Trial Outcomes & Findings for Vaginal Diazepam for the Treatment of Female Pelvic Pain (NCT NCT01938092)
NCT ID: NCT01938092
Last Updated: 2024-09-03
Results Overview
Ten centimeter (100 mm) linear pain scale where patients mark their self-perceived level of pain on a paper with a 10 cm line indicating that the 0 cm position indicates no pain and the 10 cm position indicates the worst pain imaginable. The score is measured as the distance between the zero position and the patient's mark is measured in cm to the nearest mm. A higher score indicates a worse outcome. The change in pain score is calculated by from the value at baseline minus the value at 4 weeks. Potential range is -100 to 100, with a higher value indicating a better outcome.
COMPLETED
PHASE2
50 participants
Baseline and 4 weeks
2024-09-03
Participant Flow
urogynecology outpatient clinic patients sequentially enrolled September 2013-August 2016. Inclusion: 18+ years of age with primary complaint of acute or chronic pelvic pain, with or without dyspareunia, and hypertonicity of the levator muscles. Exclusion: pregnant, breastfeeding, previous pelvic floor therapy, contraindication to denzodiazepines
Participant milestones
| Measure |
Diazepam
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Diazepam
|
Placebo
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prolapse data unavailable for 1 diazepam and 2 placebo participants
Baseline characteristics by cohort
| Measure |
Diazepam
n=25 Participants
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Diazepam
|
Placebo
n=24 Participants
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Placebo
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=25 Participants
|
42 years
n=24 Participants
|
42 years
n=49 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=25 Participants
|
24 Participants
n=24 Participants
|
49 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=25 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=49 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=25 Participants
|
22 Participants
n=24 Participants
|
45 Participants
n=49 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=49 Participants
|
|
Body Mass Index
|
27.07 kg/m^2
n=25 Participants
|
26.99 kg/m^2
n=24 Participants
|
27.07 kg/m^2
n=49 Participants
|
|
Gravida
|
2 number of pregnancies
n=25 Participants
|
2 number of pregnancies
n=24 Participants
|
2 number of pregnancies
n=49 Participants
|
|
Term Pregnancies
|
2 number of full-term pregnancies
n=25 Participants
|
2 number of full-term pregnancies
n=24 Participants
|
2 number of full-term pregnancies
n=49 Participants
|
|
Cesarean sections
|
0 number of cesarean sections
n=25 Participants
|
0 number of cesarean sections
n=24 Participants
|
0 number of cesarean sections
n=49 Participants
|
|
Vaginal deliveries
|
1 number of vaginal deliveries
n=25 Participants
|
1 number of vaginal deliveries
n=24 Participants
|
1 number of vaginal deliveries
n=49 Participants
|
|
Largest baby
|
3713 gm
n=25 Participants
|
3487 gm
n=24 Participants
|
3642 gm
n=49 Participants
|
|
Symptom duration
|
24 months
n=25 Participants
|
30 months
n=24 Participants
|
24 months
n=49 Participants
|
|
Post void residual
|
20 mL
n=25 Participants
|
35 mL
n=24 Participants
|
25 mL
n=49 Participants
|
|
Prolapse
|
4 participants
n=24 Participants • Prolapse data unavailable for 1 diazepam and 2 placebo participants
|
4 participants
n=22 Participants • Prolapse data unavailable for 1 diazepam and 2 placebo participants
|
8 participants
n=46 Participants • Prolapse data unavailable for 1 diazepam and 2 placebo participants
|
|
diabetes mellitus
|
3 Participants
n=25 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=49 Participants
|
|
Cardiovascular disease
|
2 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=49 Participants
|
|
Lung disease
|
2 Participants
n=25 Participants
|
5 Participants
n=24 Participants
|
7 Participants
n=49 Participants
|
|
Low back pain
|
13 Participants
n=25 Participants
|
10 Participants
n=24 Participants
|
23 Participants
n=49 Participants
|
|
Gastrointestinal disease
|
8 Participants
n=25 Participants
|
11 Participants
n=24 Participants
|
19 Participants
n=49 Participants
|
|
Headache
|
11 Participants
n=25 Participants
|
11 Participants
n=24 Participants
|
22 Participants
n=49 Participants
|
|
Neurological disease
|
1 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=49 Participants
|
|
Anxiety
|
10 Participants
n=25 Participants
|
16 Participants
n=24 Participants
|
26 Participants
n=49 Participants
|
|
Depression
|
9 Participants
n=25 Participants
|
14 Participants
n=24 Participants
|
23 Participants
n=49 Participants
|
|
Bipolar disorder
|
2 Participants
n=25 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=49 Participants
|
|
Obsterical trauma
|
10 Participants
n=25 Participants
|
12 Participants
n=24 Participants
|
22 Participants
n=49 Participants
|
|
Menopausal
|
12 Participants
n=25 Participants
|
11 Participants
n=24 Participants
|
23 Participants
n=49 Participants
|
|
Current hormone replacement therapy
|
2 Participants
n=25 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=49 Participants
|
|
Vaginal estrogen use
|
8 Participants
n=25 Participants
|
3 Participants
n=24 Participants
|
11 Participants
n=49 Participants
|
|
Hysterectomy
|
9 Participants
n=25 Participants
|
8 Participants
n=24 Participants
|
17 Participants
n=49 Participants
|
|
Mesh surgery
|
5 Participants
n=25 Participants
|
4 Participants
n=24 Participants
|
9 Participants
n=49 Participants
|
|
Smoker
|
9 Participants
n=25 Participants
|
8 Participants
n=24 Participants
|
17 Participants
n=49 Participants
|
|
Heavy lifting
|
4 Participants
n=25 Participants
|
7 Participants
n=24 Participants
|
11 Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: After randomization, 25 patients on diazepam treatment and 24 patients on placebo provided baseline values for visual analog score (VAS) for pain. At 4 weeks treatment, 19 patients in the diazepam group and 16 patients in the placebo group provided VAS data for pain. Data from the latter group of 35 patients were analyzed.
