Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06268483
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2024-02-13
Brief Title:
Effect of Hyaluronic Acid Oral Supplementation on Sexual and Urinary Symptoms of Women With Recurrent Urinary Tract Infections
Sponsor:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study Overview
Official Title:
Effect of Hyaluronic Acid Oral Supplementation on Sexual and Urinary Symptoms of Women With Recurrent Urinary Tract Infections
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JalUrol
Brief Summary:
Uncomplicated urinary tract infections UTI are one of the most common bacterial infections globally causing a significant proportion of medical consultations in primary and outpatient settings Recurrent UTI rUTI have a detrimental impact on the patients quality of life causing a negative effect on womens social relationships self-esteem as well as irritability and tiredness Moreover several real-life studies have shown that reproductive-aged women with rUTI more frequently experience sexual dysfunction as compared to controls without infections The glycosaminoglycan layer of the bladder urothelium mainly composed by chondroitin sulfate CS and hyaluronic acid HA provides a protective barrier against the penetration of bacteria A deficiency of this layer facilitates bacterial adherence leading to recurrent infection Treatment to restore this layer with intravesical instillation of HA has been proven to reduce the incidence of rUTI episodes Furthermore intravesical instillation with HA has been associates with sexual function improvement in women with rUTI and painful bladder Therefore in conditions where the glycosaminoglycan layer of the bladder is impaired such as rUTIs treatment with HA to restore it appears to have a beneficial effect on urinary and sexual symptoms
Recently a randomized control trial has demonstrated that an oral formulation of HA CS quercetin and curcumin was effective in improving urinary symptoms in women undergoing intravesical chemotherapy for bladder cancer However there are no studies investigating the impact of the oral administration of HA and CS on the sexual and urinary symptoms of women with rUTI Since rUTI are highly prevalent in sexually active women and exert a detrimental impact on womens quality of life sexual and urinary symptoms the identification of oral treatments that could alleviate these bothersome consequences is of primary clinical importance
Therefore we will conduct this randomized cross-over trial to evaluate the efficacy of an oral preparation of HA CS N-Acetylglucosamine and vitamin C in improving sexual and urinary symptoms in a cohort of reproductive-aged women with rUTI
Methods
Pre-menopausal sexually active women referred to our center for symptomatic rUTIs At the time of enrollment participants were randomized with a 11 allocation ratio by means of a computer-generated random list in two groups intervention I and control C Figure 1
Inclusion and exclusion criteria We included sexually active reproductive-aged women with symptomatic rUTIs Exclusion criteria younger than 18 if they had used combined hormonal contraception during the previous 6 months pregnant breastfeeding or trying to conceive if they had symptoms of upper UTI a history of urinary tract anomaliesvesicoureteral reflux stress urinary incontinence interstitial cystitis diabetes urinary tract stones neurologic conditions clinical depression or depressive symptoms
All women will be assessed with a thorough medical and sexual history To psychometrically quantify sexual function impairment all participants completed The Female Sexual Function Index FSFI questionnaire at baseline and at each follow up assessment
Treatment Protocol Group I an oral preparation capsule of HA 100 mg CS 400 mg N-Acetylglucosamine 200 mg and vitamin C 80 mg once a day in the morning plus an oral preparation of cranberry D-mannose propolis extract tumeric and Boswellia twice a day for three months
Group C an oral preparation of cranberry D-mannose propolis extract tumeric and Boswellia twice a day for three months
After three months of treatment follow up 1 all women were evaluated with medical and sexual history Participants also completed the FSFI and IPSS questionnaires At this point the treatment was reversed crossover scheme for additional three months
At 6 months follow up follow up 2 participants were again investigated with medical and sexual history and the IPSS and FSFI were completed Figure 2 report the complete study design Monthly phone calls were performed to check for adherence to treatment
Statistics The sample size consisted of 25 participants in each group calculated by using the two-sample t-test analysis Baseline clinical and psychometric scores will be compared between I and C groups Second potential differences in FSFI values at 3-6 months follow-up assessment will be evaluated between and within groups Potential predictors of FSFI improvement will be evaluated
Recently a randomized control trial has demonstrated that an oral formulation of HA CS quercetin and curcumin was effective in improving urinary symptoms in women undergoing intravesical chemotherapy for bladder cancer However there are no studies investigating the impact of the oral administration of HA and CS on the sexual and urinary symptoms of women with rUTI Since rUTI are highly prevalent in sexually active women and exert a detrimental impact on womens quality of life sexual and urinary symptoms the identification of oral treatments that could alleviate these bothersome consequences is of primary clinical importance
Therefore we will conduct this randomized cross-over trial to evaluate the efficacy of an oral preparation of HA CS N-Acetylglucosamine and vitamin C in improving sexual and urinary symptoms in a cohort of reproductive-aged women with rUTI
Methods
Pre-menopausal sexually active women referred to our center for symptomatic rUTIs At the time of enrollment participants were randomized with a 11 allocation ratio by means of a computer-generated random list in two groups intervention I and control C Figure 1
Inclusion and exclusion criteria We included sexually active reproductive-aged women with symptomatic rUTIs Exclusion criteria younger than 18 if they had used combined hormonal contraception during the previous 6 months pregnant breastfeeding or trying to conceive if they had symptoms of upper UTI a history of urinary tract anomaliesvesicoureteral reflux stress urinary incontinence interstitial cystitis diabetes urinary tract stones neurologic conditions clinical depression or depressive symptoms
All women will be assessed with a thorough medical and sexual history To psychometrically quantify sexual function impairment all participants completed The Female Sexual Function Index FSFI questionnaire at baseline and at each follow up assessment
Treatment Protocol Group I an oral preparation capsule of HA 100 mg CS 400 mg N-Acetylglucosamine 200 mg and vitamin C 80 mg once a day in the morning plus an oral preparation of cranberry D-mannose propolis extract tumeric and Boswellia twice a day for three months
Group C an oral preparation of cranberry D-mannose propolis extract tumeric and Boswellia twice a day for three months
After three months of treatment follow up 1 all women were evaluated with medical and sexual history Participants also completed the FSFI and IPSS questionnaires At this point the treatment was reversed crossover scheme for additional three months
At 6 months follow up follow up 2 participants were again investigated with medical and sexual history and the IPSS and FSFI were completed Figure 2 report the complete study design Monthly phone calls were performed to check for adherence to treatment
Statistics The sample size consisted of 25 participants in each group calculated by using the two-sample t-test analysis Baseline clinical and psychometric scores will be compared between I and C groups Second potential differences in FSFI values at 3-6 months follow-up assessment will be evaluated between and within groups Potential predictors of FSFI improvement will be evaluated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Policlinico | OTHER | IRCCS Fondazione Ca Granda Ospedale Maggiore Policlinico | None |