Trial Outcomes & Findings for Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection (NCT NCT04301934)
NCT ID: NCT04301934
Last Updated: 2024-03-26
Results Overview
Prevalence of urinary tract infections (UTI) described as percentage of subjects with none vs one or more UTI.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
4 months
Results posted on
2024-03-26
Participant Flow
Participant milestones
| Measure |
Vaginal Estrogen Therapy Group
Women randomized to vaginal estrogen therapy were offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly
Conjugated estrogen: Current standard treatment for recurrent UTIs in postmenopausal women
Estradiol: Current standard treatment for recurrent Urinary Tract Infections (UTI) in postmenopausal women
|
Laser Therapy Group
Women randomized to the laser therapy group underwent 3 treatments, 6 weeks apart.
Mona Lisa Touch: Fractional CO2 LASER
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection
Baseline characteristics by cohort
| Measure |
Vaginal Estrogen Therapy Group
n=7 Participants
Women randomized to vaginal estrogen therapy were offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly
Conjugated estrogen: Current standard treatment for recurrent UTIs in postmenopausal women
Estradiol: Current standard treatment for recurrent UTIs in postmenopausal women
|
Laser Therapy Group
n=5 Participants
Women randomized to the laser therapy group underwent 3 treatments, 6 weeks apart.
Mona Lisa Touch: Fractional CO2 LASER
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 6.41 • n=5 Participants
|
69.1 years
STANDARD_DEVIATION 9.47 • n=7 Participants
|
68.0 years
STANDARD_DEVIATION 7.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPrevalence of urinary tract infections (UTI) described as percentage of subjects with none vs one or more UTI.
Outcome measures
| Measure |
Vaginal Estrogen Therapy Group
n=7 Participants
Women randomized to vaginal estrogen therapy were offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly
Conjugated estrogen: Current standard treatment for recurrent UTIs in postmenopausal women
Estradiol: Current standard treatment for recurrent UTIs in postmenopausal women
|
Laser Therapy Group
n=5 Participants
Women randomized to the laser therapy group underwent 3 treatments, 6 weeks apart.
Mona Lisa Touch: Fractional CO2 LASER
|
|---|---|---|
|
Prevalence of Urinary Tract Infections (UTI)
No UTI
|
28.6 percentage of subjects
|
60 percentage of subjects
|
|
Prevalence of Urinary Tract Infections (UTI)
1 + UTI
|
71.4 percentage of subjects
|
40 percentage of subjects
|
Adverse Events
Vaginal Estrogen Therapy Group
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Laser Therapy Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vaginal Estrogen Therapy Group
n=7 participants at risk
Women randomized to vaginal estrogen therapy were offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly
Conjugated estrogen: Current standard treatment for recurrent UTIs in postmenopausal women
Estradiol: Current standard treatment for recurrent UTIs in postmenopausal women
|
Laser Therapy Group
n=5 participants at risk
Women randomized to the laser therapy group underwent 3 treatments, 6 weeks apart.
Mona Lisa Touch: Fractional CO2 LASER
|
|---|---|---|
|
Renal and urinary disorders
Urospepsis with positive urine and blood cultures
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
0.00%
0/5 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
|
Gastrointestinal disorders
Acute diverticulitis
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
0.00%
0/5 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
Other adverse events
| Measure |
Vaginal Estrogen Therapy Group
n=7 participants at risk
Women randomized to vaginal estrogen therapy were offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly
Conjugated estrogen: Current standard treatment for recurrent UTIs in postmenopausal women
Estradiol: Current standard treatment for recurrent UTIs in postmenopausal women
|
Laser Therapy Group
n=5 participants at risk
Women randomized to the laser therapy group underwent 3 treatments, 6 weeks apart.
Mona Lisa Touch: Fractional CO2 LASER
|
|---|---|---|
|
Vascular disorders
Thrombophlebitis
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
0.00%
0/5 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
|
Renal and urinary disorders
Urinary tract infection
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
0.00%
0/5 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
|
Reproductive system and breast disorders
Vaginal irritation
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
|
Reproductive system and breast disorders
Abnormal bleeding
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
40.0%
2/5 • Number of events 5 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
|
Reproductive system and breast disorders
Increase vaginal discharge
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
|
Reproductive system and breast disorders
Vaginal burning
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
40.0%
2/5 • Number of events 3 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
|
Reproductive system and breast disorders
Vaginal itching
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
20.0%
1/5 • Number of events 3 • Adverse Events were collected from baseline to end of study, approximately 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place