Trial · NCT01648751
Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
NCT01648751, Not applicable, Terminated, Pamela Moalli; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse. Trials, record NCT01648751. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01648751
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
- NCT number
- NCT01648751
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 21 participants, actual
- Lead sponsor
- Pamela Moalli
- Conditions
- Pelvic Organ Prolapse
- Interventions
- Vaginal estrogen, Placebo
- First posted
- 2012-07-24
- Last updated
- 2024-09-19
- Results first posted
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient Global Impression of Improvement | 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. |
| Secondary | Pelvic Floor Symptoms | 6 months | 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 |
| Secondary | General Quality of Life | 6 months | 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 |
| Secondary | Pelvic Organ Prolapse Stage | 6 months | 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 |
| Secondary | Collagenase Activity | 6 months | Collagenase Activity, via vaginal swabs collected from the posterior fornix will be used for biochemical analysis. |
| Secondary | Sexual Function | 6 months | 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 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patient Global Impression of Improvement | 6 months after starting vaginal cream | Subjects who completed surveys at 6 months post treatment. | score on a scale | MEAN |
| SECONDARY | Pelvic Floor Symptoms | 6 months | Subjects who completed surveys at 6 months post treatment. | score on a scale | MEAN |
| SECONDARY | General Quality of Life | 6 months | Subjects who completed surveys at 6 months post treatment. | score on a scale | MEAN |
| SECONDARY | Pelvic Organ Prolapse Stage | 6 months | Subjects who underwent POP-Q measurements at 6 months post treatment. | units on a scale | MEAN |
| SECONDARY | Collagenase Activity | 6 months | Data not available. Vaginal swabs were collected from participants. However, the lab was unable to analyze collagenase activity because there was not enough protein isolated from the samples. | ||
| SECONDARY | Sexual Function | 6 months | Subjects who completed surveys at 6 months post treatment. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient Global Impression of Improvement | Vaginal Estrogen | 2.3 | Full Range 1 to 3 | score on a scale | |
| Patient Global Impression of Improvement | Placebo Cream | 3.0 | Full Range 1 to 5 | score on a scale | |
| Pelvic Floor Symptoms | Vaginal Estrogen | 16.9 | Full Range 0 to 36 | score on a scale | |
| Pelvic Floor Symptoms | Placebo Cream | 48 | Full Range 0 to 130 | score on a scale | |
| General Quality of Life | Vaginal Estrogen | 6.1 | Full Range 0 to 24 | score on a scale | |
| General Quality of Life | Placebo Cream | 19.9 | Full Range 0 to 76 | score on a scale | |
| Pelvic Organ Prolapse Stage | Vaginal Estrogen | 2 | Full Range 1 to 3 | units on a scale | |
| Pelvic Organ Prolapse Stage | Placebo Cream | 2 | Full Range 1 to 3 | units on a scale | |
| Sexual Function | Vaginal Estrogen | 12.8 | Full Range 7 to 26 | score on a scale | |
| Sexual Function | Placebo Cream | 14 | Full Range 5 to 23 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vaginal Estrogen | 9 | |
| Overall Study | STARTED | Placebo Cream | 11 | |
| Overall Study | COMPLETED | Vaginal Estrogen | 7 | |
| Overall Study | COMPLETED | Placebo Cream | 8 | |
| Overall Study | NOT COMPLETED | Vaginal Estrogen | 2 | |
| Overall Study | NOT COMPLETED | Placebo Cream | 3 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vaginal Estrogen | 0 | 9 |
| Total, all-cause mortality | Placebo Cream | 0 | 11 |
| Total, other adverse events | Vaginal Estrogen | 0 | 9 |
| Total, other adverse events | Placebo Cream | 0 | 11 |
| Total, serious adverse events | Vaginal Estrogen | 0 | 9 |
| Total, serious adverse events | Placebo Cream | 0 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD061811 | Comprehensive Evaluation of Prolapse Meshes by an Interdisciplinary Research Team | MOALLI, PAMELA A. | MAGEE-WOMEN'S RES INST AND FOUNDATION | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2009 to 2013 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vaginal Estrogen vs Placebo Cream: deaths from any cause | Trial comparisons |
| Vaginal Estrogen vs Placebo Cream: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01648751
GET https://conductscience.org/api/trials/v1/NCT01648751/registered