Pelvic Organ ProlapseNCT01648751
Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
A study testing Vaginal estrogen in people with Pelvic Organ Prolapse, run by Pamela Moalli at 1 site in United States.
Trial summary
This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment leads to improvement in clinical outcomes. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Vaginal estrogen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 2 Mar 2023
- Phase
- Interventional
- 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 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women in good health aged 40-80
- Has symptoms of pelvic organ prolapse; answers yes to at least 1 of the following questions:
- Do you feel or see a vaginal bulge? Do you feel pressure in the vagina?
- Meets POP-Q criteria on exam for stage I, II, or III prolapse
- Interested in PFPT for management of POP
- Normal mammogram within 1 year of enrollment
Who cannot join
- Prior surgery for prolapse or incontinence
- Other prior interventions for prolapse (e.g. pessary, PFPT)
- Previous bilateral salpingo-oophorectomy (women with 1 ovary will be eligible)
- Known liver dysfunction
- Connective tissue diseases known to affect collagen or elastin remodeling (including: Lupus, Rheumatoid Arthritis, Scleroderma, Sjogrens syndrome, Marfan syndrome, and Ehlers-Danlos syndrome)
- Unevaluated abnormal vaginal bleeding or abnormal pap smear in the previous year
Show all 10Show fewer
- BMI > 35 kg/m2
- Estrogen therapy (including birth control) in the previous year
- Current or prior breast or pelvic malignancy (ovarian, tubal, uterine, cervical or vaginal)
- Contraindication to hormone use (i.e. thromboembolic disorder, use of anti-coagulants, coronary artery disease, history of stroke)
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Impact of Vaginal Estrogen in the Treatment of Symptomatic Mild Pelvic Organ Prolapse With Pelvic Floor Physical Therapy
This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment leads to improvement in clinical outcomes. The investigators predict that PFPT in combination with vaginal estrogen will lead to decreased pelvic floor symptoms and improved anatomical support corroborated by biomarker data.
Read the detailed description
The pathogenesis of pelvic organ prolapse (POP) is unknown. Few studies have correlated patient symptoms and amount of prolapse with biomarkers. POP has traditionally been managed with a pessary or surgery. Recent studies suggest a reduction in POP symptoms following Pelvic Floor Physical Therapy (PFPT). Vaginally delivered hormones are also commonly used to treat prolapse symptoms, with little evidence supporting a clinical benefit. The investigators hypothesize that the optimal approach to improving prolapse symptoms in the patient with mild prolapse requires re-alignment and strengthening of levator muscles via PFPT, and optimization of tissue integrity via local estrogen therapy. The investigators propose to test this hypothesis in a randomized controlled trial in which women with symptomatic mild prolapse opting for PFPT, receive treatment with PFPT in combination with vaginal estrogen versus placebo. The investigators predict that the combined approach will lead to decreased symptoms and improved anatomical support corroborated by biomarker data.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Vaginal estrogen, Placebo
- Keywords
- Pelvic organ prolapse, Pelvic floor physical therapy, Vaginal estrogen, Placebo
- 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.
Vaginal estrogenDrug
Also called Premarin vaginal cream
1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
PlaceboDrug
Also called Placebo cream
1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
| Study group | Role | What they receive |
|---|---|---|
| Vaginal estrogen | Experimental | Patients in the experimental group will receive vaginal estrogen cream Receives: Drug: Vaginal estrogen |
| Placebo cream | Placebo comparator | Patients in the comparison group will receive placebo vaginal cream Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Impression of Improvement
The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians.
Potential Responses:
- Very Much Better
- Much Better
- A Little Better
- No Change 5, A Little Worse
- Much Worse 7. Very Much Worse Lower scores indicate more imiprovment / better outcome.
Measured: 6 months after starting vaginal cream
Secondary outcomes (5)
Pelvic Floor Symptoms
Pelvic Floor Symptoms, using the PFDI-20. The Pelvic Floor Distress Inventory is a condition specific quality of life instrument that assesses distress from pelvic organ prolapse, colorectal-anal, and urinary symptoms.
Higher scores indicate greater disease burden. Range: 0 to 300
Measured: 6 months
General Quality of Life
Quality of Life, using the PFIQ-7 The Pelvic Floor Impact Questionnaire assesses how bladder, bowel, and vaginal symptoms affect activity, relationships, ad feelings.
Higher numbers indicate greater disease burden. Score range: 0 to 300
Measured: 6 months
Pelvic Organ Prolapse Stage
Pelvic Organ Prolapse Stage, using the POP-Q exam. The Pelvic Organ Prolapse Quantification System use 9 measurements in the vagina to assess prolapse stage.
Higher stage indicates greater prolapse. Range: 0 to 4
Measured: 6 months
Collagenase Activity
Collagenase Activity, via vaginal swabs collected from the posterior fornix will be used for biochemical analysis.
