Trial Outcomes & Findings for A Pilot Study Investigating the Use of a Therapeutic Wand in Addition to Physiotherapy for Bladder Pain Syndrome (NCT NCT02743962)

Results Overview

Single page questionnaire of bladder symptoms and rating of bother. This outcome measure has 4 questions and scores for each question range from 0 to 4 or 5. The total achievable in this outcome measure is a score of between 0 to 19. A higher score describes greater symptoms of Interstitial Cystitis. Total scores were collected for analysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Baseline to 6 weeks and 6 to 12 weeks

Results posted on

2018-05-03

Participant Flow

Urology and Urogynaecology consultants' secretaries identified potential participants using a range of keywords and International Classification of Diseases (ICD-10) codes in April 2016. Potential participants attended a meeting at a single private hospital site and recruitment was completed by the end of May 2016.

There was no pre-participation period. Once consented to participate participants began the study.

Participant milestones

Participant milestones
Measure	Usual Physiotherapy Treatment Group This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. Routine physiotherapy control: Provision of routine physiotherapy care as control	Therapeutic Wand Group This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study.
Overall Study STARTED	5	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Physiotherapy Treatment Group This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. Routine physiotherapy control: Provision of routine physiotherapy care as control	Therapeutic Wand Group This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study.
Overall Study Atrophic vaginitis diagnosed	1	0

Baseline Characteristics

A Pilot Study Investigating the Use of a Therapeutic Wand in Addition to Physiotherapy for Bladder Pain Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Physiotherapy Treatment Group n=4 Participants This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period. Routine physiotherapy control: Provision of routine physiotherapy care as control	Therapeutic Wand Group n=5 Participants This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study.	Total n=9 Participants Total of all reporting groups
Age, Continuous	36.3 years STANDARD_DEVIATION 17.9 • n=5 Participants	32.6 years STANDARD_DEVIATION 7.2 • n=7 Participants	34.4 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United Kingdom	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
O'Leary-Sant Interstitial Cystitis Symptom Score	10.5 units on a scale STANDARD_DEVIATION 2.64 • n=5 Participants	12.4 units on a scale STANDARD_DEVIATION 2.07 • n=7 Participants	11.5 units on a scale STANDARD_DEVIATION 2.4 • n=5 Participants
O'Leary-Sant Interstitial Cystitis Problem Score	10 units on a scale STANDARD_DEVIATION 3.9 • n=5 Participants	11.2 units on a scale STANDARD_DEVIATION 2.7 • n=7 Participants	10.6 units on a scale STANDARD_DEVIATION 3.12 • n=5 Participants
Genito-Urinary Pain Index	27 units on a scale STANDARD_DEVIATION 7.1 • n=5 Participants	31 units on a scale STANDARD_DEVIATION 4.9 • n=7 Participants	29.2 units on a scale STANDARD_DEVIATION 5.9 • n=5 Participants
The Pelvic Pain and Urinary Frequency Patient Symptom Score	14 units on a scale STANDARD_DEVIATION 3.6 • n=5 Participants	16.2 units on a scale STANDARD_DEVIATION 1.6 • n=7 Participants	15.2 units on a scale STANDARD_DEVIATION 2.7 • n=5 Participants
Visual Analogue Scale of pain experienced on palpation of the pelvic floor muscles	7.25 units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants	8 units on a scale STANDARD_DEVIATION 0.7 • n=7 Participants	7.6 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants
Duration of BPS symptoms	4.25 Years STANDARD_DEVIATION 4.03 • n=5 Participants	5.2 Years STANDARD_DEVIATION 4.02 • n=7 Participants	4.8 Years STANDARD_DEVIATION 3.8 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 weeks and 6 to 12 weeks

Single page questionnaire of bladder symptoms and rating of bother. This outcome measure has 4 questions and scores for each question range from 0 to 4 or 5. The total achievable in this outcome measure is a score of between 0 to 19. A higher score describes greater symptoms of Interstitial Cystitis. Total scores were collected for analysis.

Outcome measures

Outcome measures
Measure	Usual Physiotherapy Treatment Group n=4 Participants This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period. Routine physiotherapy control: Provision of routine physiotherapy care as control	Therapeutic Wand Group n=5 Participants This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study.
Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score Change in ICSI score 0 to 6 weeks	-4.25 units on a scale Standard Deviation 0.95	-6.2 units on a scale Standard Deviation 0.83
Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score Change in ICSI score 6 to 12 weeks	0 units on a scale Standard Deviation 0.95	-1.8 units on a scale Standard Deviation 2.12

PRIMARY outcome

Timeframe: Baseline to 6 weeks and 6 to 12 weeks

Single page questionnaire of bladder symptoms and rating of bother. This outcome measure has 4 questions and scores for each question range from 0 to 4. The total achievable in this outcome measure is a score of between 0 to 16. A higher score describes greater burden of Interstitial Cystitis symptoms on the individual. Total scores were collected for analysis.

