Trial Outcomes & Findings for Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse (NCT NCT01648751)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

6 months after starting vaginal cream

Results posted on

2024-09-19

Participant Flow

One subject was ineligible prior to randomization.

Participant milestones

Participant milestones
Measure	Vaginal Estrogen Patients in the experimental group will receive vaginal estrogen cream Vaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter	Placebo Cream Patients in the comparison group will receive placebo vaginal cream Placebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
Overall Study STARTED	9	11
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Vaginal Estrogen Patients in the experimental group will receive vaginal estrogen cream Vaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter	Placebo Cream Patients in the comparison group will receive placebo vaginal cream Placebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaginal Estrogen n=9 Participants Patients in the experimental group will receive vaginal estrogen cream Vaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter	Placebo Cream n=11 Participants Patients in the comparison group will receive placebo vaginal cream Placebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=11 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=9 Participants	9 Participants n=11 Participants	17 Participants n=20 Participants
Age, Categorical >=65 years	1 Participants n=9 Participants	2 Participants n=11 Participants	3 Participants n=20 Participants
Sex: Female, Male Female	9 Participants n=9 Participants	11 Participants n=11 Participants	20 Participants n=20 Participants
Sex: Female, Male Male	0 Participants n=9 Participants	0 Participants n=11 Participants	0 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=9 Participants	11 participants n=11 Participants	20 participants n=20 Participants

PRIMARY outcome

Timeframe: 6 months after starting vaginal cream

Population: Subjects who completed surveys at 6 months post treatment.

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.

Outcome measures

Outcome measures
Measure	Vaginal Estrogen n=7 Participants Patients in the experimental group will receive vaginal estrogen cream Vaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter. The average score on the PGI-I at 6 months post treatment was 2.3. (N=7) A lower score on the PGI-I indicates improvement.	Placebo Cream n=7 Participants Patients in the comparison group will receive placebo vaginal cream Placebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter. The average score on the PGI-I at 6 months post treatment was 3.0. (N=7) A lower score indicates improvement.
Patient Global Impression of Improvement	2.3 score on a scale Interval 1.0 to 3.0	3.0 score on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: 6 months

Population: Subjects who completed surveys at 6 months post treatment.

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

Outcome measures

Outcome measures
Measure	Vaginal Estrogen n=7 Participants Patients in the experimental group will receive vaginal estrogen cream Vaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter. The average score on the PGI-I at 6 months post treatment was 2.3. (N=7) A lower score on the PGI-I indicates improvement.	Placebo Cream n=7 Participants Patients in the comparison group will receive placebo vaginal cream Placebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter. The average score on the PGI-I at 6 months post treatment was 3.0. (N=7) A lower score indicates improvement.
Pelvic Floor Symptoms	16.9 score on a scale Interval 0.0 to 36.0	48 score on a scale Interval 0.0 to 130.0

SECONDARY outcome

Timeframe: 6 months

Population: Subjects who completed surveys at 6 months post treatment.

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

Outcome measures

Outcome measures
Measure	Vaginal Estrogen n=7 Participants Patients in the experimental group will receive vaginal estrogen cream Vaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter. The average score on the PGI-I at 6 months post treatment was 2.3. (N=7) A lower score on the PGI-I indicates improvement.	Placebo Cream n=7 Participants Patients in the comparison group will receive placebo vaginal cream Placebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter. The average score on the PGI-I at 6 months post treatment was 3.0. (N=7) A lower score indicates improvement.
General Quality of Life	6.1 score on a scale Interval 0.0 to 24.0	19.9 score on a scale Interval 0.0 to 76.0

SECONDARY outcome

Timeframe: 6 months

Population: Subjects who underwent POP-Q measurements at 6 months post treatment.

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

Outcome measures

Outcome measures
Measure	Vaginal Estrogen n=8 Participants Patients in the experimental group will receive vaginal estrogen cream Vaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter. The average score on the PGI-I at 6 months post treatment was 2.3. (N=7) A lower score on the PGI-I indicates improvement.	Placebo Cream n=7 Participants Patients in the comparison group will receive placebo vaginal cream Placebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter. The average score on the PGI-I at 6 months post treatment was 3.0. (N=7) A lower score indicates improvement.
Pelvic Organ Prolapse Stage	2 units on a scale Interval 1.0 to 3.0	2 units on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: 6 months

Population: 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.

Collagenase Activity, via vaginal swabs collected from the posterior fornix will be used for biochemical analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Subjects who completed surveys at 6 months post treatment.

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

Outcome measures

Outcome measures
Measure	Vaginal Estrogen n=7 Participants Patients in the experimental group will receive vaginal estrogen cream Vaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter. The average score on the PGI-I at 6 months post treatment was 2.3. (N=7) A lower score on the PGI-I indicates improvement.	Placebo Cream n=6 Participants Patients in the comparison group will receive placebo vaginal cream Placebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter. The average score on the PGI-I at 6 months post treatment was 3.0. (N=7) A lower score indicates improvement.
Sexual Function	12.8 score on a scale Interval 7.0 to 26.0	14 score on a scale Interval 5.0 to 23.0

Adverse Events

Vaginal Estrogen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pamela Moalli MD PHD

University of PIttsburgh

Phone: 412-641-6052

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place