With Daily Activity Visual Analog Scale (VAS) Questionnaire From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, 36 Months
Time frame: Baseline and 6 weeks, 6 months, 12 months, 24 months, 36 months
Change in Pelvic/Bladder Pain With Sexual Activity Visual Analog Scale (VAS) Questionnaire From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, 36 Months
Time frame: Baseline and 6 weeks, 6 months, 1 year, 2 years, 3 years
Percentage of Participants Who Had Surgical Revision of the Index Prolapse Compartment(s) After Pelvic Organ Prolapse Repair With Axis
Time frame: 3 year
Ratings for the Validated Surgical Satisfaction Questionnaire (SSQ-8) in Women Following Surgery to Correct Pelvic Organ Prolapse Repair With Axis Allograft Dermis at the 6 Week, 6 Month, 12 Month, 24 Month, and 36 Month Visits.
Time frame: 6 week, 6 month, 12 month, 24 month, and 36 month visits
Change in Pelvic Floor Distress Inventory (PFDI-20) Questionnaire After Pelvic Organ Prolapse Repair With Axis Allograft Dermis From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, and 36 Months
Time frame: Baseline and 6 weeks, 6 months, 12 Months, 24 Months, 36 Months
Change in the Participants Response on the Pelvic Floor Impact Questionnaire (PFIQ) From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, 36 Months
Time frame: Baseline and 6 weeks, 6 months, 12 Months, 24 Months, 36 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kristine Whitmore, MD principal investigator
Virtua Female Pelvic Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Coloplast A/S at 5 sites 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 4 inclusion and 8 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 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 18 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline and One Year. (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 30 Jun 2020.