Ten centimeter (100 mm) linear pain scale where patients mark their self-perceived level of pain on a paper with a 10 cm line indicating that the 0 cm position indicates no pain and the 10 cm position indicates the worst pain imaginable. The score is measured as the distance between the zero position and the patient's mark is measured in cm to the nearest mm. A higher score indicates a worse outcome. The change in pain score is calculated by from the value at baseline minus the value at 4 weeks. Potential range is -100 to 100, with a higher value indicating a better outcome.
Outcome measures
| Measure |
Diazepam
n=19 Participants
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Diazepam
|
Placebo
n=16 Participants
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Placebo
|
|---|---|---|
|
Visual Analog Scale (VAS) for Pain
|
50 score on a scale
Interval 20.0 to 75.0
|
39 score on a scale
Interval 5.0 to 55.0
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: After randomization, 25 patients on diazepam treatment and 24 patients on placebo provided baseline values for the pelvic floor distress inventory-20 (PFDI-20) questionnaire. At 4 weeks treatment, 19 patients in the diazepam group and 16 patients in the placebo group provided PFDI-20 questionnaire data. Data from the latter group of 35 patients were analyzed.
The Pelvic Floor Distress Inventory-20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms. Includes 20 questions and 3 scales. Each of the 3 scales is scored from a minimum score of 0 (least distress) to a maximum of 100 (greatest distress), thus a higher score indicates a poorer outcome. The scores from each of the 3 scales are added together to give a summary score (range 0 to 300). The PFDI-20 questionnaire was administered at baseline and at 4 weeks of treatment. The outcome was the score at 4 weeks of treatment.
Outcome measures
| Measure |
Diazepam
n=19 Participants
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Diazepam
|
Placebo
n=16 Participants
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Placebo
|
|---|---|---|
|
Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks.
|
96 score on a scale
Interval 56.0 to 116.0
|
107 score on a scale
Interval 45.0 to 164.0
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: After randomization, 25 patients on diazepam treatment and 24 patients on placebo provided baseline values for the McGill pain questionnaire. At 4 weeks treatment, 19 patients in the diazepam group and 16 patients in the placebo group provided McGill pain questionnaire data. Data from the latter group of 35 patients were analyzed.
The McGilll pain questionnaire is a validated instrument that assigns quantitative value to qualitative descriptions of chosen by the patient. The minimum pain score is 0 (would not be seen in a person with true pain) and the maximum pain score: 78. The higher the pain score the greater the pain and the poorer the outcome. measured at 4 weeks.
Outcome measures
| Measure |
Diazepam
n=25 Participants
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Diazepam
|
Placebo
n=24 Participants
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Placebo
|
|---|---|---|
|
McGill Pain Questionnaire Score (PRI) at 4 Weeks
|
34 score on a scale
Interval 28.0 to 38.0
|
33 score on a scale
Interval 21.0 to 41.0
|
Adverse Events
Diazepam
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diazepam
n=25 participants at risk
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Diazepam
|
Placebo
n=24 participants at risk
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Placebo
|
|---|---|---|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 1 • 4 weeks
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
|
Nervous system disorders
drowsiness
|
4.0%
1/25 • Number of events 1 • 4 weeks
|
4.2%
1/24 • Number of events 1 • 4 weeks
|
|
Product Issues
site irritation
|
8.0%
2/25 • Number of events 2 • 4 weeks
|
8.3%
2/24 • Number of events 2 • 4 weeks
|
Additional Information
Erma Z. Drobnis, Associate Director, Research Success Center
University of Missouri-Columibia, Dept. Ob/Gyn
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place