Measured: 6 months
Sexual Function
Sexual Function, using the PISQ-12 The Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire evaluates sexual function in patients with incontinence and/or vaginal prolapse.
Higher scores indicate greater disease burden. Scale: 0 to 48
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startMay 2012
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
Why it stopped: Insufficient recruitment
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamela Moalli
- Sponsor type
- University, hospital or other
- Collaborators
- American Urogynecologic Society, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Pfizer
- Responsible party
- Sponsor-investigator, Pamela Moalli, University of Pittsburgh
- Investigators
- Laura C Skoczylas, MD, MS, Study director, University of PittsburghPamela Moalli, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648751
- Sponsor's protocol ID
- STUDY19030408
- Other IDs
- R01HD061811
- Status last verified
- Sep 2024
- First submitted
- 19 Jul 2012
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vaginal Estrogen in the Treatment of Symptomatic Mild Pelvic Organ Prolapse With Pelvic Floor Physical Therapy
- ClinicalTrials.gov ID
- NCT01648751
- Acronym / sponsor ID
- STUDY19030408
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic organ prolapse, Pelvic floor physical therapy, Vaginal estrogen, Placebo
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Pamela MoalliUniversity, hospital or other
- Collaborators
- American Urogynecologic Society, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Pfizer
- Study start
- May 2012
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment leads to improvement in clinical outcomes. The investigators predict that PFPT in combination with vaginal estrogen will lead to decreased pelvic floor symptoms and improved anatomical support corroborated by biomarker data.
Detailed description
The pathogenesis of pelvic organ prolapse (POP) is unknown. Few studies have correlated patient symptoms and amount of prolapse with biomarkers. POP has traditionally been managed with a pessary or surgery. Recent studies suggest a reduction in POP symptoms following Pelvic Floor Physical Therapy (PFPT). Vaginally delivered hormones are also commonly used to treat prolapse symptoms, with little evidence supporting a clinical benefit. The investigators hypothesize that the optimal approach to improving prolapse symptoms in the patient with mild prolapse requires re-alignment and strengthening of levator muscles via PFPT, and optimization of tissue integrity via local estrogen therapy. The investigators propose to test this hypothesis in a randomized controlled trial in which women with symptomatic mild prolapse opting for PFPT, receive treatment with PFPT in combination with vaginal estrogen versus placebo. The investigators predict that the combined approach will lead to decreased symptoms and improved anatomical support corroborated by biomarker data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal estrogen | Experimental | Drug: Vaginal estrogenPatients in the experimental group will receive vaginal estrogen cream |
| Placebo cream | Placebo comparator | Drug: PlaceboPatients in the comparison group will receive placebo vaginal cream |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women in good health aged 40-80
- Has symptoms of pelvic organ prolapse; answers yes to at least 1 of the following questions:
- Do you feel or see a vaginal bulge? Do you feel pressure in the vagina?
- Meets POP-Q criteria on exam for stage I, II, or III prolapse
- Interested in PFPT for management of POP
Key exclusion criteria (10 listed)
- Prior surgery for prolapse or incontinence
- Other prior interventions for prolapse (e.g. pessary, PFPT)
- Previous bilateral salpingo-oophorectomy (women with 1 ovary will be eligible)
- Known liver dysfunction
- Connective tissue diseases known to affect collagen or elastin remodeling (including: Lupus, Rheumatoid Arthritis, Scleroderma, Sjogrens syndrome, Marfan syndrome, and Ehlers-Danlos syndrome)
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 |
|---|---|---|
| Vaginal estrogenAlso: Premarin vaginal cream1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter | Drug | Vaginal estrogen |
| PlaceboAlso: Placebo cream1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter | Drug | Placebo cream |
Primary outcome
Patient Global Impression of Improvement
Time frame: 6 months after starting vaginal cream
The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians. Potential Responses: 1. Very Much Better 2. Much Better 3. A Little Better 4. No Change 5, A Little Worse 6. Much Worse 7. Very Much Worse Lower scores indicate more imiprovment / better outcome.
5 secondary outcomes
Pelvic Floor Symptoms
Time frame: 6 months
General Quality of Life
Time frame: 6 months
Pelvic Organ Prolapse Stage
Time frame: 6 months
Collagenase Activity
Time frame: 6 months
Sexual Function
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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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.
Laura C Skoczylas, MD, MS study director
University of Pittsburgh
Pamela Moalli, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal estrogen in people with Pelvic Organ Prolapse, run by Pamela Moalli 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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. Some participants in this study may receive a placebo. 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 19 Sep 2024). 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?
Patient Global Impression of Improvement (time frame: 6 months after starting vaginal cream). 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 Sep 2024.