Outcome measures

Outcome measures
Measure	Usual Physiotherapy Treatment Group n=4 Participants This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period. Routine physiotherapy control: Provision of routine physiotherapy care as control	Therapeutic Wand Group n=5 Participants This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study.
Change in O'Leary-Sant Interstitial Cystitis Problem Index Score Change in ICPI 0 to 6 weeks	-3.5 units on a scale Standard Deviation 1.91	-5 units on a scale Standard Deviation 1.41
Change in O'Leary-Sant Interstitial Cystitis Problem Index Score Change in ICPI 6 to 12 weeks	-0.25 units on a scale Standard Deviation 1.29	-2 units on a scale Standard Deviation 0.70

SECONDARY outcome

Timeframe: 0 to 12 weeks

Single page questionnaire of genital pain and rating of perceived bother. This outcome measure has 9 questions, each has between 4 and 10 potential responses which are weighted differently, between 0 and 10 units. The total achievable in this outcome measure is a score of 45 and the least achievable is a score of 0. A higher score describes a higher perceived genital pain level and greater burden of symptoms on the individual. Total scores were collected for analysis.

Outcome measures

Outcome measures
Measure	Usual Physiotherapy Treatment Group n=4 Participants This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period. Routine physiotherapy control: Provision of routine physiotherapy care as control	Therapeutic Wand Group n=5 Participants This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study.
Change in Genitourinary Pain Index	-10.5 units on a scale Standard Deviation 4.04	-15 units on a scale Standard Deviation 6.25

SECONDARY outcome

Timeframe: 0 to 12 weeks

Single page questionnaire of urinary symptoms, sexual symptoms and perceived bother. This outcome measure has 12 questions, each has between 2 and 4 potential responses which are weighted between 0 and 4 units. The total achievable in this outcome measure is a score of 35 and the least achievable is a score of 0. A higher score describes a worse urinary symptoms, sexual symptoms and a greater burden of the symptoms on the individual. Total scores were collected for analysis at baseline and 12 weeks.

Outcome measures

Outcome measures
Measure	Usual Physiotherapy Treatment Group n=4 Participants This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period. Routine physiotherapy control: Provision of routine physiotherapy care as control	Therapeutic Wand Group n=5 Participants This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study.
Pelvic Pain and Urinary Urgency Frequency Patient Symptom Scale	-4.5 units on a scale Standard Deviation 2.64	-9 units on a scale Standard Deviation 2.83

SECONDARY outcome

Timeframe: Baseline to 12 weeks

This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived urinary urgency. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived urinary urgency. Patients mark along the score line to indicate their perceived urinary urgency. The number of millimeters from the 0 point was recorded as their score, for example "57mm". This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded.

Outcome measures

Outcome measures
Measure	Usual Physiotherapy Treatment Group n=4 Participants This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period. Routine physiotherapy control: Provision of routine physiotherapy care as control	Therapeutic Wand Group n=5 Participants This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study.
Change in Perceived Urinary Urgency	-30 units on a scale Standard Deviation 8.16	-48 units on a scale Standard Deviation 13.03

SECONDARY outcome

Timeframe: Baseline to 12 weeks

This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived overall pain. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived overall pain. Patients mark along the score line to indicate their perceived overall pain. The number of millimeters from the 0 point was recorded as their score, for example "57mm". This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded.

Outcome measures

Outcome measures
Measure	Usual Physiotherapy Treatment Group n=4 Participants This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period. Routine physiotherapy control: Provision of routine physiotherapy care as control	Therapeutic Wand Group n=5 Participants This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study.
Change in Perceived Overall Pain	-25 units on a scale Standard Deviation 10	-46 units on a scale Standard Deviation 16.73

SECONDARY outcome

Timeframe: 0 to 12 weeks

This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived ease of using a therapeutic wand. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived ease of therapeutic wand use. Patients mark along the score line to indicate their perceived ease of therapeutic wand use. The number of millimeters from the 0 point was recorded as their score, for example "57mm". This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded.

Outcome measures

Outcome measures
Measure	Usual Physiotherapy Treatment Group n=5 Participants This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period. Routine physiotherapy control: Provision of routine physiotherapy care as control	Therapeutic Wand Group This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study.
Perceived Ease of Therapeutic Wand Use	3.5 units on a scale Standard Deviation 0.95	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 to 12 weeks

Participant reports of adverse events will be recorded to inform development of the method

Outcome measures

Outcome measures
Measure	Usual Physiotherapy Treatment Group n=4 Participants This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period. Routine physiotherapy control: Provision of routine physiotherapy care as control	Therapeutic Wand Group n=5 Participants This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study.
Subjective Reports of Adverse Events	0 Number of adverse events	0 Number of adverse events

Adverse Events

Usual Physiotherapy Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Therapeutic Wand Group

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

Hilary Pape

University of Bradford

Phone: 01274 236228

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place